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Trial Outcomes & Findings for Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals (NCT NCT06117020)

NCT ID: NCT06117020

Last Updated: 2026-06-05

Results Overview

To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

89 participants

Primary outcome timeframe

From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6)

Results posted on

2026-06-05

Participant Flow

Participant milestones

Participant milestones
Measure
Single Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Single Ascending Dose Level 3 - Active MTR-601
40 mg MTR-601 Fed
Single Ascending Dose Level 4 - Active MTR-601
80 mg MTR-601 Fed
Single Ascending Dose Level 5 - Active MTR-601
160 mg MTR-601 Fed
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed - Repeat of Dose Level 2
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Overall Study
STARTED
6
6
6
6
6
6
6
6
7
6
6
10
12
Overall Study
COMPLETED
6
6
6
6
6
6
6
6
6
6
6
10
11
Overall Study
NOT COMPLETED
0
0
0
0
0
0
0
0
1
0
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Single Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Single Ascending Dose Level 3 - Active MTR-601
40 mg MTR-601 Fed
Single Ascending Dose Level 4 - Active MTR-601
80 mg MTR-601 Fed
Single Ascending Dose Level 5 - Active MTR-601
160 mg MTR-601 Fed
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed - Repeat of Dose Level 2
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Overall Study
Physician Decision
0
0
0
0
0
0
0
0
1
0
0
0
0
Overall Study
Protocol Specified Withdrawal
0
0
0
0
0
0
0
0
0
0
0
0
1

Baseline Characteristics

Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Single Ascending Dose Level 3 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Single Ascending Dose Level 4 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Single Ascending Dose Level 5 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Multiple Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose- Placebo
n=10 Participants
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose- Placebo
n=12 Participants
Placebo: Multiple Ascending Dose comparator
Total
n=89 Participants
Total of all reporting groups
Age, Continuous
30.7 years
STANDARD_DEVIATION 6.38 • n=20 Participants
30.7 years
STANDARD_DEVIATION 7.47 • n=20 Participants
31.5 years
STANDARD_DEVIATION 7.23 • n=40 Participants
34.7 years
STANDARD_DEVIATION 6.02 • n=6 Participants
29.2 years
STANDARD_DEVIATION 1.72 • n=7 Participants
30.0 years
STANDARD_DEVIATION 5.76 • n=13 Participants
31.5 years
STANDARD_DEVIATION 6.66 • n=6 Participants
32.7 years
STANDARD_DEVIATION 8.76 • n=6 Participants
32.1 years
STANDARD_DEVIATION 4.38 • n=5 Participants
31.7 years
STANDARD_DEVIATION 5.65 • n=6 Participants
37.7 years
STANDARD_DEVIATION 5.96 • n=4 Participants
31.5 years
STANDARD_DEVIATION 6.69 • n=4 Participants
33.8 years
STANDARD_DEVIATION 7.47 • n=4 Participants
32.2 years
STANDARD_DEVIATION 6.40 • n=73 Participants
Sex: Female, Male
Female
2 Participants
n=20 Participants
1 Participants
n=20 Participants
3 Participants
n=40 Participants
3 Participants
n=6 Participants
3 Participants
n=7 Participants
2 Participants
n=13 Participants
2 Participants
n=6 Participants
2 Participants
n=6 Participants
2 Participants
n=5 Participants
1 Participants
n=6 Participants
1 Participants
n=4 Participants
6 Participants
n=4 Participants
4 Participants
n=4 Participants
32 Participants
n=73 Participants
Sex: Female, Male
Male
4 Participants
n=20 Participants
5 Participants
n=20 Participants
3 Participants
n=40 Participants
3 Participants
n=6 Participants
3 Participants
n=7 Participants
4 Participants
n=13 Participants
4 Participants
n=6 Participants
4 Participants
n=6 Participants
5 Participants
n=5 Participants
5 Participants
n=6 Participants
5 Participants
n=4 Participants
4 Participants
n=4 Participants
8 Participants
n=4 Participants
57 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=20 Participants
1 Participants
n=20 Participants
3 Participants
n=40 Participants
4 Participants
n=6 Participants
4 Participants
n=7 Participants
2 Participants
n=13 Participants
2 Participants
n=6 Participants
4 Participants
n=6 Participants
4 Participants
n=5 Participants
4 Participants
n=6 Participants
3 Participants
n=4 Participants
7 Participants
n=4 Participants
9 Participants
n=4 Participants
48 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants
n=20 Participants
5 Participants
n=20 Participants
3 Participants
n=40 Participants
2 Participants
n=6 Participants
2 Participants
n=7 Participants
4 Participants
n=13 Participants
4 Participants
n=6 Participants
2 Participants
n=6 Participants
3 Participants
n=5 Participants
2 Participants
n=6 Participants
2 Participants
n=4 Participants
3 Participants
n=4 Participants
3 Participants
n=4 Participants
40 Participants
n=73 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
1 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
1 Participants
n=73 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
1 Participants
n=4 Participants
1 Participants
n=73 Participants
Race (NIH/OMB)
Asian
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
1 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
1 Participants
n=73 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=73 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=20 Participants
4 Participants
n=20 Participants
1 Participants
n=40 Participants
1 Participants
n=6 Participants
1 Participants
n=7 Participants
4 Participants
n=13 Participants
2 Participants
n=6 Participants
1 Participants
n=6 Participants
3 Participants
n=5 Participants
2 Participants
n=6 Participants
4 Participants
n=4 Participants
2 Participants
n=4 Participants
2 Participants
n=4 Participants
29 Participants
n=73 Participants
Race (NIH/OMB)
White
4 Participants
n=20 Participants
2 Participants
n=20 Participants
3 Participants
n=40 Participants
5 Participants
n=6 Participants
5 Participants
n=7 Participants
2 Participants
n=13 Participants
4 Participants
n=6 Participants
4 Participants
n=6 Participants
4 Participants
n=5 Participants
4 Participants
n=6 Participants
1 Participants
n=4 Participants
7 Participants
n=4 Participants
9 Participants
n=4 Participants
54 Participants
n=73 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
0 Participants
n=4 Participants
1 Participants
n=4 Participants
0 Participants
n=4 Participants
2 Participants
n=73 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
2 Participants
n=40 Participants
0 Participants
n=6 Participants
0 Participants
n=7 Participants
0 Participants
n=13 Participants
0 Participants
n=6 Participants
0 Participants
n=6 Participants
0 Participants
n=5 Participants
0 Participants
n=6 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
2 Participants
n=73 Participants
Region of Enrollment
United States
6 participants
n=20 Participants
6 participants
n=20 Participants
6 participants
n=40 Participants
6 participants
n=6 Participants
6 participants
n=7 Participants
6 participants
n=13 Participants
6 participants
n=6 Participants
6 participants
n=6 Participants
7 participants
n=5 Participants
6 participants
n=6 Participants
6 participants
n=4 Participants
10 participants
n=4 Participants
12 participants
n=4 Participants
89 participants
n=73 Participants

PRIMARY outcome

Timeframe: From baseline to last follow-up visit (Day 7 for SAD Dose Levels 1, 3, and 4, Day 12 for SAD Dose Level 2, Day 20 MAD Dose Levels 1-6)

Population: The number of participants and events analyzed does not differ from the number of participants or events assigned to the arm or placebo group.

To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions.

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
n=10 Participants
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
n=12 Participants
Placebo: Multiple Ascending Dose Comparator
Incidence, Severity and Relatedness of Treatment-emergent Adverse Events (TEAEs). TEAE Severity Will be Measured as Mild, Moderate or Severe, and Relatedness Will be Either Related or Not Related.
1 Number of events
1 Number of events
3 Number of events
2 Number of events
8 Number of events
0 Number of events
8 Number of events
6 Number of events
12 Number of events
23 Number of events
10 Number of events
15 Number of events
8 Number of events
28 Number of events

SECONDARY outcome

Timeframe: Day 1

To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration (Cmax) of MTR-601 In Single Ascending Doses
15.2 ng/mL
Standard Deviation 65.3
39.8 ng/mL
Standard Deviation 23.4
74.6 ng/mL
Standard Deviation 50.0
115.0 ng/mL
Standard Deviation 63.0
247.0 ng/mL
Standard Deviation 37.0
29.5 ng/mL
Standard Deviation 32.9
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 1

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration (Cmax) of MTR-601 in Multiple Ascending Doses
15.7 ng/mL
Standard Deviation 50.4
41.2 ng/mL
Standard Deviation 44.8
86.9 ng/mL
Standard Deviation 69.3
101.0 ng/mL
Standard Deviation 31.8
237.0 ng/mL
Standard Deviation 39.9
36.4 ng/mL
Standard Deviation 20.2
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 7

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 7

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration (Cmax) of MTR-601 in Multiple Ascending Doses
24.7 ng/mL
Standard Deviation 39.0
64.8 ng/mL
Standard Deviation 34.5
150.0 ng/mL
Standard Deviation 48.1
176.0 ng/mL
Standard Deviation 37.7
336.0 ng/mL
Standard Deviation 39.5
51.0 ng/mL
Standard Deviation 42.7
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration at Steady State (Cmax, ss) of MTR-601 in Multiple Ascending Doses
30.1 ng/mL
Standard Deviation 39.3
83.0 ng/mL
Standard Deviation 38.4
158.0 ng/mL
Standard Deviation 45.1
234.0 ng/mL
Standard Deviation 31.3
365.0 ng/mL
Standard Deviation 34.0
59.9 ng/mL
Standard Deviation 28.6
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Single Ascending Doses
2.00 h
Interval 1.5 to 4.0
2.00 h
Interval 1.55 to 4.0
3.00 h
Interval 2.0 to 8.0
3.00 h
Interval 2.0 to 4.0
4.00 h
Interval 1.98 to 8.03
1.52 h
Interval 1.0 to 2.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 1

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Multiple Ascending Doses
2.02 h
Interval 1.5 to 4.0
3.00 h
Interval 1.5 to 4.0
2.00 h
Interval 2.0 to 4.0
2.00 h
Interval 1.5 to 6.0
2.00 h
Interval 1.5 to 4.0
2.00 h
Interval 1.5 to 4.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 7

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 7

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Time to Maximum Plasma Concentration (Tmax) of MTR-601 in Multiple Ascending Doses
4.00 h
Interval 2.0 to 6.0
3.01 h
Interval 2.0 to 4.07
3.00 h
Interval 2.0 to 4.0
2.00 h
Interval 2.0 to 4.0
4.00 h
Interval 1.0 to 4.0
4.00 h
Interval 2.0 to 4.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To Evaluate the Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of MTR-601 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Time to Maximum Plasma Concentration at Steady State (Tmax, ss) of MTR-601 in Multiple Ascending Doses
2.00 h
Interval 2.0 to 4.0
3.00 h
Interval 1.5 to 4.02
2.00 h
Interval 2.0 to 4.0
4.00 h
Interval 2.0 to 4.0
4.00 h
Interval 2.0 to 4.07
3.00 h
Interval 2.0 to 8.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 0-24 Hours

To evaluate the Plasma area under the curve (AUC0-24) of MTR-601 in Single Ascending Doses to 24 Hours

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Plasma Area Under the Curve Through 24 Hours (AUC0-24) of MTR-601 in Single Ascending Doses
134.0 h*ng/mL
Standard Deviation 60.6
335.0 h*ng/mL
Standard Deviation 25.9
718.0 h*ng/mL
Standard Deviation 34.3
1140.0 h*ng/mL
Standard Deviation 53.5
2470.0 h*ng/mL
Standard Deviation 29.6
265.0 h*ng/mL
Standard Deviation 35.6
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 0-96 hours

To extraplolate the plasma Area Under the Curve to infinite time of MTR-601 in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Plasma Area Under the Curve to Infinity (AUCinf) of MTR-601 in Single Ascending Dose
369 h*ng/mL
Standard Deviation 58.5
961 h*ng/mL
Standard Deviation 44.9
1740 h*ng/mL
Standard Deviation 36.0
3270 h*ng/mL
Standard Deviation 55.9
7210 h*ng/mL
Standard Deviation 34.00
627 h*ng/mL
Standard Deviation 6.48
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 0-96 Hours

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Plasma Half-life (T1/2) of MTR-601 in Single Ascending Doses
43.0 h
Standard Error 24.2
59.9 h
Standard Error 38.5
38.3 h
Standard Error 24.7
39.9 h
Standard Error 22.2
38.0 h
Standard Error 44.0
43.5 h
Standard Error 20.3
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 0-96 Hours

To evaluate the plasma concentration corresponding to the time of last measurable observation of MTR-601 in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Plasma Concentration Corresponding to the Time of Last Measurable Observation (Clast)
1.06 ng/mL
Standard Deviation 55.9
3.57 ng/mL
Standard Deviation 46.5
4.83 ng/mL
Standard Deviation 49.4
10.2 ng/mL
Standard Deviation 61.4
22.9 ng/mL
Standard Deviation 25.5
3.27 ng/mL
Standard Deviation 41.7
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 0-96 Hours

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Plasma Clearance of Drug After Extravascular Administration (CL/F) in Single Ascending Doses
27.1 L/h
Standard Deviation 58.5
20.8 L/h
Standard Deviation 44.9
22.9 L/h
Standard Deviation 36.0
24.5 L/h
Standard Deviation 55.9
22.2 L/h
Standard Deviation 34
31.9 L/h
Standard Deviation 6.48
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: 0-96 Hours

To evaluate the volume of distribution after extravascular administration (Vz/F) of MTR-901 in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Single Ascending Doses
1550.0 L
Standard Deviation 61.0
1530.0 L
Standard Deviation 40.3
1270.0 L
Standard Deviation 39.7
1410.0 L
Standard Deviation 63.5
1110.0 L
Standard Deviation 68.4
1580.0 L
Standard Deviation 21.8
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

Population: Samples were not collected from early dose levels 1-3 because the team added new PK sample time points for later dose levels via protocol amendment after the study had already started and earlier dose levels were already enrolled.

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 1

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=7 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
20.5 ng/mL
Standard Deviation 31.4
63.2 ng/mL
Standard Deviation 79.0
—
—
—
25.2 ng/mL
Standard Deviation 53.6
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 7

Population: Samples were not collected from early dose levels 1-3 because the team added new PK sample time points for later dose levels via protocol amendment after the study had already started and earlier dose levels were already enrolled.

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 7

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
64.3 ng/mL
Standard Deviation 41.4
171.0 ng/mL
Standard Deviation 36.2
—
—
—
85.8 ng/mL
Standard Deviation 47.4
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

Population: Samples were not collected from early dose levels 1-3 because the team added new PK sample time points for later dose levels via protocol amendment after the study had already started and earlier dose levels were already enrolled.

To evaluate the plasma pharmacokinetics (PK) of MTR-601 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Plasma Concentration at 24 Hours (C24) of MTR-601 in Multiple Ascending Doses
74.2 ng/mL
Standard Deviation 58.6
187.0 ng/mL
Standard Deviation 22.8
—
—
—
100.0 ng/mL
Standard Deviation 52.3
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

To evaluate the Area Under the Curve over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses on Day 1

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Area Under the Curve Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
84.6 h*ng/mL
Standard Deviation 51.8
341.0 h*ng/mL
Standard Deviation 43.5
792.0 h*ng/mL
Standard Deviation 28.3
929.0 h*ng/mL
Standard Deviation 21.6
2130.0 h*ng/mL
Standard Deviation 60.0
201.0 h*ng/mL
Standard Deviation 31.4
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 7

To evaluate the Area Under the Curve over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses on Day 7

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Area Under the Curve Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
180.0 h*ng/mL
Standard Deviation 30.6
869.0 h*ng/mL
Standard Deviation 32.3
2040.0 h*ng/mL
Standard Deviation 37.2
2610.0 h*ng/mL
Standard Deviation 42.8
5030.0 h*ng/mL
Standard Deviation 36.4
431.0 h*ng/mL
Standard Deviation 35.9
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate the Area Under the Curve at Steady State over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Area Under the Curve at Steady State Over the Dosing Interval (AUCtau) of MTR-601 in Multiple Ascending Doses
380.0 h*ng/mL
Standard Deviation 29.6
1080.0 h*ng/mL
Standard Deviation 38.5
2310.0 h*ng/mL
Standard Deviation 47.9
3180.0 h*ng/mL
Standard Deviation 46.0
5600.0 h*ng/mL
Standard Deviation 31.3
882.0 h*ng/mL
Standard Deviation 36.2
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate the Average plasma drug concentration of MTR-601 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Average Plasma Drug Concentration of MTR-601 in Multiple Ascending Doses
15.8 ng/mL
Standard Deviation 29.6
45.2 ng/mL
Standard Deviation 38.5
96.1 ng/mL
Standard Deviation 47.9
132.0 ng/mL
Standard Deviation 46.0
233.0 ng/mL
Standard Deviation 31.3
36.7 ng/mL
Standard Deviation 36.2
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate the Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Volume of Distribution After Extravascular Administration (Vz/F) of MTR-901 in Multiple Ascending Doses
1950.0 L
Standard Deviation 63.4
1780.0 L
Standard Deviation 128.0
1440.0 L
Standard Deviation 42.7
2100.0 L
Standard Deviation 65.9
1960.0 L
Standard Deviation 24.4
1800.0 L
Standard Deviation 49.3
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

Population: Samples were not collected from early dose levels 1-3 because the team added new PK sample time points for later dose levels via protocol amendment after the study had already started and earlier dose levels were already enrolled.

To evaluate the Accumulation Ratio of Maximum Plasma Concentration (AR\_Cmax) of MTR-901 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=7 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Accumulation Ratio of Maximum Plasma Concentration (AR_Cmax) of MTR-901 in Multiple Ascending Doses
2.01 Ratio
Standard Deviation 23.9
2.3 Ratio
Standard Deviation 37.3
1.54 Ratio
Standard Deviation 20.8
—
—
1.54 Ratio
Standard Deviation 42.3
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

Population: Samples were not collected from early dose levels 1-3 because the team added new PK sample time points for later dose levels via protocol amendment after the study had already started and earlier dose levels were already enrolled.

To evaluate the Maximum Accumulation Concentration of Area Under the Curve (AR\_AUC0-24, qd) of MTR-901 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=7 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Maximum Accumulation Concentration of Area Under the Curve (AR_AUC0-24, qd) of MTR-901 in Multiple Ascending Doses
3.18 Ratio
Standard Deviation 17.3
3.42 Ratio
Standard Deviation 27.6
2.63 Ratio
Standard Deviation 35.7
—
—
2.91 Ratio
Standard Deviation 37.9
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate the Plasma Clearance of Drug After Extravascular Administration (CL/F) of MTR-601 in Multiple Ascending Doses on Day 14

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Plasma Clearance of Drug After Extravascular Administration (CL/F) of MTR-601 in Multiple Ascending Doses
26.3 L/h
Standard Deviation 29.6
18.4 L/h
Standard Deviation 38.5
17.3 L/h
Standard Deviation 47.9
25.2 L/h
Standard Deviation 46.0
28.6 L/h
Standard Deviation 31.3
22.7 L/h
Standard Deviation 36.2
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Up to 96 Hours

To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) in Single Ascending Doses
0.00577 mg
Standard Deviation 34.7
0.0124 mg
Standard Deviation 41.6
0.0383 mg
Standard Deviation 77.0
0.0544 mg
Standard Deviation 29.0
0.123 mg
Standard Deviation 46.2
0.0107 mg
Standard Deviation 39.1
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Up to 96 Hours

To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Single Ascending Doses
0.0577 % of dose
Standard Deviation 34.7
0.0618 % of dose
Standard Deviation 41.6
0.0957 % of dose
Standard Deviation 77.0
0.0681 % of dose
Standard Deviation 29.0
0.0771 % of dose
Standard Deviation 46.2
0.0535 % of dose
Standard Deviation 39.1
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Up to 96 Hours

To evaluate the Renal Clearance (Clr) of MTR-601 in Single Ascending Doses in Single Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Renal Clearance (Clr) of MTR-601 in Single Ascending Doses
0.0152 L/h
Standard Deviation 39.2
0.0122 L/h
Standard Deviation 34.7
0.0188 L/h
Standard Deviation 53.5
0.0187 L/h
Standard Deviation 60.4
0.017 L/h
Standard Deviation 40.4
0.0184 L/h
Standard Deviation 11.5
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
0.0015 mg
Standard Deviation 96.4
0.007 mg
Standard Deviation 52.9
0.00684 mg
Standard Deviation 432.0
0.0314 mg
Standard Deviation 70.4
0.0602 mg
Standard Deviation 49.6
0.00689 mg
Standard Deviation 124.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 1

To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
0.015 % of dose
Standard Error 96.4
0.035 % of dose
Standard Error 52.9
0.0171 % of dose
Standard Error 432.0
0.0392 % of dose
Standard Error 70.4
0.0376 % of dose
Standard Error 49.6
0.0345 % of dose
Standard Error 124.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 7

To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
0.021 mg
Standard Deviation 62.0
0.0351 mg
Standard Deviation 93.3
0.0828 mg
Standard Deviation 131.0
0.257 mg
Standard Deviation 104.0
0.471 mg
Standard Deviation 78.4
0.0484 mg
Standard Deviation 103.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 7

To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
0.21 % of dose
Standard Error 62.0
0.176 % of dose
Standard Error 93.3
0.207 % of dose
Standard Error 131.0
0.321 % of dose
Standard Error 104.0
0.294 % of dose
Standard Error 78.4
0.242 % of dose
Standard Error 103.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate the Cumulative amount of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Cumulative Amount of MTR-601 Excreted Unchanged in Urine (Ae) In Multiple Ascending Doses
0.0105 mg
Standard Deviation 68.4
0.0172 mg
Standard Deviation 98.1
0.0488 mg
Standard Deviation 67.9
0.151 mg
Standard Deviation 129.0
0.243 mg
Standard Deviation 81.0
0.0269 mg
Standard Deviation 112.0
—
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Day 14

To evaluate theFraction of Dose of MTR-601 Excreted Unchanged in Urine in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 Participants
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 Participants
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Fraction of Dose of MTR-601 Excreted Unchanged in Urine (Fe) in Multiple Ascending Doses
0.105 % of dose
Standard Error 68.4
0.0858 % of dose
Standard Error 98.1
0.122 % of dose
Standard Error 67.9
0.188 % of dose
Standard Error 129.0
0.152 % of dose
Standard Error 81.0
0.135 % of dose
Standard Error 112.0
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—
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SECONDARY outcome

Timeframe: Day 14

Population: Samples were not collected from early dose levels 1-3 because the team added new PK sample time points for later dose levels via protocol amendment after the study had already started and earlier dose levels were already enrolled.

To evaluate the Renal Clearance (Clr) of MTR-601 in Multiple Ascending Doses

Outcome measures

Outcome measures
Measure
Single Ascending Dose Level 1 - Active MTR-601
n=6 Participants
10 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 Participants
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=6 Participants
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 Participants
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Multiple Ascending Dose Level 1 - Active MTR-601
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
80 mg MTR-601 Fed
Multiple Ascending Dose Level 6 - Active MTR-601
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
Placebo: Multiple Ascending Dose Comparator
Renal Clearance (Clr) of MTR-601 in Multiple Ascending Doses
0.00759 L/h
Standard Deviation 104.0
0.0258 L/h
Standard Deviation 78.6
0.0227 L/h
Standard Deviation 47.8
—
—
0.0106 L/h
Standard Deviation 52.9
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—
—
—
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—
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Adverse Events

Multiple Ascending Dose Level 6 - Active MTR-601

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Single Ascending Dose - Placebo

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Multiple Ascending Dose - Placebo

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Single Ascending Dose Level 1 - Active MTR-601

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Single Ascending Dose Level 2 - Active MTR-601 (Fast)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Single Ascending Dose Level 2 - Active MTR-601 (Fed)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Single Ascending Dose Level 3 - Active MTR-601

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Single Ascending Dose Level 4 - Active MTR-601

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Single Ascending Dose Level 5 - Active MTR-601

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Multiple Ascending Dose Level 1 - Active MTR-601

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Multiple Ascending Dose Level 2 - Active MTR-601

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Multiple Ascending Dose Level 3 - Active MTR-601

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Multiple Ascending Dose Level 4 - Active MTR-601

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Multiple Ascending Dose Level 5 - Active MTR-601

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Multiple Ascending Dose Level 6 - Active MTR-601
n=6 participants at risk
160 mg MTR-601 Fed
Single Ascending Dose - Placebo
n=10 participants at risk
Placebo: Single Ascending Dose comparator
Multiple Ascending Dose - Placebo
n=12 participants at risk
Placebo: Multiple Ascending Dose Comparator
Single Ascending Dose Level 1 - Active MTR-601
n=6 participants at risk
10 mg MTR-601 Fed
Single Ascending Dose Level 2 - Active MTR-601 (Fast)
n=6 participants at risk
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Single Ascending Dose Level 2 - Active MTR-601 (Fed)
n=6 participants at risk
20 mg MTR-601: For the first dose, subjects were fasting; for the second dose, subjects were fed a standard not-high fat breakfast 30 minutes before dosing.
Single Ascending Dose Level 3 - Active MTR-601
n=6 participants at risk
40 mg MTR-601 Fed
Single Ascending Dose Level 4 - Active MTR-601
n=6 participants at risk
80 mg MTR-601 Fed
Single Ascending Dose Level 5 - Active MTR-601
n=6 participants at risk
160 mg MTR-601 Fed
Multiple Ascending Dose Level 1 - Active MTR-601
n=6 participants at risk
10 mg MTR-601 Fed
Multiple Ascending Dose Level 2 - Active MTR-601
n=6 participants at risk
20 mg MTR-601 Fed
Multiple Ascending Dose Level 3 - Active MTR-601
n=6 participants at risk
20 mg MTR-601 Fed
Multiple Ascending Dose Level 4 - Active MTR-601
n=7 participants at risk
40 mg MTR-601 Fed
Multiple Ascending Dose Level 5 - Active MTR-601
n=6 participants at risk
80 mg MTR-601 Fed
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
33.3%
2/6 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
33.3%
2/6 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Nervous system disorders
Dizziness
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
10.0%
1/10 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
42.9%
3/7 • Number of events 3 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
33.3%
2/6 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Nervous system disorders
Headach
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Eye disorders
Visual impairment
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
33.3%
2/6 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
28.6%
2/7 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Diarrhoea
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
10.0%
1/10 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Toothache
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Constipation
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
20.0%
2/10 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
General disorders
Medical device site reaction
66.7%
4/6 • Number of events 4 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
10.0%
1/10 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
66.7%
8/12 • Number of events 10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
83.3%
5/6 • Number of events 5 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
83.3%
5/6 • Number of events 5 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
66.7%
4/6 • Number of events 4 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
71.4%
5/7 • Number of events 5 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
50.0%
3/6 • Number of events 3 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
General disorders
Vessel puncture site haemmorrhage
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Cardiac disorders
Tachycardia
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
10.0%
1/10 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Cardiac disorders
Tachycardia paroxysmal;
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
10.0%
1/10 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
10.0%
1/10 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
General disorders
Maxillofacial pain
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
General disorders
Non-cardiac chest pain
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
28.6%
2/7 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Injury, poisoning and procedural complications
Mouth injury
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Eye disorders
Photophobia
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Injury, poisoning and procedural complications
Scratch
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Blood and lymphatic system disorders
Leukopenia
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Eye disorders
Dry eye
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Abdominal pain
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Eructation
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Frequent bowel movements
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Nausea
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Gastrointestinal disorders
Vomiting
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Infections and infestations
Hordeolum
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Nervous system disorders
Sciatica
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Nervous system disorders
Somolence
83.3%
5/6 • Number of events 5 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
28.6%
2/7 • Number of events 2 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Nervous system disorders
Speech disorder
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
14.3%
1/7 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Psychiatric disorders
Anxiety
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Reproductive system and breast disorders
Dysmenorrhoea
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Skin and subcutaneous tissue disorders
Pruritus
16.7%
1/6 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/12 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
Skin and subcutaneous tissue disorders
Hot flush
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/10 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
8.3%
1/12 • Number of events 1 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/7 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.
0.00%
0/6 • All SAEs and AEs will be recorded from first dose of study medication to the last follow-up visit (SAD Cohorts 1, 3, 4 and 5 - Day 7, SAD Cohort 2 - Day 12, MAD Cohorts 1-6 - Day 20)
The definitions of adverse event and serious adverse event in the protocol are consistent with the those defined by clinicaltrials.gov.

Additional Information

Associate Director, Clinical Operations

Motric Bio, Inc.

Phone: 510-929-2844

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place