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Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women (NCT NCT03822078)

NCT ID: NCT03822078

Last Updated: 2019-07-24

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

45 participants

Primary outcome timeframe

From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts

Results posted on

2019-07-24

Participant Flow

This study was conducted at one clinical center in Japan.

The study consisted of 5 dose cohorts of 8 participants. Within each dose cohort 6 participants were randomly assigned to receive denosumab and 2 participants to receive placebo.

Participant milestones

Participant milestones
Measure
Placebo
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Overall Study
STARTED
12
6
6
8
7
6
Overall Study
Received Study Drug
10
6
6
6
6
6
Overall Study
COMPLETED
10
6
6
6
6
6
Overall Study
NOT COMPLETED
2
0
0
2
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=12 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=8 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=7 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Total
n=45 Participants
Total of all reporting groups
Age, Continuous
59.83 years
STANDARD_DEVIATION 2.86 • n=99 Participants
59.67 years
STANDARD_DEVIATION 2.34 • n=107 Participants
59.50 years
STANDARD_DEVIATION 3.39 • n=206 Participants
58.88 years
STANDARD_DEVIATION 3.80 • n=7 Participants
56.43 years
STANDARD_DEVIATION 3.95 • n=31 Participants
58.67 years
STANDARD_DEVIATION 2.34 • n=30 Participants
58.91 years
STANDARD_DEVIATION 3.22 • n=3 Participants
Sex: Female, Male
Female
12 Participants
n=99 Participants
6 Participants
n=107 Participants
6 Participants
n=206 Participants
8 Participants
n=7 Participants
7 Participants
n=31 Participants
6 Participants
n=30 Participants
45 Participants
n=3 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race/Ethnicity, Customized
Japanese
12 Participants
n=99 Participants
6 Participants
n=107 Participants
6 Participants
n=206 Participants
8 Participants
n=7 Participants
7 Participants
n=31 Participants
6 Participants
n=30 Participants
45 Participants
n=3 Participants

PRIMARY outcome

Timeframe: From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts

Population: All treated participants

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Number of Participants With Adverse Events
Any adverse event
6 Participants
2 Participants
3 Participants
5 Participants
6 Participants
5 Participants
Number of Participants With Adverse Events
Serious adverse events
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Adverse Events
Treatment-related adverse events
4 Participants
0 Participants
1 Participants
3 Participants
4 Participants
4 Participants
Number of Participants With Adverse Events
Discontinuation due to adverse events
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With Adverse Events
Deaths on study
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts

Population: All participants who received denosumab

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab
2.06 μg*day/mL
Standard Deviation 0.53
15.2 μg*day/mL
Standard Deviation 6.7
84.3 μg*day/mL
Standard Deviation 20.1
481 μg*day/mL
Standard Deviation 131
1790 μg*day/mL
Standard Deviation 650
—

SECONDARY outcome

Timeframe: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Maximum Observed Concentration of Denosumab (Cmax)
99.6 ng/mL
Standard Deviation 25.8
492 ng/mL
Standard Deviation 166
1910 ng/mL
Standard Deviation 658
8690 ng/mL
Standard Deviation 2170
27400 ng/mL
Standard Deviation 7880
—

SECONDARY outcome

Timeframe: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts

Population: All participants who received denosumab

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Time to Maximum Observed Concentration (Tmax) of Denosumab
7.0 days
Interval 7.0 to 10.0
12.0 days
Interval 7.0 to 21.0
14.0 days
Interval 7.0 to 21.0
14.0 days
Interval 10.0 to 21.0
14.0 days
Interval 14.0 to 42.0
—

SECONDARY outcome

Timeframe: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts

Population: All participants who received denosumab

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Apparent Clearance (CL/F) of Denosumab
15.3 mL/day/kg
Standard Deviation 4.2
8.31 mL/day/kg
Standard Deviation 4.97
3.72 mL/day/kg
Standard Deviation 0.89
2.20 mL/day/kg
Standard Deviation 0.56
1.85 mL/day/kg
Standard Deviation 0.58
—

SECONDARY outcome

Timeframe: Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts

Population: All participants who received denosumab

Outcome measures

Outcome measures
Measure
Placebo
n=6 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration
15.5 days
Standard Deviation 4.7
22.5 days
Standard Deviation 3.9
33.6 days
Standard Deviation 5.8
42.6 days
Standard Deviation 7.0
51.4 days
Standard Deviation 5.8
—

SECONDARY outcome

Timeframe: Baseline and day 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only).

Population: Treated participants with available data at each time point

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 8
16 percent change
Standard Error 7
-12 percent change
Standard Error 13
-55 percent change
Standard Error 7
-64 percent change
Standard Error 5
-57 percent change
Standard Error 7
-64 percent change
Standard Error 10
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 11
3 percent change
Standard Error 8
-36 percent change
Standard Error 5
-67 percent change
Standard Error 5
-65 percent change
Standard Error 7
-69 percent change
Standard Error 6
-79 percent change
Standard Error 3
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 113
-5 percent change
Standard Error 6
3 percent change
Standard Error 4
-30 percent change
Standard Error 15
-53 percent change
Standard Error 10
-77 percent change
Standard Error 3
-84 percent change
Standard Error 2
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 141
-7 percent change
Standard Error 9
—
—
-51 percent change
Standard Error 5
-62 percent change
Standard Error 5
-81 percent change
Standard Error 3
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 2
12 percent change
Standard Error 11
6 percent change
Standard Error 4
-25 percent change
Standard Error 8
-22 percent change
Standard Error 11
-40 percent change
Standard Error 7
-64 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 3
19 percent change
Standard Error 5
-6 percent change
Standard Error 7
-30 percent change
Standard Error 5
-40 percent change
Standard Error 11
-51 percent change
Standard Error 8
-60 percent change
Standard Error 3
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 4
7 percent change
Standard Error 6
-18 percent change
Standard Error 9
-37 percent change
Standard Error 16
-48 percent change
Standard Error 11
-55 percent change
Standard Error 6
-62 percent change
Standard Error 5
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 5
23 percent change
Standard Error 10
-12 percent change
Standard Error 12
-44 percent change
Standard Error 5
-51 percent change
Standard Error 8
-53 percent change
Standard Error 8
-66 percent change
Standard Error 6
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 6
9 percent change
Standard Error 7
-1 percent change
Standard Error 18
-53 percent change
Standard Error 8
-62 percent change
Standard Error 7
-59 percent change
Standard Error 6
-72 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 15
4 percent change
Standard Error 3
-51 percent change
Standard Error 4
-68 percent change
Standard Error 4
-71 percent change
Standard Error 5
-71 percent change
Standard Error 5
-77 percent change
Standard Error 5
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 22
-1 percent change
Standard Error 5
-41 percent change
Standard Error 4
-71 percent change
Standard Error 6
-70 percent change
Standard Error 7
-70 percent change
Standard Error 5
-82 percent change
Standard Error 3
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 29
-1 percent change
Standard Error 5
-39 percent change
Standard Error 5
-68 percent change
Standard Error 3
-67 percent change
Standard Error 6
-64 percent change
Standard Error 7
-77 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 43
-1 percent change
Standard Error 5
-33 percent change
Standard Error 6
-67 percent change
Standard Error 4
-68 percent change
Standard Error 7
-69 percent change
Standard Error 8
-81 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 57
0 percent change
Standard Error 8
-14 percent change
Standard Error 3
-59 percent change
Standard Error 6
-64 percent change
Standard Error 8
-56 percent change
Standard Error 10
-79 percent change
Standard Error 6
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 71
-5 percent change
Standard Error 7
-23 percent change
Standard Error 6
-48 percent change
Standard Error 10
-65 percent change
Standard Error 6
-68 percent change
Standard Error 5
-82 percent change
Standard Error 3
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 85
8 percent change
Standard Error 7
4 percent change
Standard Error 8
-48 percent change
Standard Error 12
-58 percent change
Standard Error 9
-68 percent change
Standard Error 4
-83 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 99
1 percent change
Standard Error 6
4 percent change
Standard Error 6
-37 percent change
Standard Error 15
-64 percent change
Standard Error 5
-72 percent change
Standard Error 4
-77 percent change
Standard Error 10
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 169
-15 percent change
Standard Error 6
—
6 percent change
Standard Error 14
-41 percent change
Standard Error 11
-48 percent change
Standard Error 9
-78 percent change
Standard Error 5
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 197
-3 percent change
Standard Error 5
—
—
—
-47 percent change
Standard Error 8
-79 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 225
-7 percent change
Standard Error 11
—
42.0 percent change
-30 percent change
Standard Error 4
-20 percent change
Standard Error 17
-70 percent change
Standard Error 4
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 253
-13 percent change
Standard Error 10
—
—
—
-25 percent change
Standard Error 14
-62 percent change
Standard Error 5
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 281
—
—
—
-13 percent change
Standard Error 8
—
—
Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Day 309
—
—
—
—
-19 percent change
Standard Error 13
-23 percent change
Standard Error 12

SECONDARY outcome

Timeframe: Baseline and day 8, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, and 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only)

Population: Treated participants with available data at each time point

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 8
-0.4 percent change
Standard Error 2.8
-6.9 percent change
Standard Error 5.9
16.6 percent change
Standard Error 4.7
7.1 percent change
Standard Error 2.0
-0.5 percent change
Standard Error 5.1
3.1 percent change
Standard Error 6.4
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 15
-2.1 percent change
Standard Error 1.4
1.1 percent change
Standard Error 3.1
8.6 percent change
Standard Error 2.0
13.2 percent change
Standard Error 2.0
5.6 percent change
Standard Error 5.9
11.5 percent change
Standard Error 7.8
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 22
1.1 percent change
Standard Error 2.8
12.7 percent change
Standard Error 3.1
5.8 percent change
Standard Error 2.3
7.8 percent change
Standard Error 3.8
7.0 percent change
Standard Error 5.3
9.7 percent change
Standard Error 5.8
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 29
5.3 percent change
Standard Error 2.9
8.9 percent change
Standard Error 3.6
11.0 percent change
Standard Error 3.5
-0.7 percent change
Standard Error 2.8
5.8 percent change
Standard Error 4.2
-0.4 percent change
Standard Error 4.5
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 43
3.6 percent change
Standard Error 3.1
-2.3 percent change
Standard Error 2.8
-7.6 percent change
Standard Error 4.3
-20.3 percent change
Standard Error 3.2
-10.2 percent change
Standard Error 4.0
-14.7 percent change
Standard Error 2.6
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 57
2.7 percent change
Standard Error 1.6
-5.9 percent change
Standard Error 5.1
-19.2 percent change
Standard Error 2.8
-33.1 percent change
Standard Error 3.1
-21.0 percent change
Standard Error 4.9
-24.0 percent change
Standard Error 2.6
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 71
-0.9 percent change
Standard Error 3.0
-5.5 percent change
Standard Error 4.8
-29.0 percent change
Standard Error 5.7
-41.0 percent change
Standard Error 2.2
-36.1 percent change
Standard Error 5.2
-33.9 percent change
Standard Error 4.7
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 85
1.3 percent change
Standard Error 2.2
-7.9 percent change
Standard Error 6.3
-27.2 percent change
Standard Error 6.1
-47.7 percent change
Standard Error 3.2
-42.1 percent change
Standard Error 4.2
-43.9 percent change
Standard Error 1.9
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 99
1.7 percent change
Standard Error 3.2
-13.1 percent change
Standard Error 3.3
-33.4 percent change
Standard Error 5.5
-49.4 percent change
Standard Error 3.0
-44.0 percent change
Standard Error 5.5
-47.5 percent change
Standard Error 2.7
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 113
3.1 percent change
Standard Error 2.3
-0.5 percent change
Standard Error 7.1
-32.6 percent change
Standard Error 5.4
-54.2 percent change
Standard Error 2.6
-49.7 percent change
Standard Error 5.1
-51.4 percent change
Standard Error 2.6
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 141
-0.2 percent change
Standard Error 4.9
—
—
-57.2 percent change
Standard Error 2.6
-50.7 percent change
Standard Error 6.9
-52.9 percent change
Standard Error 3.8
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 169
3.1 percent change
Standard Error 4.3
—
-33.9 percent change
Standard Error 7.8
-52.9 percent change
Standard Error 2.5
-50.1 percent change
Standard Error 4.6
-53.7 percent change
Standard Error 2.9
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 197
8.6 percent change
Standard Error 5.8
—
—
—
-43.9 percent change
Standard Error 8.6
-52.5 percent change
Standard Error 2.7
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 225
4.6 percent change
Standard Error 3.0
—
19.5 percent change
-37.1 percent change
Standard Error 4.4
-35.1 percent change
Standard Error 8.5
-48.4 percent change
Standard Error 3.6
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 253
11.7 percent change
Standard Error 6.5
—
—
—
-31.9 percent change
Standard Error 9.7
-44.0 percent change
Standard Error 4.1
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 281
—
—
—
-10.7 percent change
Standard Error 6.1
—
—
Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)
Day 309
—
—
—
—
-21.0 percent change
Standard Error 14.7
-26.8 percent change
Standard Error 4.8

SECONDARY outcome

Timeframe: Baseline and day 2, 3, 5, 8, 15, 29, 57, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only)

Population: Treated participants with available data at each time point

Outcome measures

Outcome measures
Measure
Placebo
n=10 Participants
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
n=6 Participants
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 5
-3.9 percent change
Standard Error 6.0
47.6 percent change
Standard Error 12.2
51.8 percent change
Standard Error 17.9
114.2 percent change
Standard Error 27.2
103.1 percent change
Standard Error 41.8
262.1 percent change
Standard Error 61.9
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 8
-0.7 percent change
Standard Error 8.9
37.7 percent change
Standard Error 20.4
76.9 percent change
Standard Error 20.7
182.4 percent change
Standard Error 40.2
163.7 percent change
Standard Error 38.4
353.6 percent change
Standard Error 92.4
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 113
-1.2 percent change
Standard Error 10.2
3.9 percent change
Standard Error 15.4
29.5 percent change
Standard Error 32.8
38.5 percent change
Standard Error 13.5
46.5 percent change
Standard Error 10.5
155.7 percent change
Standard Error 44.5
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 141
-3.8 percent change
Standard Error 13.9
—
—
16.9 percent change
Standard Error 11.1
22.8 percent change
Standard Error 16.6
175.4 percent change
Standard Error 81.3
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 169
-7.9 percent change
Standard Error 5.3
—
-16.7 percent change
Standard Error 10.6
19.7 percent change
Standard Error 8.2
21.9 percent change
Standard Error 16.1
90.2 percent change
Standard Error 27.6
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 309
—
—
—
—
16.6 percent change
Standard Error 24.9
33.8 percent change
Standard Error 11.9
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 2
6.9 percent change
Standard Error 8.7
2.4 percent change
Standard Error 13.0
10.1 percent change
Standard Error 14.1
44.0 percent change
Standard Error 13.0
40.9 percent change
Standard Error 19.5
129.0 percent change
Standard Error 25.2
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 3
-8.2 percent change
Standard Error 6.1
28.9 percent change
Standard Error 9.7
15.0 percent change
Standard Error 18.8
71.7 percent change
Standard Error 15.8
60.7 percent change
Standard Error 21.7
146.1 percent change
Standard Error 46.0
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 15
11.2 percent change
Standard Error 8.9
91.5 percent change
Standard Error 8.2
117.3 percent change
Standard Error 33.4
146.4 percent change
Standard Error 29.0
109.4 percent change
Standard Error 36.3
203.2 percent change
Standard Error 27.2
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 29
5.1 percent change
Standard Error 7.7
97.2 percent change
Standard Error 23.8
110.9 percent change
Standard Error 40.7
99.2 percent change
Standard Error 16.8
70.4 percent change
Standard Error 28.3
215.2 percent change
Standard Error 79.4
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 57
5.3 percent change
Standard Error 8.3
64.6 percent change
Standard Error 18.4
120.5 percent change
Standard Error 35.5
98.0 percent change
Standard Error 17.9
90.9 percent change
Standard Error 20.8
177.0 percent change
Standard Error 36.8
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 85
17.1 percent change
Standard Error 10.2
11.9 percent change
Standard Error 9.6
36.6 percent change
Standard Error 24.5
76.9 percent change
Standard Error 20.2
64.4 percent change
Standard Error 18.4
170.5 percent change
Standard Error 40.8
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 99
5.6 percent change
Standard Error 7.4
19.9 percent change
Standard Error 10.5
46.4 percent change
Standard Error 31.1
79.6 percent change
Standard Error 13.9
44.0 percent change
Standard Error 10.9
178.5 percent change
Standard Error 93.3
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 197
-14.9 percent change
Standard Error 5.4
—
—
—
17.0 percent change
Standard Error 9.8
100.7 percent change
Standard Error 42.1
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 225
-5.1 percent change
Standard Error 14.1
—
15.9 percent change
-30.9 percent change
Standard Error 5.0
6.2 percent change
Standard Error 12.3
151.4 percent change
Standard Error 83.5
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 253
8.5 percent change
Standard Error 12.6
—
—
—
10.9 percent change
Standard Error 18.1
70.8 percent change
Standard Error 31.5
Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)
Day 281
—
—
—
-26.1 percent change
Standard Error 9.4
—
—

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Denosumab 0.03 mg/kg

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

Denosumab 0.1 mg/kg

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

Denosumab 0.3 mg/kg

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

Denosumab 1.0 mg/kg

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Denosumab 3.0 mg/kg

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

Denosumab Total

Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=10 participants at risk
Participants received a single subcutaneous injection of placebo to denosumab on day 1.
Denosumab 0.03 mg/kg
n=6 participants at risk
Participants received a single subcutaneous injection of 0.03 mg/kg denosumab on day 1.
Denosumab 0.1 mg/kg
n=6 participants at risk
Participants received a single subcutaneous injection of 0.1 mg/kg denosumab on day 1.
Denosumab 0.3 mg/kg
n=6 participants at risk
Participants received a single subcutaneous injection of 0.3 mg/kg denosumab on day 1.
Denosumab 1.0 mg/kg
n=6 participants at risk
Participants received a single subcutaneous injection of 1.0 mg/kg denosumab on day 1.
Denosumab 3.0 mg/kg
n=6 participants at risk
Participants received a single subcutaneous injection of 3.0 mg/kg denosumab on day 1.
Denosumab Total
n=30 participants at risk
All participants received a single subcutaneous injection of denosumab on day 1.
Cardiac disorders
ATRIAL FIBRILLATION
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders
SENSATION OF BLOCK IN EAR
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders
TINNITUS
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders
BLEPHAROSPASM
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders
CONJUNCTIVITIS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
ABDOMINAL PAIN
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
CHEILITIS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
DIARRHOEA
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
GASTRITIS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
GINGIVAL BLEEDING
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
LIP BLISTER
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
STOMACH DISCOMFORT
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders
STOMATITIS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
CHEST DISCOMFORT
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
CHEST PAIN
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
FATIGUE
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
INJECTION SITE ERYTHEMA
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
INJECTION SITE HAEMORRHAGE
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
INJECTION SITE PAIN
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
33.3%
2/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
10.0%
3/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders
MALAISE
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders
SEASONAL ALLERGY
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations
BRONCHITIS ACUTE
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations
HERPES ZOSTER
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations
NASOPHARYNGITIS
30.0%
3/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
33.3%
2/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
83.3%
5/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
30.0%
9/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations
PERIODONTAL INFECTION
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications
BLISTER
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications
CONTUSION
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications
THERMAL BURN
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations
HEPATIC ENZYME INCREASED
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders
ARTHRALGIA
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders
BACK PAIN
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders
MUSCLE FATIGUE
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders
MYALGIA
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders
SPONDYLOSIS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders
DIZZINESS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders
HEADACHE
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders
HYPOAESTHESIA
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
33.3%
2/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
10.0%
3/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders
DERMATITIS
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders
ECZEMA
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
6.7%
2/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders
HAEMORRHAGE SUBCUTANEOUS
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders
PRURITUS
10.0%
1/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders
RASH
0.00%
0/10 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
16.7%
1/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
0.00%
0/6 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
3.3%
1/30 • From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

  • Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
  • Publication restrictions are in place

Restriction type: OTHER