Trial Outcomes & Findings for A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers (NCT NCT04901078)
NCT ID: NCT04901078
Last Updated: 2025-01-06
Results Overview
• Incidence of reported Treatment Emergent Adverse Events (TEAEs), related AEs, AEs leading to discontinuation, and AEs by severity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
From first dose of study drug up to 9 days for SAD cohorts and up to 16 days for MAD cohorts.
Results posted on
2025-01-06
Participant Flow
Participant milestones
| Measure |
SAD Cohort 1
Part A (SAD) cohort 1 was administered a single dose of 5mg KNX100 capsule.
|
SAD- Placebo Cohort
A matching number of placebo capsules were administered per cohort.
|
SAD Cohort 2
Part A (SAD) cohort 2 was administered a single dose of 3 x 5mg KNX100 capsules (15mg).
|
SAD Cohort 3
Part A (SAD) cohort 3 was administered a single dose of 25mg KNX100 capsule.
|
SAD Cohort 4
Part A (SAD) cohort 4 was administered a single dose of 2 X 25mg KNX100 capsules (50mg).
|
MAD Cohort 1
Part B(MAD) cohort 1 was administered of 2 x 5mg KNX100 capsules (10mg) once daily for 7 days.
|
MAD Cohort 2
Part B (MAD) cohort 2 was administered of 1 x 5mg and 1 x 25mg KNX100 capsules (30mg) once daily for 7 days.
|
MAD Cohort 3
Part B (MAD) cohort 3 was administered of 1 x 5mg and 1 x 25mg KNX100 capsules (30mg) twice daily for 7 days.
|
MAD-Placebo Cohort
A matching number of placebo capsules were administered for 7 days per cohort.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
8
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Study Investigating the Safety, Tolerability and Pharmacokinetics of KNX100 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
SAD Cohort 1
n=6 Participants
Part A (SAD) cohort 1 was administered a single dose of 5mg KNX100 capsule.
|
SAD Placebo Cohort
n=8 Participants
Part A (SAD) A single dose of a matching number of placebo capsules were administered per cohort.
|
SAD Cohort 2
n=6 Participants
Part A (SAD) cohort 2 was administered a single dose of 15mg (3 x 5mg) KNX100 capsules.
|
SAD Cohort 3
n=6 Participants
Part A (SAD) cohort 3 was administered a single dose of 25mg KNX100 capsule.
|
SAD Cohort 4
n=6 Participants
Part A (SAD) cohort 3 was administered a single dose of 50mg (2 x 25mg) KNX100 capsules.
|
MAD Placebo Cohort
n=6 Participants
Part B (MAD) A matching number of placebo capsules were administered either once or twice daily for 7 days.
|
MAD Cohort 1
n=6 Participants
Part B (MAD) cohort 1 was administered of 2 x 5mg KNX100 capsules (10mg) once daily for 7 days.
|
MAD Cohort 2
n=6 Participants
Part B (MAD) cohort 1 was administered of 1 x 5mg and 1x 25mg KNX100 capsules (30mg) once daily for 7 days.
|
MAD Cohort 3
n=6 Participants
Part B (MAD) cohort 1 was administered of 1 x 5mg and 1x 25mg KNX100 capsules (30mg) twice daily for 7 days.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
56 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 6.06 • n=99 Participants
|
27.6 years
STANDARD_DEVIATION 8.02 • n=107 Participants
|
29.8 years
STANDARD_DEVIATION 8.30 • n=206 Participants
|
27.5 years
STANDARD_DEVIATION 7.01 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 8.08 • n=31 Participants
|
32.2 years
STANDARD_DEVIATION 10.50 • n=30 Participants
|
31.7 years
STANDARD_DEVIATION 3.72 • n=3 Participants
|
28.3 years
STANDARD_DEVIATION 3.72 • n=6 Participants
|
27.7 years
STANDARD_DEVIATION 5.68 • n=114 Participants
|
29.7 years
STANDARD_DEVIATION 6.99
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Region of Enrollment
Australia
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
6 participants
n=30 Participants
|
6 participants
n=3 Participants
|
6 participants
n=6 Participants
|
6 participants
n=114 Participants
|
56 participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 9 days for SAD cohorts and up to 16 days for MAD cohorts.• Incidence of reported Treatment Emergent Adverse Events (TEAEs), related AEs, AEs leading to discontinuation, and AEs by severity.
Outcome measures
| Measure |
SAD Cohort 1
n=6 Participants
Part A (SAD) cohort 1 was administered a single dose of 5mg KNX100 capsule.
|
Placebo -SAD Cohort
n=8 Participants
A single dose of matching placebo capsules were administered per cohort.
|
SAD Cohort 2
n=6 Participants
Part A (SAD) cohort 2 was administered a single dose of 15mg (3 x 5mg) KNX100 capsules.
|
SAD Cohort 3
n=6 Participants
Part A (SAD) cohort 3 was administered a single dose of 25 mg KNX100 capsule.
|
SAD Cohort 4
n=6 Participants
Part A (SAD) cohort 4 was administered a single dose of 50mg (2 x 25mg) KNX100 capsules.
|
MAD Cohort 1
n=6 Participants
Part B (MAD) cohort 1 was administered of 2 x 5mg KNX100 capsules (10mg) once daily for 7 days.
|
MAD Cohort 2
n=6 Participants
Part B (MAD) cohort 2 was administered of 1 x 5mg and 1 x 25mg KNX100 capsules (30mg) once daily for 7 days.
|
MAD Cohort 3
n=6 Participants
Part B (MAD) cohort 3 was administered of 1 x 5mg and 1 x 25mg KNX100 capsules (30mg) twice daily for 7 days.
|
Placebo - MAD Cohort
n=6 Participants
Matching placebo capsules were administered once or twice daily per cohort.
|
|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants With TEAEs
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
SAD Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo SAD Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MAD Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
MAD Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MAD Cohort 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo MAD Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD Cohort 1
n=6 participants at risk
Part A (SAD) cohort 1 was administered a single dose of 5mg KNX100 capsule.
|
Placebo SAD Cohort
n=8 participants at risk
A single dose of matching placebo capsules were administered per cohort.
|
SAD Cohort 2
n=6 participants at risk
Part A (SAD) cohort 2 was administered a single dose of 15mg (3 x 5mg) KNX100 capsule.
|
SAD Cohort 3
n=6 participants at risk
Part A (SAD) cohort 3 was administered a single dose of 25mg KNX100 capsule.
|
SAD Cohort 4
n=6 participants at risk
Part A (SAD) cohort 4 was administered a single dose of 50mg (2 x 25mg) KNX100 capsule.
|
MAD Cohort 1
n=6 participants at risk
Part B (MAD) cohort 1 was administered of 2 x 5mg KNX100 capsules (10mg) once daily for 7 days.
|
MAD Cohort 2
n=6 participants at risk
Part B (MAD) cohort 2 was administered of 30mg (1 X 25mg + 1 x 5mg) KNX100 capsules once daily for 7 days.
|
MAD Cohort 3
n=6 participants at risk
Part B (MAD) cohort 2 was administered of 30mg (1 X 25mg + 1 x 5mg) KNX100 capsules twice daily for 7 days.
|
Placebo MAD Cohort
n=6 participants at risk
Matching placebo capsules were administered once or twice daily per cohort.
|
|---|---|---|---|---|---|---|---|---|---|
|
Social circumstances
somnolence
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
33.3%
2/6 • Number of events 2 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Fatique
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Nervous system disorders
headache
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
12.5%
1/8 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
33.3%
2/6 • Number of events 2 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
33.3%
2/6 • Number of events 2 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Application site dermatitis
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
33.3%
2/6 • Number of events 3 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Application site erythema
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Thirst
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/8 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
16.7%
1/6 • Number of events 1 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
0.00%
0/6 • Data collection for Adverse events were collected from the first dose for 24h hours to last dose in clinic, and up to 9 days for SAD cohorts, and up to 16 days for MAD cohorts.
Adverse events were grouped by system organ class (SOC) and preferred term (PT) and summarized by treatment. Treatment-emergent AEs were defined as any AE that started or worsened after the first dose of the study drug.
|
Additional Information
Director of Clinical Operations
Kinoxis Therapeutics Pty Ltd
Phone: +61434360596
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place