Trial Outcomes & Findings for A Safety and Tolerability Study of RJX Drug Product in Healthy Participants (NCT NCT03680105)
NCT ID: NCT03680105
Last Updated: 2020-04-27
Results Overview
Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
76 participants
Primary outcome timeframe
Up to Day 5 for Part 1 and Up to Day 12 for Part 2
Results posted on
2020-04-27
Participant Flow
Participants received either Rejuveinix (RJX) or saline placebo.
Participant milestones
| Measure |
Part 1; Cohort 1; RJX or Placebo
Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 2; RJX or Placebo
Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 3; RJX or Placebo
Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 4; RJX or Placebo
Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 5; RJX or Placebo
Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 6; RJX or Placebo
Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX or matching placebo on Day 1.
Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive.
|
Part 2; Cohort 1; RJX or Placebo
Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX or matching placebo every day for 7 days.
|
Part 2; Cohort 2; RJX or Placebo
Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX or matching placebo every day for 7 days.
|
Part 2; Cohort 3; RJX or Placebo
Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX or matching placebo every day for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
12
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
12
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1; Cohort 1; RJX or Placebo
n=8 Participants
Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 2; RJX or Placebo
n=8 Participants
Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 3; RJX or Placebo
n=8 Participants
Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 4; RJX or Placebo
n=8 Participants
Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 5; RJX or Placebo
n=8 Participants
Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 6; RJX or Placebo
n=12 Participants
Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX or matching placebo on Day 1.
Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive.
|
Part 2; Cohort 1; RJX or Placebo
n=8 Participants
Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX or matching placebo every day for 7 days.
|
Part 2; Cohort 2; RJX or Placebo
n=8 Participants
Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX or matching placebo every day for 7 days.
|
Part 2; Cohort 3; RJX or Placebo
n=8 Participants
Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX or matching placebo every day for 7 days.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
76 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
28 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
47 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
12 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=24 Participants
|
8 participants
n=42 Participants
|
76 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Day 5 for Part 1 and Up to Day 12 for Part 2Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03
Outcome measures
| Measure |
Part 1; Cohort 4; RJX
n=6 Participants
Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 5; RJX
n=6 Participants
Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 6; RJX
n=9 Participants
Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX Day 1.
Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive.
|
Part 2; Placebo
n=6 Participants
Participants in Part 2 received a dose of saline placebo every day for 7 days.
|
Part 2; Cohort 1; RJX
n=6 Participants
Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 2; RJX
n=6 Participants
Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 3; RJX
n=6 Participants
Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days.
|
Part 1; Placebo
n=13 Participants
Participants in Part 1 received a single saline placebo on Day 1.
|
Part 1; Cohort 1; RJX
n=6 Participants
Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 2; RJX
n=6 Participants
Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 3; RJX
n=6 Participants
Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Mild TEAE · With TEAE
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Mild TEAE · Without TEAE
|
4 Participants
|
4 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
11 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Moderate TEAE · With TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Moderate TEAE · Without TEAE
|
5 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
13 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Severe TEAE · With TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Severe TEAE · Without TEAE
|
6 Participants
|
6 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
13 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Related TEAE · With TEAE
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Treatment-related Adverse Events (TEAE) Reporting of RJX
Related TEAE · Without TEAE
|
4 Participants
|
4 Participants
|
9 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
13 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Day 2 for Part 1 and Up to Day 8 for Part 2Population: Counts of 12-lead safety ECG interpretations across Intent to Treat (ITT) population showed no notable changes when compared to baseline for either study part.
Number of participants with abnormal and clinically significant findings based on ECG.
Outcome measures
| Measure |
Part 1; Cohort 4; RJX
n=6 Participants
Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 5; RJX
n=6 Participants
Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 6; RJX
n=9 Participants
Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX Day 1.
Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive.
|
Part 2; Placebo
n=6 Participants
Participants in Part 2 received a dose of saline placebo every day for 7 days.
|
Part 2; Cohort 1; RJX
n=6 Participants
Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 2; RJX
n=6 Participants
Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 3; RJX
n=6 Participants
Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days.
|
Part 1; Placebo
n=13 Participants
Participants in Part 1 received a single saline placebo on Day 1.
|
Part 1; Cohort 1; RJX
n=6 Participants
Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 2; RJX
n=6 Participants
Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 3; RJX
n=6 Participants
Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of RJX as Assessed by Electrocardiograms (ECGs).
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 5 for Part 1 and Up to Day 12 for Part 2Population: Analysis based on Intent to Treat (ITT) population across Part 1 and Part 2, all cohorts. Only 1 subject, one incidence, for the study; presented on Day 12, Principal Investigator considered clinically significant and a mild TEAE considered unlikely related to RJX.
Number of participants with clinically significant values and actual changes from baseline of continuous neurological assessments.
Outcome measures
| Measure |
Part 1; Cohort 4; RJX
n=6 Participants
Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 5; RJX
n=6 Participants
Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 6; RJX
n=9 Participants
Participants in Part 1; Cohort 6 received a single dose of 0.500 mL/kg RJX Day 1.
Cohort 6 subjects comprised a cohort of healthy volunteers aged 51-70 inclusive.
|
Part 2; Placebo
n=6 Participants
Participants in Part 2 received a dose of saline placebo every day for 7 days.
|
Part 2; Cohort 1; RJX
n=6 Participants
Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 2; RJX
n=6 Participants
Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 3; RJX
n=6 Participants
Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days.
|
Part 1; Placebo
n=13 Participants
Participants in Part 1 received a single saline placebo on Day 1.
|
Part 1; Cohort 1; RJX
n=6 Participants
Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX or matching placebo on Day 1.
|
Part 1; Cohort 2; RJX
n=6 Participants
Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 3; RJX
n=6 Participants
Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability of RJX as Assessed by Neurological Examinations.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part 1; Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1; Cohort 1; RJX
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1; Cohort 2; RJX
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1; Cohort 3; RJX
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1; Cohort 4; RJX
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1; Cohort 5; RJX
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1; Cohort 6; RJX
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2; Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2; Cohort 1; RJX
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2; Cohort 2; RJX or Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2; Cohort 3; RJX or Placebo
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 |
Part 1; Placebo
n=13 participants at risk
Participants in Part 1 received a single saline placebo on Day 1.
|
Part 1; Cohort 1; RJX
n=6 participants at risk
Participants in Part 1; Cohort 1 received a single 0.024 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 2; RJX
n=6 participants at risk
Participants in Part 1; Cohort 2 received a single 0.076 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 3; RJX
n=6 participants at risk
Participants in Part 1; Cohort 3 received a single 0.240 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 4; RJX
n=6 participants at risk
Participants in Part 1; Cohort 4 received a single 0.500 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 5; RJX
n=6 participants at risk
Participants in Part 1; Cohort 5 received a single 0.759 mL/kg dose of RJX on Day 1.
|
Part 1; Cohort 6; RJX
n=9 participants at risk
Participants in Part 1; Cohort 6 receive a single dose of 0.500 mL/kg RJX on Day 1.
Cohort 6 subjects comprised a cohort of healthy volunteers aged 50-70 inclusive.
|
Part 2; Placebo
n=6 participants at risk
Participants in Part 2 received a saline placebo every day for 7 days.
|
Part 2; Cohort 1; RJX
n=6 participants at risk
Participants in Part 2; Cohort 1 received a dose of 0.240 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 2; RJX or Placebo
n=6 participants at risk
Participants in Part 2; Cohort 2 received a dose of 0.500 mL/kg RJX every day for 7 days.
|
Part 2; Cohort 3; RJX or Placebo
n=6 participants at risk
Participants in Part 2; Cohort 3 received a dose of 0.759 mL/kg RJX every day for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Infusion site discomfort
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
General disorders
Infusion Site Pain
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 2 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
General disorders
Infusion Site Reaction
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
33.3%
2/6 • Number of events 2 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Nervous system disorders
Delayed Sleep Phase
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Nervous system disorders
Clonus
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Investigations
Blood Pressure Systolic Decreased
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Blood and lymphatic system disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Investigations
C-reactive Protein Increased
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/13 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/9 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
0.00%
0/6 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
16.7%
1/6 • Number of events 1 • Part 1 (SAD): 5 Days Part 2 (MAD) 12 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place