Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals (NCT NCT02958982)
NCT ID: NCT02958982
Last Updated: 2019-10-04
Results Overview
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Baseline through 2 weeks
Results posted on
2019-10-04
Participant Flow
Participants were recruited between 03 Nov 2016 to 05 Apr 2017 for Single Ascending Dose (SAD) study and patients were recruited between 12 May 2017 to 26 Aug 2017 for Multiple Ascending Dose (MAD) study
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo (SAD and MAD). The proof of concept study was terminated prematurely after enrolling only one patient. Therefore, no analysis was performed.
Participant milestones
| Measure |
Pooled Placebo (SAD)
Placebo
Placebo: Participants will receive single oral dose of RP3128 in SAD,
|
RP3128_25 mg_SAD
Participants will receive single oral dose of 25 mg of RP3128 once a day in SAD
|
RP3128_50 mg_SAD
Participants will receive single oral dose of 50 mg of RP3128 once a day in SAD
|
RP3128_100 mg_SAD
Participants will receive single oral dose of 100 mg of RP3128 once a day in SAD
|
RP3128_200 mg_SAD
Participants will receive single oral dose of 200 mg of RP3128 once a day in SAD
|
RP3128_400 mg_SAD
Participants will receive single oral dose of 400 mg of RP3128 once a day in SAD
|
Pooled Placebo (MAD)
Placebo
Placebo: Participants will receive single oral dose of RP3128 in MAD,
|
RP3128_25 mg_MAD
Participants will receive multiple oral dose of 25 mg of RP3128 for a week in MAD,
|
RP3128_100 mg_MAD
Participants will receive multiple oral dose of 100 mg of RP3128 for a week in MAD,
|
RP3128_400 mg_MAD
Participants will receive multiple oral dose of 400 mg of RP3128 for a week in MAD,
|
Proof of Concept
RP3128/Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: 25 mg in SAD Study
STARTED
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1: 25 mg in SAD Study
COMPLETED
|
1
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1: 25 mg in SAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2: 50 mg in SAD Study
STARTED
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2: 50 mg in SAD Study
COMPLETED
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2: 50 mg in SAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3: 100 mg in SAD Study
STARTED
|
2
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3: 100 mg in SAD Study
COMPLETED
|
2
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3: 100 mg in SAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4: 200 mg in SAD Study
STARTED
|
2
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4: 200 mg in SAD Study
COMPLETED
|
2
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4: 200 mg in SAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 5: 400 mg in SAD Study
STARTED
|
2
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 5: 400 mg in SAD Study
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 5: 400 mg in SAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1 : 25 mg in MAD Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
6
|
0
|
0
|
0
|
|
Cohort 1 : 25 mg in MAD Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
6
|
0
|
0
|
0
|
|
Cohort 1 : 25 mg in MAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2: 100 mg in MAD Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
6
|
0
|
0
|
|
Cohort 2: 100 mg in MAD Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
6
|
0
|
0
|
|
Cohort 2: 100 mg in MAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3: 400 mg in MAD Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
6
|
0
|
|
Cohort 3: 400 mg in MAD Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
6
|
0
|
|
Cohort 3: 400 mg in MAD Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Proof of Concept Study
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Proof of Concept Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Proof of Concept Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals
Baseline characteristics by cohort
| Measure |
Pooled Placebo (SAD)
n=9 Participants
Placebo: Participants will receive single oral dose of Placebo in SAD
|
RP3128_25 mg_SAD
n=3 Participants
RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
|
RP3128_50 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
|
RP3128_100 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
|
RP3128_200 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
|
RP3128_400 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
|
Pooled Placebo
n=6 Participants
Placebo: Participants will receive multiple oral doses of placebo in MAD
|
RP3128_25 mg_MAD
n=6 Participants
RP3128: Participants will receive multiple oral dose of 25 mg of RP3128 in MAD
|
RP3128_100 mg_MAD
n=6 Participants
RP3128: Participants will receive multiple oral dose of 100 mg of RP3128 in MAD
|
RP3128_400 mg_MAD
n=6 Participants
RP3128: Participants will receive multiple oral dose of 400 mg of RP3128 in MAD
|
Proof of Concept
n=1 Participants
Patient received at least one dose of RP3128/placebo
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
56 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
29.4 Years
STANDARD_DEVIATION 8.26 • n=5 Participants
|
36.3 Years
STANDARD_DEVIATION 4.93 • n=7 Participants
|
36.3 Years
STANDARD_DEVIATION 9.07 • n=5 Participants
|
31.5 Years
STANDARD_DEVIATION 6.61 • n=4 Participants
|
38.2 Years
STANDARD_DEVIATION 8.30 • n=21 Participants
|
34.7 Years
STANDARD_DEVIATION 9.42 • n=10 Participants
|
36.7 Years
STANDARD_DEVIATION 4.59 • n=115 Participants
|
29.5 Years
STANDARD_DEVIATION 6.92 • n=24 Participants
|
33.2 Years
STANDARD_DEVIATION 3.43 • n=42 Participants
|
36.5 Years
STANDARD_DEVIATION 5.39 • n=42 Participants
|
32.0 Years
STANDARD_DEVIATION 0 • n=42 Participants
|
33.6 Years
STANDARD_DEVIATION 7.32 • n=42 Participants
|
|
Sex: Female, Male
Female
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
57 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
41 Participants
n=42 Participants
|
|
Ethnicity (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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 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=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
6 participants
n=24 Participants
|
6 participants
n=42 Participants
|
6 participants
n=42 Participants
|
1 participants
n=42 Participants
|
57 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline through 2 weeksPopulation: There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Outcome measures
| Measure |
Pooled Placebo (SAD)
n=9 Participants
Placebo: Participants will receive single oral dose of RP3128 in SAD,
|
RP3128_25 mg_SAD
n=3 Participants
RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
|
RP3128_50 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
|
RP3128_100 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
|
RP3128_200 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
|
RP3128_400 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
|
Pooled Placebo (MAD)
n=6 Participants
Placebo: Participants will receive single oral dose of RP3128 in MAD,
|
RP3128_25 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD,
|
RP3128_100 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD study
|
RP3128_400 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD study
|
Proof of Concept
n=1 Participants
Patient received at least one dose of RP3128/Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose through 48 hours post doseCmax after administration of RP3128/ placebo in part 1 and part 2
Outcome measures
| Measure |
Pooled Placebo (SAD)
n=9 Participants
Placebo: Participants will receive single oral dose of RP3128 in SAD,
|
RP3128_25 mg_SAD
n=3 Participants
RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
|
RP3128_50 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
|
RP3128_100 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
|
RP3128_200 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
|
RP3128_400 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
|
Pooled Placebo (MAD)
n=6 Participants
Placebo: Participants will receive single oral dose of RP3128 in MAD,
|
RP3128_25 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD,
|
RP3128_100 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD study
|
RP3128_400 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD study
|
Proof of Concept
n=1 Participants
Patient received at least one dose of RP3128/Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax)
|
0 micrograms/mL
Standard Deviation 0
|
0.171 micrograms/mL
Standard Deviation 0.041
|
0.305 micrograms/mL
Standard Deviation 0.075
|
0.561 micrograms/mL
Standard Deviation 0.12
|
0.64 micrograms/mL
Standard Deviation 0.29
|
0.915 micrograms/mL
Standard Deviation 0.41
|
0 micrograms/mL
Standard Deviation 0
|
0.533 micrograms/mL
Standard Deviation 0.10
|
2.034 micrograms/mL
Standard Deviation 1.11
|
3.95 micrograms/mL
Standard Deviation 2.16
|
0 micrograms/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Predose and Day 7 in Part 2Levels of cytokines following LPS (lipopolysaccharide) or CD3/CD28 stimulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prechallenge to 3, 8 and 24 hours post challenge in Part 3Change in FeNo after administration of RP3128/ placebo in part 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3AUEC0-3h, AUEC3-8h after administration of RP3128/ placebo in part 3
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 and 24 hours post allergen challenge in Part 3Absolute and % counts of sputum eosinophils and neutrophils
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose through 48 hours post doseAUC0-t after administration of RP3128/ placebo in part 1 and part 2
Outcome measures
| Measure |
Pooled Placebo (SAD)
n=9 Participants
Placebo: Participants will receive single oral dose of RP3128 in SAD,
|
RP3128_25 mg_SAD
n=3 Participants
RP3128: Participants will receive single oral dose of 25 mg of RP3128 in SAD
|
RP3128_50 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 50 mg of RP3128 in SAD
|
RP3128_100 mg_SAD
n=4 Participants
RP3128: Participants will receive single oral dose of 100 mg of RP3128 in SAD
|
RP3128_200 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 200 mg of RP3128 in SAD
|
RP3128_400 mg_SAD
n=6 Participants
RP3128: Participants will receive single oral dose of 400 mg of RP3128 in SAD
|
Pooled Placebo (MAD)
n=6 Participants
Placebo: Participants will receive single oral dose of RP3128 in MAD,
|
RP3128_25 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 25 mg of RP3128 in MAD,
|
RP3128_100 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 100 mg of RP3128 in MAD study
|
RP3128_400 mg_MAD
n=6 Participants
RP3128 (MAD): Participants will receive multiple oral dose of 400 mg of RP3128 in MAD study
|
Proof of Concept
n=1 Participants
Patient received at least one dose of RP3128/Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma-Concentration
|
0 micrograms*hours/mL
Standard Deviation 0
|
8.821 micrograms*hours/mL
Standard Deviation 0.47
|
10.766 micrograms*hours/mL
Standard Deviation 3.884
|
30.340 micrograms*hours/mL
Standard Deviation 9.968
|
37.011 micrograms*hours/mL
Standard Deviation 14.56
|
94.227 micrograms*hours/mL
Standard Deviation 39.29
|
0 micrograms*hours/mL
Standard Deviation 0
|
7.934 micrograms*hours/mL
Standard Deviation 1.23
|
31.034 micrograms*hours/mL
Standard Deviation 19.71
|
61.821 micrograms*hours/mL
Standard Deviation 39.023
|
0 micrograms*hours/mL
Standard Deviation 0
|
Adverse Events
Pooled Placebo (SAD)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
RP3128_25 mg_SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RP3128_50 mg_SAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RP3128_100 mg_SAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
RP3128_200 mg_SAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
RP3128_400 mg_SAD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Pooled Placebo (MAD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
RP3128_25 mg_MAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RP3128_100 mg_MAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RP3128_400 mg_MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Proof of Concept
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pooled Placebo (SAD)
n=9 participants at risk
Placebo: Participants will receive single oral dose of RP3128 in SAD,
|
RP3128_25 mg_SAD
n=3 participants at risk
RP3128: Participants will receive single oral dose 25 mg of RP3128 in SAD
|
RP3128_50 mg_SAD
n=4 participants at risk
RP3128: Participants will receive single oral dose 50 mg of RP3128 in SAD
|
RP3128_100 mg_SAD
n=4 participants at risk
RP3128: Participants will receive single oral dose 100 mg of RP3128 in SAD
|
RP3128_200 mg_SAD
n=6 participants at risk
RP3128: Participants will receive single oral dose 200 mg of RP3128 in SAD
|
RP3128_400 mg_SAD
n=6 participants at risk
RP3128: Participants will receive single oral dose 400 mg of RP3128 in SAD
|
Pooled Placebo (MAD)
n=6 participants at risk
Placebo: Participants will receive single oral dose of RP3128 in MAD,
|
RP3128_25 mg_MAD
n=6 participants at risk
RP3128 (MAD): Participants will receive multiple oral dose 25 mg of RP3128 for one week in MAD,
|
RP3128_100 mg_MAD
n=6 participants at risk
RP3128 (MAD): Participants will receive multiple oral dose 100 mg of RP3128 for one week in MAD,
|
RP3128_400 mg_MAD
n=6 participants at risk
RP3128 (MAD): Participants will receive multiple oral dose 400 mg of RP3128 for one week in MAD,
|
Proof of Concept
n=1 participants at risk
Participants will receive RP3128/Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
General disorders
|
0.00%
0/9 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
50.0%
2/4 • Number of events 5 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Eye disorders
Eye Disorders
|
0.00%
0/9 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
25.0%
1/4 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
11.1%
1/9 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
33.3%
2/6 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
33.3%
2/6 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Infections and infestations
Infections and infestations
|
11.1%
1/9 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/9 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Investigations
Investigations
|
22.2%
2/9 • Number of events 3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
33.3%
1/3 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/9 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
33.3%
2/6 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
22.2%
2/9 • Number of events 3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Nervous system disorders
Nervous system disorders
|
11.1%
1/9 • Number of events 3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
25.0%
1/4 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
50.0%
2/4 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
33.3%
2/6 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Psychiatric disorders
Psychiatric disorders
|
0.00%
0/9 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
25.0%
1/4 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Renal and urinary disorders
Renal and urinary disorders
|
11.1%
1/9 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
11.1%
1/9 • Number of events 2 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/4 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
50.0%
2/4 • Number of events 3 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
16.7%
1/6 • Number of events 1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/6 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
0.00%
0/1 • 15 Days
There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place