Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects (NCT NCT02667639)
NCT ID: NCT02667639
Last Updated: 2021-12-28
Results Overview
Number of participants with study drug related adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
Until 60 days after administration
Results posted on
2021-12-28
Participant Flow
Participant milestones
| Measure |
Treatment
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
10
|
|
Overall Study
COMPLETED
|
25
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-35
|
25 participants
n=25 Participants
|
10 participants
n=10 Participants
|
10 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=25 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=25 Participants
|
9 Participants
n=10 Participants
|
32 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
25 Participants
n=25 Participants
|
10 Participants
n=10 Participants
|
35 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Until 60 days after administrationNumber of participants with study drug related adverse events
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Adverse Events
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Until 60 days after administrationNumber of Participants with Study Drug Related Serious Adverse Events
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Serious Adverse Events
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until 30 days after administrationPercentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Respiratory Rate
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Until 30 days after administrationPercentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Blood Pressure
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Until 30 days after administrationPercentage of participants with abnormal oxygen saturation. Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Oxygen Saturation
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Until 30 days after administrationPercentage of participants with abnormal body temperature. Among adults, the average body temperature ranges from 97°F (36.1°C) to 99°F (37.2°C).
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Body Temperature
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Until 30 days after administrationPercentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used.
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Clinical Laboratory Tests
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30Mean AUC 0-t (area under the concentration- time curve from time zero to day 30)
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
RPH-104 - Area Under the Curve (AUC)
4 mg
|
74500 hr*ng/mL
Standard Deviation 24700
|
0 hr*ng/mL
Standard Deviation 0
|
|
RPH-104 - Area Under the Curve (AUC)
20 mg
|
430000 hr*ng/mL
Standard Deviation 95700
|
0 hr*ng/mL
Standard Deviation 0
|
|
RPH-104 - Area Under the Curve (AUC)
40 mg
|
661000 hr*ng/mL
Standard Deviation 158000
|
0 hr*ng/mL
Standard Deviation 0
|
|
RPH-104 - Area Under the Curve (AUC)
80 mg
|
1610000 hr*ng/mL
Standard Deviation 317000
|
0 hr*ng/mL
Standard Deviation 0
|
|
RPH-104 - Area Under the Curve (AUC)
160 mg
|
3390000 hr*ng/mL
Standard Deviation 1450000
|
0 hr*ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30Median Tmax. Definition of Tmax is time at which Cmax occurs.
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
RPH-104 - Time to Maximum Concentration (Tmax)
4 mg
|
96 hr
Interval 94.4 to 192.0
|
0 hr
Interval 0.0 to 0.0
|
|
RPH-104 - Time to Maximum Concentration (Tmax)
20 mg
|
96 hr
Interval 48.0 to 96.2
|
0 hr
Interval 0.0 to 0.0
|
|
RPH-104 - Time to Maximum Concentration (Tmax)
40 mg
|
120 hr
Interval 96.0 to 192.0
|
0 hr
Interval 0.0 to 0.0
|
|
RPH-104 - Time to Maximum Concentration (Tmax)
80 mg
|
96 hr
Interval 72.0 to 120.0
|
0 hr
Interval 0.0 to 0.0
|
|
RPH-104 - Time to Maximum Concentration (Tmax)
160 mg
|
120 hr
Interval 72.0 to 120.0
|
0 hr
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30Mean t½. Definition of t½ is terminal elimination half-life.
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
RPH-104 - Elimination Half-life (t1/2)
4 mg
|
245 hr
Standard Deviation 9.50
|
0 hr
Standard Deviation 0
|
|
RPH-104 - Elimination Half-life (t1/2)
20 mg
|
249 hr
Standard Deviation 6.08
|
0 hr
Standard Deviation 0
|
|
RPH-104 - Elimination Half-life (t1/2)
40 mg
|
255 hr
Standard Deviation 43.1
|
0 hr
Standard Deviation 0
|
|
RPH-104 - Elimination Half-life (t1/2)
80 mg
|
235 hr
Standard Deviation 22.8
|
0 hr
Standard Deviation 0
|
|
RPH-104 - Elimination Half-life (t1/2)
160 mg
|
243 hr
Standard Deviation 40.4
|
0 hr
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30Mean Cmax. Highest concentration determined in the measuring interval.
Outcome measures
| Measure |
Treatment
n=25 Participants
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 Participants
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
RPH-104 - Maximum Plasma Concentration (Cmax)
4 mg
|
198 ng/mL
Standard Deviation 89.1
|
0 ng/mL
Standard Deviation 0
|
|
RPH-104 - Maximum Plasma Concentration (Cmax)
20 mg
|
1280 ng/mL
Standard Deviation 402
|
0 ng/mL
Standard Deviation 0
|
|
RPH-104 - Maximum Plasma Concentration (Cmax)
40 mg
|
1650 ng/mL
Standard Deviation 257
|
0 ng/mL
Standard Deviation 0
|
|
RPH-104 - Maximum Plasma Concentration (Cmax)
80 mg
|
5120 ng/mL
Standard Deviation 1410
|
0 ng/mL
Standard Deviation 0
|
|
RPH-104 - Maximum Plasma Concentration (Cmax)
160 mg
|
10300 ng/mL
Standard Deviation 4470
|
0 ng/mL
Standard Deviation 0
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=25 participants at risk
A single dose of RPH-104 (4, 20, 40, 80 or 160 mg) is administered subcutaneously.
RPH-104
|
Placebo
n=10 participants at risk
A single 0.9% sodium chloride injection is administered subcutaneously.
Sodium chloride Sterile Injection 0.9% w/v
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
32.0%
8/25 • 60 days
|
40.0%
4/10 • 60 days
|
|
Nervous system disorders
Nervous system disorders
|
52.0%
13/25 • 60 days
|
40.0%
4/10 • 60 days
|
|
Infections and infestations
Infections and infestations
|
24.0%
6/25 • 60 days
|
30.0%
3/10 • 60 days
|
|
General disorders
General disorders and administration site conditions
|
12.0%
3/25 • 60 days
|
20.0%
2/10 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
8.0%
2/25 • 60 days
|
20.0%
2/10 • 60 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
8.0%
2/25 • 60 days
|
0.00%
0/10 • 60 days
|
|
Investigations
Investigations
|
8.0%
2/25 • 60 days
|
0.00%
0/10 • 60 days
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
4.0%
1/25 • 60 days
|
10.0%
1/10 • 60 days
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/25 • 60 days
|
10.0%
1/10 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
4.0%
1/25 • 60 days
|
0.00%
0/10 • 60 days
|
|
Psychiatric disorders
Psychiatric disorders
|
4.0%
1/25 • 60 days
|
0.00%
0/10 • 60 days
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.00%
0/25 • 60 days
|
10.0%
1/10 • 60 days
|
|
Renal and urinary disorders
Pollakiuria
|
8.0%
2/25 • 60 days
|
0.00%
0/10 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place