Trial Outcomes & Findings for A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects (NCT NCT01052493)
NCT ID: NCT01052493
Last Updated: 2021-02-12
Results Overview
Number of subjects with adverse events recorded through the trial period
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
7-12 weeks
Results posted on
2021-02-12
Participant Flow
Recruitment at Sir John McMichael Centre, Hammersmith Hospital
12 participants started the study. It was a sequential cross-over study. They were randomised to receive either PP 1420 or placebo at each treatment stage. After the first treatment period, one volunteer withdrew. This participant was replaced with a new participant in order that 12 participants progressed onto intervention periods 2 and then 3.
Participant milestones
| Measure |
Placebo, 4mg PP 1420, 8mg PP 1420
Intervention Period 1: Placebo Intervention period 2: 4mg PP 1420 Intervention period 3: 8mg PP 1420
|
2mg PP 1420, Placebo, 8mg PP 1420
Intervention Period 1: 2mg PP 1420 Intervention Period 2. Placebo Intervention Period 3. 8mg PP 1420
|
2mg PP 1420, 4mg PP 1420, Placebo
Intervention Period 1: 2mg PP 1420 Intervention Period 2. 4mg PP 1420 Intervention Period 3. Placebo
|
|---|---|---|---|
|
Intervention 1 (Up to 10 Days)
STARTED
|
4
|
4
|
4
|
|
Intervention 1 (Up to 10 Days)
COMPLETED
|
3
|
4
|
4
|
|
Intervention 1 (Up to 10 Days)
NOT COMPLETED
|
1
|
0
|
0
|
|
Washout Period 1 (up to 5 Days)
STARTED
|
3
|
4
|
4
|
|
Washout Period 1 (up to 5 Days)
COMPLETED
|
3
|
4
|
4
|
|
Washout Period 1 (up to 5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention 2 (up to 10 Days)
STARTED
|
4
|
4
|
4
|
|
Intervention 2 (up to 10 Days)
COMPLETED
|
4
|
4
|
4
|
|
Intervention 2 (up to 10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 2 (up to 5 Days)
STARTED
|
4
|
4
|
4
|
|
Washout Period 2 (up to 5 Days)
COMPLETED
|
4
|
4
|
4
|
|
Washout Period 2 (up to 5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention 3 (up to 10 Days)
STARTED
|
4
|
4
|
4
|
|
Intervention 3 (up to 10 Days)
COMPLETED
|
4
|
4
|
4
|
|
Intervention 3 (up to 10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo, 4mg PP 1420, 8mg PP 1420
Intervention Period 1: Placebo Intervention period 2: 4mg PP 1420 Intervention period 3: 8mg PP 1420
|
2mg PP 1420, Placebo, 8mg PP 1420
Intervention Period 1: 2mg PP 1420 Intervention Period 2. Placebo Intervention Period 3. 8mg PP 1420
|
2mg PP 1420, 4mg PP 1420, Placebo
Intervention Period 1: 2mg PP 1420 Intervention Period 2. 4mg PP 1420 Intervention Period 3. Placebo
|
|---|---|---|---|
|
Intervention 1 (Up to 10 Days)
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A First-Time-in-Human Study to Assess the Safety and Tolerability of PP 1420 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
All Participant
n=12 Participants
Crossover, sequential study with all participant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-12 weeksNumber of subjects with adverse events recorded through the trial period
Outcome measures
| Measure |
2mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
4mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
8mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
Placebo
n=12 Participants
0.9% saline
|
|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs)
Total number of AEs
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
TEAEs leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events (AEs)
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: PP 1420 arms only
The area under the concentration vs. time curve of PP 1420 from time zero to the last sampling time, calculated by the linear trapezoidal rule
Outcome measures
| Measure |
2mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
4mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
8mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
Placebo
0.9% saline
|
|---|---|---|---|---|
|
AUC0-t(Last)
|
93.6 ng ml-1 h
Interval 49.7 to 126.0
|
229 ng ml-1 h
Interval 107.0 to 316.0
|
403 ng ml-1 h
Interval 205.0 to 589.0
|
—
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: PP 1420 arms only
the area under the concentration vs. time curve for PP 1420, estimated from time zero to infinity
Outcome measures
| Measure |
2mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
4mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
8mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
Placebo
0.9% saline
|
|---|---|---|---|---|
|
AUC0-∞
|
101 ng ml-1 h
Interval 67.6 to 131.0
|
241 ng ml-1 h
Interval 109.0 to 356.0
|
418 ng ml-1 h
Interval 210.0 to 600.0
|
—
|
SECONDARY outcome
Timeframe: Within 24 hoursPopulation: PP 1420 arms only
Outcome measures
| Measure |
2mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
4mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
8mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
Placebo
0.9% saline
|
|---|---|---|---|---|
|
Maximum Observed Plasma Drug Concentration (Cmax)
|
26.3 ng ml-1
Interval 15.9 to 39.1
|
55.1 ng ml-1
Interval 37.5 to 74.2
|
95.7 ng ml-1
Interval 74.2 to 126.0
|
—
|
SECONDARY outcome
Timeframe: Within 24 hoursPopulation: PP 1420 arms only
Outcome measures
| Measure |
2mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
4mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
8mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
Placebo
0.9% saline
|
|---|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax)
|
0.875 hours
Interval 0.32 to 2.0
|
1.00 hours
Interval 0.75 to 1.5
|
1.00 hours
Interval 0.5 to 1.5
|
—
|
SECONDARY outcome
Timeframe: Within 24 hoursPopulation: PP 1420 arms only
Calculated from log 2/λz where λz is the apparent terminal rate constant.
Outcome measures
| Measure |
2mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
4mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
8mg PP 1420
n=8 Participants
Single dose of PP 1420, administered subcutaneously
|
Placebo
0.9% saline
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t½)
|
2.42 hours
Interval 1.64 to 3.38
|
2.49 hours
Interval 1.69 to 3.6
|
2.61 hours
Interval 2.13 to 3.95
|
—
|
Adverse Events
2mg PP 1420
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
4mg PP 1420
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
8mg PP 1420
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2mg PP 1420
n=8 participants at risk
Single dose of PP 1420, administered subcutaneously.
|
4mg PP 1420
n=8 participants at risk
Single dose of PP 1420, administered subcutaneously.
|
8mg PP 1420
n=8 participants at risk
Single dose of PP 1420, administered subcutaneously.
|
Placebo
n=12 participants at risk
0.9% saline
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 2 • 7-12 weeks
|
25.0%
2/8 • Number of events 2 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
16.7%
2/12 • Number of events 2 • 7-12 weeks
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/bruising
|
0.00%
0/8 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
25.0%
2/8 • Number of events 2 • 7-12 weeks
|
0.00%
0/12 • 7-12 weeks
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
8.3%
1/12 • Number of events 1 • 7-12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
8.3%
1/12 • Number of events 1 • 7-12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
0.00%
0/12 • 7-12 weeks
|
|
Gastrointestinal disorders
Abdominal pain/bloating
|
0.00%
0/8 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
0.00%
0/12 • 7-12 weeks
|
|
Infections and infestations
Infected finger
|
0.00%
0/8 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
0.00%
0/12 • 7-12 weeks
|
|
Infections and infestations
Cold sore
|
0.00%
0/8 • 7-12 weeks
|
12.5%
1/8 • Number of events 1 • 7-12 weeks
|
0.00%
0/8 • 7-12 weeks
|
0.00%
0/12 • 7-12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place