Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316 (NCT NCT02041221)
NCT ID: NCT02041221
Last Updated: 2016-05-23
Results Overview
The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Two (2) Weeks
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
S0597 Dose 1
Subjects will be administered with SPARC1316 dose 1
|
S0597 Dose 2
Subjects will receive SPARC1316 dose 2
|
S0597 Dose 3
Subjects will receive SPARC1316 dose 3
|
S0597 Dose 4
Subjects will receive SPARC1316 dose 4
|
S0597 Dose 5
Subjects will receive SPARC1316 dose 5
|
Placebo
Subjects will receive placebo
|
|---|---|---|---|---|---|---|
|
Part 1
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Part 1
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
10
|
|
Part 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2
STARTED
|
6
|
6
|
6
|
0
|
0
|
6
|
|
Part 2
COMPLETED
|
6
|
6
|
5
|
0
|
0
|
6
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Baseline characteristics by cohort
| Measure |
S0597 Dose 1
n=6 Participants
Subjects will be administered with S0597
S0597: The subjects will receive S0597.
Placebo
|
S0597 Dose 2
n=6 Participants
The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo
|
S0597 Dose 3
n=6 Participants
|
S0597 Dose 4
n=6 Participants
|
S0597 Dose 5
n=6 Participants
|
Placebo
n=10 Participants
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
|
33 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
28 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
28 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
27 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
31 years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
27 years
STANDARD_DEVIATION 5.3 • n=8 Participants
|
29 years
STANDARD_DEVIATION 6.3 • n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Two (2) WeeksThe no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients
Outcome measures
| Measure |
S0597 Dose 1
n=6 Participants
The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo
|
S0597 Dose 2
n=6 Participants
|
S0597 Dose 3
n=6 Participants
|
S0597 Dose 4
n=6 Participants
|
S0597 Dose 5
n=6 Participants
|
Placebo
n=10 Participants
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
Adverse Events
S0597 Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S0597 Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S0597 Dose 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S0597 Dose 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
S0597 Dose 5
Serious events: 0 serious events
Other events: 1 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 |
S0597 Dose 1
n=6 participants at risk
Subjects will be administered with S0597
S0597: The subjects will receive S0597.
Placebo
|
S0597 Dose 2
n=6 participants at risk
The subjects will receive placebo.
S0597: The subjects will receive S0597.
Placebo
|
S0597 Dose 3
n=6 participants at risk
|
S0597 Dose 4
n=6 participants at risk
|
S0597 Dose 5
n=6 participants at risk
|
Placebo
n=10 participants at risk
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
URTI
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
headache
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/10
|
Additional Information
Dr Shravanti Bhowmik
SPARC
Phone: +91 22 66455645
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER