Trial Outcomes & Findings for Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide (NCT NCT01043146)
NCT ID: NCT01043146
Last Updated: 2013-04-08
Results Overview
To assess the safety and tolerability of COR-1.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
45 days
Results posted on
2013-04-08
Participant Flow
Participant milestones
| Measure |
Placebo
intravenous 0.9 % NaCl
|
10 mg COR-1
single intravenous administration
|
40 mg COR-1
single intravenous administration
|
80 mg COR-1
single intravenous administration
|
160 mg COR-1
single intravenous administration
|
240 mg COR-1
single intravenous administration
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Baseline characteristics by cohort
| Measure |
Placebo
n=10 Participants
intravenous 0.9 % NaCl
|
10 mg COR-1
n=8 Participants
single intravenous administration
|
40 mg COR-1
n=8 Participants
single intravenous administration
|
80 mg COR-1
n=8 Participants
single intravenous administration
|
160 mg COR-1
n=8 Participants
single intravenous administration
|
240 mg COR-1
n=8 Participants
single intravenous administration
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
50 Participants
n=8 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
|
|
Age Continuous
|
34.1 years
STANDARD_DEVIATION 8.61 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 7.09 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
31.9 years
STANDARD_DEVIATION 7.77 • n=4 Participants
|
30.1 years
STANDARD_DEVIATION 8.66 • n=21 Participants
|
27.5 years
STANDARD_DEVIATION 8.35 • n=8 Participants
|
31.6 years
STANDARD_DEVIATION 8.15 • 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
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
50 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 45 daysTo assess the safety and tolerability of COR-1.
Outcome measures
| Measure |
Placebo
n=10 Participants
intravenous 0.9 % NaCl
|
10 mg COR-1
n=8 Participants
single intravenous administration
|
40 mg COR-1
n=8 Participants
single intravenous administration
|
80 mg COR-1
n=8 Participants
single intravenous administration
|
160 mg COR-1
n=8 Participants
single intravenous administration
|
240 mg COR-1
n=8 Participants
single intravenous administration
|
|---|---|---|---|---|---|---|
|
The Number of Participants Reporting Adverse Events (AEs)
AE
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants Reporting Adverse Events (AEs)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
10 mg COR-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
40 mg COR-1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
80 mg COR-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
160 mg COR-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
240 mg COR-1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=10 participants at risk
intravenous 0.9 % NaCl
|
10 mg COR-1
n=8 participants at risk
single intravenous administration
|
40 mg COR-1
n=8 participants at risk
single intravenous administration
|
80 mg COR-1
n=8 participants at risk
single intravenous administration
|
160 mg COR-1
n=8 participants at risk
single intravenous administration
|
240 mg COR-1
n=8 participants at risk
single intravenous administration
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
not drug-related traumatic injury (achilles tendon) during sledging 8600 half-lives post drug admin.
|
0.00%
0/10
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=10 participants at risk
intravenous 0.9 % NaCl
|
10 mg COR-1
n=8 participants at risk
single intravenous administration
|
40 mg COR-1
n=8 participants at risk
single intravenous administration
|
80 mg COR-1
n=8 participants at risk
single intravenous administration
|
160 mg COR-1
n=8 participants at risk
single intravenous administration
|
240 mg COR-1
n=8 participants at risk
single intravenous administration
|
|---|---|---|---|---|---|---|
|
General disorders
feeling of cold at infusion site when drug was added to cold saline solution
|
0.00%
0/10
|
0.00%
0/8
|
37.5%
3/8 • Number of events 3
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can discuss and publish trial results upon review of results communication by the sponsor. The sponsor can require changes to the communication.
- Publication restrictions are in place
Restriction type: OTHER