Trial Outcomes & Findings for Effect of C21 on Forearm Blood Flow (NCT NCT05277922)
NCT ID: NCT05277922
Last Updated: 2025-04-23
Results Overview
Percentage change from baseline in forearm blood flow (FBF) in response to increasing intraarterial doses of C21 (3, 10, 30, 100, and 200 μg/min)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
85 minutes
Results posted on
2025-04-23
Participant Flow
5 subjects were enrolled into the trial and all subjects received 5 ascending doses of C21 followed by 3 ascending doses of sodium nitroprusside as a positive control. Thus, the 5 subjects were reused for both C21 and sodium nitroprusside treatment.
Participant milestones
| Measure |
C21 Combined
15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min)
C21: C21 in ascending doses of 15, 50, 150, 500 and 1000 µg
|
Positive Control
4 µg nitroprusside (infusion rate 0.8 µg/min) 8 µg nitroprusside (infusion rate 1.6 µg/min) 16 µg nitroprusside (infusion rate 3.2 µg/min)
Sodium Nitroprusside: Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control
|
|---|---|---|
|
15 µg C21
STARTED
|
5
|
0
|
|
15 µg C21
COMPLETED
|
5
|
0
|
|
15 µg C21
NOT COMPLETED
|
0
|
0
|
|
50 µg C21
STARTED
|
5
|
0
|
|
50 µg C21
COMPLETED
|
5
|
0
|
|
50 µg C21
NOT COMPLETED
|
0
|
0
|
|
150 µg C21
STARTED
|
5
|
0
|
|
150 µg C21
COMPLETED
|
5
|
0
|
|
150 µg C21
NOT COMPLETED
|
0
|
0
|
|
500 µg C21
STARTED
|
5
|
0
|
|
500 µg C21
COMPLETED
|
5
|
0
|
|
500 µg C21
NOT COMPLETED
|
0
|
0
|
|
1000 µg C21
STARTED
|
5
|
0
|
|
1000 µg C21
COMPLETED
|
5
|
0
|
|
1000 µg C21
NOT COMPLETED
|
0
|
0
|
|
4 µg Nitroprusside
STARTED
|
0
|
5
|
|
4 µg Nitroprusside
COMPLETED
|
0
|
5
|
|
4 µg Nitroprusside
NOT COMPLETED
|
0
|
0
|
|
8 µg Nitroprusside
STARTED
|
0
|
5
|
|
8 µg Nitroprusside
COMPLETED
|
0
|
5
|
|
8 µg Nitroprusside
NOT COMPLETED
|
0
|
0
|
|
16 µg Nitroprusside
STARTED
|
0
|
5
|
|
16 µg Nitroprusside
COMPLETED
|
0
|
5
|
|
16 µg Nitroprusside
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of C21 on Forearm Blood Flow
Baseline characteristics by cohort
| Measure |
C21 Combined
n=5 Participants
15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min)
C21: C21 in ascending doses of 15, 50, 150, 500 and 1000 µg
|
|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
180.0 cm
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Weight
|
86.8 kg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Body mass index
|
26.8 kg/m2
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 85 minutesPercentage change from baseline in forearm blood flow (FBF) in response to increasing intraarterial doses of C21 (3, 10, 30, 100, and 200 μg/min)
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
n=5 Participants
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
n=5 Participants
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
n=5 Participants
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21
|
27.8 percentage of change from baseline
Standard Deviation 24.3
|
17.2 percentage of change from baseline
Standard Deviation 5.5
|
37.0 percentage of change from baseline
Standard Deviation 26.6
|
28.5 percentage of change from baseline
Standard Deviation 22.7
|
60.5 percentage of change from baseline
Standard Deviation 38.3
|
SECONDARY outcome
Timeframe: 85 minGeometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min)
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
n=5 Participants
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
n=5 Participants
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
n=5 Participants
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Dose-response Curve of C21 on Forearm Blood Flow (FBF)
|
2.594 mL/min
Geometric Coefficient of Variation 43.2
|
2.594 mL/min
Geometric Coefficient of Variation 32.4
|
3.231 mL/min
Geometric Coefficient of Variation 44.7
|
3.215 mL/min
Geometric Coefficient of Variation 38.1
|
3.907 mL/min
Geometric Coefficient of Variation 24.5
|
SECONDARY outcome
Timeframe: 45 minutesPercentage change from baseline in forearm blood flow in response to increasing intra-arterial doses of sodium nitroprusside (0.8, 1.6, and 3.2 μg/min)
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
n=5 Participants
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside
|
319.8 percentage of change from baseline
Standard Deviation 186.0
|
229.5 percentage of change from baseline
Standard Deviation 73.1
|
319.6 percentage of change from baseline
Standard Deviation 141.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-7Total number of adverse events was counted
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Frequency of Adverse Events
|
3 Number of adverse events
|
3 Number of adverse events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-7Number of mild, moderate, and severe adverse events was counted
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Number of Mild, Moderate, and Severe Adverse Events
Number of mild AEs
|
3 Number of events
|
3 Number of events
|
—
|
—
|
—
|
|
Number of Mild, Moderate, and Severe Adverse Events
Number of moderate Aes
|
0 Number of events
|
0 Number of events
|
—
|
—
|
—
|
|
Number of Mild, Moderate, and Severe Adverse Events
Number of severe AEs
|
0 Number of events
|
0 Number of events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1-7Number of serious adverse events (SAEs) was counted
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Number of Serious Adverse Events (SAEs)
|
0 Number of SAEs
|
0 Number of SAEs
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 hoursParticipants with Clinically significant changes from baseline (screening ) to the end of treatment in mean systolic blood pressure, diastolic blood pressure or pulse rate were counted
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 hoursParticipants with Clinically significant changes from baseline (screening ) to the end of treatment in mean values of the ECG parameters were counted
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in ECG Parameters
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 hoursParticipants with Clinically significant changes from baseline (screening ) to the end of treatment (Day 1) in mean clinical chemistry, haematology or coagulation parameters were counted
Outcome measures
| Measure |
C21 3 ug/Min
n=5 Participants
First dose of C21: 3 ug/min
|
C21 10 ug/Min
n=5 Participants
Second dose of C21: 10 ug/min
|
C21 30 ug/Min
Third dose of C21: 30 ug/min
|
C21 100 ug/Min
Fourth dose of C21: 100 ug/min
|
C21 200 ug/Min
Last dose of C21: 200 ug/min
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
C21 Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total
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 |
C21 Group
n=5 participants at risk
Participants infused with increasing doses of C21
|
Total
n=5 participants at risk
All participants (infused with C21 and nitroprusside)
|
|---|---|---|
|
General disorders
Infusion site bruising
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
|
|
Nervous system disorders
Presyncope
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place