Effect of C21 on Forearm Blood Flow

Phase 1

Completed

Conditions: Study Vasodilatory Effects of C21

Interventions: Drug: C21
Drug: Sodium Nitroprusside

Registration Number: NCT05277922

Lead Sponsor: Vicore Pharma AB

Brief Summary: The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.

Detailed Description: Subject will be screened for eligibility. Eligible subjects will receive ascending doses of C21 (3, 10, 30, 100, and 200 µg/min through local intra-arterial infusions for 5 min/dose. Forearm blood flow measurements will be performed in both arms during the last 2 minutes of each dose.

Infusions of sodium nitroprusside will be performed as a positive control using the same methodology.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 5

Inclusion Criteria

Willing and able to give written informed consent for participation in the study and to comply with study requirements.
Healthy male subject aged 18-45 years
Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
Wlling to use condom or be vasectomised or practice sexual abstinence
Clinically normal medical history, physical findings, vital signs, ECG and laboratory values

Exclusion Criteria

History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History of thrombotic disease, vascular disorder, or severe bleeding disease.
Poor brachial artery access.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of baseline
Malignancy within the past 5 years with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Any planned major surgery within the duration of the study.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
Abnormal vital signs
Prolonged QT interval, cardiac arrhythmias or any clinically significant abnormalities in the resting ECG
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to the IMPs, including any of the excipients of the IMPs.
Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals
Regular use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid
Vaccination within 1 week prior to dosing or plans to receive any vaccine during the study conduct.
Planned treatment or treatment with another investigational drug within 3 months
Current regular smokers or users of nicotine products.
History of alcohol abuse
Presence or history of drug abuse
Positive screen for drugs of abuse or alcohol at screening
History of, or current use of, anabolic steroids.
Inability to refrain from consuming caffeine-containing beverages during Day 1
Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C21 combined	C21	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)
Positive control	Sodium Nitroprusside	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)

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21	85 minutes	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)

Secondary Outcome Measures

Name	Time	Method
Dose-response Curve of C21 on Forearm Blood Flow (FBF)	85 min	Geometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min)
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside	45 minutes	Percentage 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)
Frequency of Adverse Events	Day 1-7	Total number of adverse events was counted
Number of Mild, Moderate, and Severe Adverse Events	Day 1-7	Number of mild, moderate, and severe adverse events was counted
Number of Serious Adverse Events (SAEs)	Day 1-7	Number of serious adverse events (SAEs) was counted
Number of Participants With Clinically Significant Changes in Vital Sign Parameters	5 hours	Participants 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
Number of Participants With Clinically Significant Changes in ECG Parameters	5 hours	Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean values of the ECG parameters were counted
Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters	5 hours	Participants with Clinically significant changes from baseline (screening ) to the end of treatment (Day 1) in mean clinical chemistry, haematology or coagulation parameters were counted