Effect of C21 on Forearm Blood Flow

NCT ID: NCT05277922

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2022-05-18

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.

Conditions

Study Vasodilatory Effects of C21

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

C21

Intervention Type: DRUG

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)

Group Type: EXPERIMENTAL

Sodium Nitroprusside

Intervention Type: DRUG

Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control

Interventions

C21

C21 in ascending doses of 15, 50, 150, 500 and 1000 µg

Intervention Type: DRUG

Sodium Nitroprusside

Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control

Intervention Type: DRUG

Other Intervention Names

Compund 21; Nipruss

Eligibility Criteria

Inclusion Criteria

1. Willing and able to give written informed consent for participation in the study and to comply with study requirements.

2. Healthy male subject aged 18-45 years

3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.

4. Wlling to use condom or be vasectomised or practice sexual abstinence

5. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values

Exclusion Criteria

1. 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.

2. History of thrombotic disease, vascular disorder, or severe bleeding disease.

3. Poor brachial artery access.

4. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of baseline

5. 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.

6. Any planned major surgery within the duration of the study.

7. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).

8. Abnormal vital signs

9. Prolonged QT interval, cardiac arrhythmias or any clinically significant abnormalities in the resting ECG

10. 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.

11. Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals

12. Regular use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid

13. Vaccination within 1 week prior to dosing or plans to receive any vaccine during the study conduct.

14. Planned treatment or treatment with another investigational drug within 3 months

15. Current regular smokers or users of nicotine products.

16. History of alcohol abuse

17. Presence or history of drug abuse

18. Positive screen for drugs of abuse or alcohol at screening

19. History of, or current use of, anabolic steroids.

20. Inability to refrain from consuming caffeine-containing beverages during Day 1

21. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.

22. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

CTC Clinical Trial Consultants AB

INDUSTRY

Sponsor Role: collaborator

Vicore Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Consultants AB

Uppsala, Uppsala Lân, Sweden

Countries

Sweden

References

Rein-Hedin E, Sjoberg F, Ganslandt C, Skoog J, Zachrisson H, Bengtsson T, Dalsgaard CJ. Utilizing venous occlusion plethysmography to assess vascular effects: A study with buloxibutid, an angiotensin II type 2 receptor agonist. Clin Transl Sci. 2024 Feb;17(2):e13735. doi: 10.1111/cts.13735.

Reference Type: DERIVED

PMID: 38344891 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VP-C21-009

Identifier Type: -

Identifier Source: org_study_id