A Phase 1, Open-label, Single-centre Study Investigating the Effect of C21 on Forearm Blood Flow in Healthy Male Subjects by Use of Strain-gauge Venous Occlusion Plethysmography

VP-C21-009

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

2022-04-28

2022-05-11

2022-05-20

Completed

Early phase I

5

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will receive increasing doses of C21', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2022-11-14