Effect of C21 on Forearm Blood Flow

NCT05277922 | Completed Phase 1 Results

• 1 other identifier: VP-C21-009
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Study Vasodilatory Effects of C21

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21

  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)

  85 minutes

Secondary Outcomes (8)

• Dose-response Curve of C21 on Forearm Blood Flow (FBF)

  85 min

• Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside

  45 minutes

• Frequency of Adverse Events

  Day 1-7

• Number of Mild, Moderate, and Severe Adverse Events

  Day 1-7

• Number of Serious Adverse Events (SAEs)

  Day 1-7

Study Arms (2)

C21 combined

EXPERIMENTAL

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)

Drug: C21

Positive control

EXPERIMENTAL

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)

Drug: Sodium Nitroprusside

Interventions

C21 DRUG

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

Also known as: Compund 21

C21 combined

Sodium Nitroprusside DRUG

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

Also known as: Nipruss

Positive control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vicore Pharma AB: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

Clinical Trial Consultants AB

Uppsala, Uppsala Lân, 75237, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38344891 DERIVED

MeSH Terms

Interventions

compound 21; Nitroprusside

Intervention Hierarchy (Ancestors)

Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds

Results Point of Contact

• Title: Cecilia Ganslandt
• Organization: Vicore Pharma AB

info@vicorepharma.com

+46 705 797075

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will receive increasing doses of C21

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 14, 2022
• Study Start: April 28, 2022
• Primary Completion: May 11, 2022
• Study Completion: May 18, 2022
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)