Study Vasodilatory Effects of C21Phase 1NCT05277922
Effect of C21 on Forearm Blood Flow
A Phase 1 study testing C21 and Sodium Nitroprusside in people with Study Vasodilatory Effects of C21, run by Vicore Pharma AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Study Vasodilatory Effects of C21
- What is being tested?
- C21 and Sodium Nitroprusside
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- 28 Apr 2022to 18 May 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.
Read the 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
- Being tested
- C21, Sodium Nitroprusside
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C21Drug
Also called Compund 21
C21 in ascending doses of 15, 50, 150, 500 and 1000 µg
Sodium NitroprussideDrug
Also called Nipruss
Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Sodium Nitroprusside |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 85 minutes
Secondary outcomes (8)
Dose-response Curve of C21 on Forearm Blood Flow (FBF)
Geometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min)
Measured: 85 min
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside
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)
Measured: 45 minutes
Frequency of Adverse Events
Total number of adverse events was counted
Measured: Day 1-7
Number of Mild, Moderate, and Severe Adverse Events
Number of mild, moderate, and severe adverse events was counted
Measured: Day 1-7
Number of Serious Adverse Events (SAEs)
Number of serious adverse events (SAEs) was counted
Measured: Day 1-7
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
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
Measured: 5 hours
Number of Participants With Clinically Significant Changes in ECG Parameters
Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean values of the ECG parameters were counted
Measured: 5 hours
Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
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
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start28 Apr 2022
- Primary completion11 May 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Study Vasodilatory Effects of C21Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Subjects will receive increasing doses of C21
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vicore Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277922
- Sponsor's protocol ID
- VP-C21-009
- Status last verified
- Apr 2025
- First submitted
- 3 Mar 2022
- Last updated
- 23 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38344891
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05277922
- Acronym / sponsor ID
- VP-C21-009
- Conditions
- Study Vasodilatory Effects of C21
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vicore Pharma ABIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Posted 23 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will receive increasing doses of C21
| Arm | Type | Receives |
|---|---|---|
| C21 combined | Experimental | Drug: C2115 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 | Experimental | Drug: Sodium Nitroprusside4 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C21Also: Compund 21C21 in ascending doses of 15, 50, 150, 500 and 1000 µg | Drug | C21 combined |
| Sodium NitroprussideAlso: NiprussAscending doses of 4, 8 and 16 µg sodium nitroprusside Positive control | Drug | Positive control |
Primary outcome
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21
Time frame: 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)
8 secondary outcomes
Dose-response Curve of C21 on Forearm Blood Flow (FBF)
Time frame: 85 min
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside
Time frame: 45 minutes
Frequency of Adverse Events
Time frame: Day 1-7
Number of Mild, Moderate, and Severe Adverse Events
Time frame: Day 1-7
Number of Serious Adverse Events (SAEs)
Time frame: Day 1-7
Number of Participants With Clinically Significant Changes in Vital Sign Parameters
Time frame: 5 hours
Number of Participants With Clinically Significant Changes in ECG Parameters
Time frame: 5 hours
Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
Time frame: 5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38344891Rein-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C21 and Sodium Nitroprusside in people with Study Vasodilatory Effects of C21, run by Vicore Pharma AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21 (time frame: 85 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.