NCT07656454 A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants
| NCT ID | NCT07656454 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novo Nordisk A/S |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-06-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.
Eligibility Criteria
Inclusion Criteria: * Male or female (sex at birth). * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index 18.5-29.9 kilograms per square metre (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1). * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator. Exclusion Criteria: * Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values. * Alanine aminotransferase (ALT) greater than (\>) upper limit of normal (ULN) +10 percentage (%) * Aspartate aminotransferase (AST) \>ULN +20% * Bilirubin \>ULN +20% * Creatinine \>ULN +10% * Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) less than (\<) 90 milliliters per minute/1.73square meter (mL/min/1.73m\^2) * Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg/g) * Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1). * Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic. * Heart rate outside the range of 50-89 beats/minute at screening (visit 1). * Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders. * Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin \<90 grams per litre (g/L)) * Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury. * Presence of thrombocytopenia, defined as thrombocyte count \<150 x 10\^9 cells/L at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder. * Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).
Contact & Investigator
Clinical Transparency (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07656454 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07656454 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07656454 currently recruiting?
Yes, NCT07656454 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07656454 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07656454 clinical trial?
NCT07656454 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 32 participants.