NCT07656454RecruitingPhase 1
A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants
A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 14 Jun 2026
- Start date
- 17 Jun 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Heart failure
- NCT number
- NCT07656454
- EU CT number
- 2025-521329-34-00
- EudraCT number
- 2025-521329-34
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 17 Jun 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.
- 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).
Lab values
- 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).
- 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 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parexel International GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.