How CDR132L enters the bloodstream after under-the-skin vs. vein injections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study compares two routes of administration for CDR132L (intravenous and subcutaneous) to determine systemic exposure in healthy volunteers. The trial assesses pharmacokinetics and safety to inform future use in heart failure patients. Adults aged 18 to 55 who are generally healthy will receive either IV or subcutaneous injections and undergo serial blood sampling and safety monitoring. The study aims to identify the more favorable delivery method for achieving therapeutic exposure while monitoring for adverse effects. No efficacy outcomes in patients with heart failure are being tested at this stage.

Why it matters

Who can join: the full rules

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).

Where it's running

• Parexel International GmbH
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.