A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers; Heart Failure

Treatments: Drug: CDR132L (i.v.); Drug: CDR132L (s.c.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07656454

U1111-1319-6249 (Other Identifier)

NN6706-8230

2025-521329-34 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Sequence A

Experimental group

Description:

Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously.

Treatment:

Drug: CDR132L (s.c.)

Drug: CDR132L (i.v.)

Sequence B

Experimental group

Description:

Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously.

Treatment:

Drug: CDR132L (s.c.)

Drug: CDR132L (i.v.)

Sequence C

Experimental group

Description:

Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously.

Treatment:

Drug: CDR132L (s.c.)

Drug: CDR132L (i.v.)

Sequence D

Experimental group

Description:

Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously.

Treatment:

Drug: CDR132L (s.c.)

Drug: CDR132L (i.v.)