Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

25. juni 2026 opdateret af: Novo Nordisk A/S

A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants

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.

Studieoversigt

Status

Rekruttering

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Berlin, Tyskland, 14050
        • Rekruttering
        • Parexel International GmbH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence A
Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously.
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
Eksperimentel: Sequence B
Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously.
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
Eksperimentel: Sequence C
Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously.
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
Eksperimentel: Sequence D
Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously.
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured as hours*nanograms per milliliter (h*ng/mL)
From 0 to 840 hours after CDR132L administration

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured as h*ng/mL
From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured as nanograms per milliliter (ng/mL)
From 0 to 840 hours after CDR132L administration
Maximum observed CDR132L plasma concentration after a single dose divided by dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured as nanograms per milliliter per milligram (ng/mL/mg)
From 0 to 840 hours after CDR132L administration
Time to maximum observed CDR132L plasma concentration after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured in hours
From 0 to 840 hours after CDR132L administration
Terminal half-life for CDR132L after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured in hours
From 0 to 840 hours after CDR132L administration
Area under the CDR132L plasma concentration-time curve from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration, divided by dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured as hours*nanograms per milliliter per milligram (h*ng/mL/mg)
From 0 to 840 hours after CDR132L administration
Total plasma clearance of CDR132L after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured as liters per hour
From 0 to 840 hours after CDR132L administration
Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured in liters
From 0 to 840 hours after CDR132L administration
Mean residence time for CDR132L after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
Measured in hours
From 0 to 840 hours after CDR132L administration
Number of adverse events
Tidsramme: From first CDR132L administration (day 1) to day 141
Measured as number of events
From first CDR132L administration (day 1) to day 141

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juni 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

14. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN6706-8230
  • U1111-1319-6249 (Anden identifikator: World Health Organization (WHO))
  • 2025-521329-34 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjertefejl

Kliniske forsøg med CDR132L (s.c.)

3
Abonner