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drugset / Trial / NCT05624580

A Study to Look at Safety and Tolerability of NNC0582-0001, How it is Transported Throughout the Body and How it Works in Healthy Adults

NCT05624580 ↗

Phase 1 Completed 56 enrolled Novo Nordisk A/S
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a single-center, randomized, double-blind, sequential-group, placebo-controlled study with six sequential single dose cohorts with ascending dose levels in healthy adult participants. This study will assess the safety, tolerability, the pharmacokinetics from single subcutaneous administrations of NNC0582-0001 and explores the pharmacodynamics in healthy participants. Participants will be randomized in a 3:1 ratio to receive a fixed single dose (1-day) of NNC0582 0001 or placebo by injections under the skin. Participants will be followed up for 52 weeks post dose.

Timeline

Start
2022-11-15
Primary completion
2025-10-16
Completion
2025-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject NNC0582-0001 Unknown 10 mg Subcutaneous
Subject NNC0582-0001 Unknown 30 mg Subcutaneous
Subject NNC0582-0001 Unknown 90 mg Subcutaneous
Subject NNC0582-0001 Unknown 250 mg Subcutaneous
Subject NNC0582-0001 Unknown 600 mg Subcutaneous
Subject NNC0582-0001 Unknown 1000 mg Subcutaneous

Indications

No indication recorded.