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RECRUITING
NCT06577337
PHASE1

Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The present study in healthy participants will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics(PD) of single ascending doses (SAD) of subcutaneously administered M5542.

Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of M5542 Administered Subcutaneously in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2024-09-12

Completion Date

2027-03-09

Last Updated

2026-04-01

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

M5542

Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.

BIOLOGICAL

Placebo

Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.

Locations (1)

Clinical Pharmacology Unit of Nuvisan GmbH

Neu-Ulm, Germany