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

NCT06577337 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-12
Primary Completion
2026-11-18
Completion
2027-03-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577337 on ClinicalTrials.gov