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First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers

NCT03224702 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-05-02

No results posted yet for this study

Summary

This First-In-Human trial will be conducted in healthy male subjects to explore the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of M6495.

Conditions

  • Healthy

Interventions

DRUG

M6495

Subjects will receive M6495 on Day 1

DRUG

Placebo

Subjects will receive placebo matched to M6495 on Day 1

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-04
Primary Completion
2018-08-06
Completion
2018-08-06

Countries

  • Denmark

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 NCT03224702 on ClinicalTrials.gov