NCT03224702

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

A Single-Center, Phase I, Randomized, Double Blind, Placebo-Controlled, First-In-Human Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous Injected M6495 (Anti-ADAMTS-5 Nanobody) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	M6495	Subjects will receive M6495 on Day 1
DRUG	Placebo	Subjects will receive placebo matched to M6495 on Day 1

Timeline

• Start date: 2017-09-04
• Primary completion: 2018-08-06
• Completion: 2018-08-06
• First posted: 2017-07-21
• Last updated: 2019-05-02

Locations

1 site across 1 country: Denmark