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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: M6495

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03224702

2017-001663-21 (EudraCT Number)

MS200572-0009

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects with Body Mass Index (BMI) of greater than or equal to (>=) 18.5 and less than or equal to (=<) 29.9 Kilogram per square meter (kg/m^2), and a body weight between 50 and 100 kg at screening.
Subjects must agree to use effective method(s) of contraception during the trial.
Other protocol defined inclusion criteria could apply.

Exclusion criteria

Subjects who have recently participated in other clinical trials.
Donated blood, have a significant medical condition, history of drug hypersensitivity, consumption of large amounts of xanthine-containing foods or beverages, recent or ongoing concomitant medication, hypertension, tachycardia and significant findings on electrocardiogram
Positive drug screening test, positive test for Hepatitis B or C or human immune deficiency virus (HIV), or have been kept in detention
Other protocol defined exclusion criteria could apply.