Safety, Tolerability, and Pharmacodynamics of the ADAMTS-5 Nanobody M6495: Two Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Studies in Healthy Subjects and Patients With Osteoarthritis.

ABSTRACT:

Objective

To assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple injections of M6495, a disintegrin and metalloproteinase with thrombospondin motifs 5 (ADAMTS-5)  nanobody, in healthy volunteers and patients with osteoarthritis.

Methods

Two randomized, placebo-controlled, double-blind studies were performed. Study 1 enrolled 54 healthy male volunteers who received one subcutaneous (s.c.) injection of M6495 (1-300 mg) or placebo (ratio 2:1), evaluating safety, PK, and PD as changes in the serum aggrecan fragment alanine-arginine-glycine-serine (ARGS). Study 2 enrolled 32 patients with osteoarthritis with Kellgren-Lawrence grades 2 to 4 and pain greater than or equal to 40 on the Western Ontario and McMaster Universities Arthritis Index p

SUBMITTER: Bihlet AR 

PROVIDER: S-EPMC11016567 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature