DanTrials ApS
Copenhagen NV, 2400, Denmark
NCT Number: NCT03583346
The study will be conducted in participants with symptomatic knee OA to explore the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of MAD of M6495.
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Notify Me40 year–75 year
All sexes
Interventional
Phase 1
Copenhagen NV, 2400, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive escalated dose of M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4.
Participants will receive placebo matched to M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4.
Time frame: Day 1 up to Day 106
Time frame: Day 1 up to Day 106
Number of participants with clinically significant change from baseline will be reported.
Time frame: Day 1 up to Day 43
Time frame: Day 1 up to Day 106
Time frame: Day 1 up to Day 106
Time frame: Day 1, 15 and 29
Following Racc parameters will be measured:
Time frame: Day 1 up to Day 106
Merck KGaA, Darmstadt, Germany
Industry
A Phase Ib, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injections of M6495 (Anti-ADAMTS-5 Nanobody) in Participants With Symptomatic Knee Osteoarthritis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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