Multiple Ascending Doses (MAD) of Anti-A Disintegrin and Metalloproteinase With Thrombospondin Motifs-5 (Anti-ADAMTS-5) Nanobody in Participants With Knee Osteoarthritis (OA)
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|ClinicalTrials.gov Identifier: NCT03583346|
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Drug: M6495 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||August 23, 2018|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||July 31, 2019|
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.
|Placebo Comparator: Placebo||
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.
- Occurrences of Treatment-emergent Adverse Events (TEAEs), Treatment-related AEs and Serious AEs (SAEs) [ Time Frame: Day 1 up to Day 106 ]
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings [ Time Frame: Day 1 up to Day 106 ]Number of participants with clinically significant change from baseline will be reported.
- Occurrences of Injection Site Reactions [ Time Frame: Day 1 up to Day 43 ]
- Maximum Observed Serum Concentration (Cmax) of M6495 [ Time Frame: Day 1 up to Day 106 ]
- Dose Normalized Maximum Serum Concentration (Cmax/Dose) of M6495 [ Time Frame: Day 1 up to Day 106 ]
- Accumulation Ratio for Cmax (Racc [Cmax]) of M6495 [ Time Frame: Day 1, 15 and 29 ]
Following Racc parameters will be measured:
- Racc15 (Cmax): Cmax at Day 15/Cmax at Day 1
- Racc29 (Cmax): Cmax at Day 29/Cmax at Day 1
- Immunogenicity of M6495 as Assessed by Antidrug Antibodies (ADA) Assays [ Time Frame: Day 1 up to Day 106 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583346
|Copenhagen NV, Denmark, 2400|
|Study Director:||Medical Responsible||Merck KGaA, Darmstadt, Germany|