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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
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.
DanTrials ApS
Copenhagen NV, Denmark
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
Number of participants with clinically significant change from baseline will be reported.
Time frame: Day 1 up to Day 106
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
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
Time frame: Day 1, 15 and 29
Immunogenicity of M6495 as Assessed by Antidrug Antibodies (ADA) Assays
Time frame: Day 1 up to Day 106
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