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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001663-21 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M6495 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M6495 | Drug | Subjects will receive M6495 on Day 1 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Baseline up to Day 75 | |
| Occurrence of TEAEs and SAEs by Severity | Baseline up to Day 75 | |
| Number of Subjects With Injection Site Reactions (ISRs) | Baseline up to Day 75 | |
| Number of Subjects with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings | Baseline up to Day 75 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose | |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DanTrials ApS c/o Bispebjerg Hospital | Copenhagen | DK-2400 | Denmark |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Drug |
Subjects will receive placebo matched to M6495 on Day 1 |
|
| Area Under the Concentration-Time Curve From Time Zero to the Last Sampling Time (t) at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Apparent Terminal Half-Life (t1/2) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Apparent Terminal Rate Constant (λz) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Apparent Body Clearance (CL/F) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Percent Change From Baseline in Serum Aggrecan Degradation neo-Epitope (ARGS) at Day 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 22, 29, 39, 49, 61 and 75 | Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 22, 29, 39, 49, 61 and 75 |
| Number of Subjects With Anti-drug Antibodies (ADA) for M6495 | Pre-dose, Day 8, 22, 49 and 75 |
| Levels of Anti-Drug Antibodies (ADA) Titers | Pre-dose, Day 8, 22, 49 and 75 |
| Change From Baseline in Telemetry Electrocardiogram (ECG) Intervals Up to 24 hours post Day 1 dose | Baseline, Up to 24 hours post Day 1 dose |
| Slope of Exposure vs QTc From Digital Electrocardiogram Triplicates | Baseline up to Day 75 |
| Maximal Effect (Imax) of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |
| Inhibitory Concentration (IC) 10, IC50 and IC90 of M6495 | Pre-dose and 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 912, 1152, 1440, 1776 hours post-dose |