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M6495

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: May 2, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03224702First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy VolunteersPHASE1 COMPLETED 54 — — Sep 4, 2017Aug 6, 2018May 2, 20191 Denmark
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Study Endpoints
Primary Endpoints
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
Secondary Endpoints
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
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
M6495EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
M6495DRUGSubjects will receive M6495 on Day 1
PlaceboDRUGSubjects will receive placebo matched to M6495 on Day 1
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects with Body Mass Index (BMI) of greater than or equal to (\>=) 18.5 and less than or equal to (=\<) 29.9 Kilogram per square meter (kg/m\^2), and a body weight between 50 and 100 kg at screening. * Subjects must agree to use effective method(s) of contraception during t...

Countries:Denmark
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