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M6495

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

M6495 · 1 trial · 1 indication

Phase 1 1
NCT03224702First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy VolunteersHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about M6495

What is M6495 used for?

M6495 is an investigational small molecule being studied in healthy volunteers. It is a first-in-human anti-ADAMTS-5 nanobody being evaluated for safety and tolerability. The drug is not approved for any disease and is in Phase 1 clinical development.

What does M6495 target?

M6495 targets ADAMTS-5, an enzyme involved in cartilage breakdown. As an anti-ADAMTS-5 nanobody, it is designed to inhibit this target. The drug is being studied in a Phase 1 trial in healthy male volunteers to assess its safety profile.

Who makes M6495?

M6495 is being developed by Merck & Company, Inc., traded on the New York Stock Exchange under the ticker MRK. The company is conducting a Phase 1 clinical trial of this investigational small molecule in healthy volunteers.

What phase is M6495 in?

M6495 is in Phase 1 clinical development. It is an investigational drug, not approved by regulatory authorities. A first-in-human trial of M6495 in healthy volunteers has been completed, with results not yet reported.

What clinical trials is M6495 in?

M6495 has one completed Phase 1 clinical trial, NCT03224702, titled "First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers." This randomized, double-blind, placebo-controlled study enrolled 54 healthy male participants in Denmark.

Is M6495 the same as anti-ADAMTS-5 nanobody?

M6495 is an anti-ADAMTS-5 nanobody, as described in the clinical trial title. The drug is a small molecule that targets ADAMTS-5. No other alternative names for M6495 have been disclosed.