NCT03224702

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2018

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

July 19, 2017

Last Update Submit

April 30, 2019

Conditions

Healthy

Keywords

M6495anti-A disintegrin and metalloproteinase with thrombospondin motifs-5 nanobodyOsteoarthritis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (15)

  • 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

  • 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

  • +10 more secondary outcomes

Study Arms (2)

M6495

EXPERIMENTAL
Drug: M6495

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

M6495DRUG

Subjects will receive M6495 on Day 1

M6495
PlaceboDRUG

Subjects will receive placebo matched to M6495 on Day 1

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 the trial.

You may not qualify if:

  • Subjects who have recently participated in other clinical trials.
  • Donated blood, have a significant medical condition, history of drug hypersensitivity, consumption of large amounts of xanthine-containing foods or beverages, recent or ongoing concomitant medication, hypertension, tachycardia and significant findings on electrocardiogram
  • Positive drug screening test, positive test for Hepatitis B or C or human immune deficiency virus (HIV), or have been kept in detention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DanTrials ApS c/o Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Medical Responsible

    Merck KGaA, Darmstadt, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

September 4, 2017

Primary Completion

August 6, 2018

Study Completion

August 6, 2018

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

DK(1)