Skip to main content
OpenTrials
Completed

NCT Number: NCT03224702

First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

DanTrials ApS c/o Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 the trial.
  • Other protocol defined inclusion criteria could apply.

Exclusion criteria

  • 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
  • Other protocol defined exclusion criteria could apply.

Treatment and study plan

M6495

Drug

Subjects will receive M6495 on Day 1

Placebo

Drug

Subjects will receive placebo matched to M6495 on Day 1

Primary outcomes

  1. Occurrence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

    Time frame: Baseline up to Day 75

  2. Occurrence of TEAEs and SAEs by Severity

    Time frame: Baseline up to Day 75

  3. Number of Subjects With Injection Site Reactions (ISRs)

    Time frame: Baseline up to Day 75

  4. Number of Subjects with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings

    Time frame: Baseline up to Day 75

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of M6495

    Time frame: 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

  2. Time to Reach Maximum Observed Serum Concentration (Tmax) of M6495

    Time frame: 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

  3. 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

    Time frame: 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

  4. Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M6495

    Time frame: 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

  5. Apparent Terminal Half-Life (t1/2) of M6495

    Time frame: 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

  6. Apparent Terminal Rate Constant (λz) of M6495

    Time frame: 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

  7. Apparent Body Clearance (CL/F) of M6495

    Time frame: 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

  8. Apparent Volume of Distribution During the Terminal Phase (Vz/F) of M6495

    Time frame: 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

  9. 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

    Time frame: Baseline, Day 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 22, 29, 39, 49, 61 and 75

  10. Number of Subjects With Anti-drug Antibodies (ADA) for M6495

    Time frame: Pre-dose, Day 8, 22, 49 and 75

  11. Levels of Anti-Drug Antibodies (ADA) Titers

    Time frame: Pre-dose, Day 8, 22, 49 and 75

  12. Change From Baseline in Telemetry Electrocardiogram (ECG) Intervals Up to 24 hours post Day 1 dose

    Time frame: Baseline, Up to 24 hours post Day 1 dose

  13. Slope of Exposure vs QTc From Digital Electrocardiogram Triplicates

    Time frame: Baseline up to Day 75

  14. Maximal Effect (Imax) of M6495

    Time frame: 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

  15. Inhibitory Concentration (IC) 10, IC50 and IC90 of M6495

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Single-Center, Phase I, Randomized, Double Blind, Placebo-Controlled, First-In-Human Trial to Assess the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Subcutaneous Injected M6495 (Anti-ADAMTS-5 Nanobody) in Healthy Male Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.