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Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals

NCT06117020 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-03-12

No results posted yet for this study

Summary

To assess the safety and tolerability of single and multiple doses of MTR-601 in normal healthy volunteers under fed and fasted conditions.

To evaluate the plasma and urine pharmacokinetics (PK) of MTR-601. To evaluate the pharmacodynamic (PD) effects of MTR-601 on muscle strength and muscle accumulation of MTR-601 by muscle biopsy and other potential mechanistic, predictive and PD markers of MTR-601.

Conditions

  • Muscle Spasticity
  • Hypertonia, Muscle
  • Cerebral Palsy
  • Multiple Sclerosis
  • Stroke
  • Hereditary Spastic Paraplegia
  • Dystonia
  • Spinal Cord Injuries

Interventions

DRUG

MTR-601

Safety and tolerability of oral MTR-601, a highly selective fast twitch myosin 2 ATPase inhibitor in normal healthy volunteers

Sponsors & Collaborators

  • Motric Bio

    lead INDUSTRY

Principal Investigators

  • Alan Hand, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2024-10-16
Completion
2024-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06117020 on ClinicalTrials.gov