NCT04708847

A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer

A Double-Blind, Placebo-Controlled, Randomized Clinical Pharmacology Study to Evaluate the Prevention Effect and the Recovery-Promoting Effect of a Single Subcutaneous Administration of GYM329 on Disuse Muscle Atrophy in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: Male
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

This study will induce disuse atrophy through unilateral immobilization of the thigh and lower leg in healthy male volunteers to evaluate the PD of a single subcutaneous dose of GYM329 prior to or after unilateral thigh and lower leg immobilization. Healthy male volunteers will receive either GYM329 or placebo by subcutaneous injection at two time points, before and after 2 weeks of unilateral thigh and lower leg immobilization, in an investigator- and subject-blinded, randomized, placebo-controlled, parallel-group design. At enrollment, all subjects will be randomized in a 1:2 ratio to either the pre-immobilization active drug group receiving a single subcutaneous dose of GYM329 before unilateral thigh and lower leg immobilization (Group A) or the pre-immobilization placebo group receiving a single subcutaneous dose of placebo before unilateral thigh and lower leg immobilization (Group B). On Day 15, subjects assigned to Group B and who completed the muscle strength assessment at Day15 will be further randomized in a 1:1 ratio to either the post-immobilization active drug group (Group B-1) or the post-immobilization placebo group (Group B-2). Group A will receive GYM329 on Day 1 and placebo on Day 15. Group B will receive placebo on Day 1. Subsequently, Group B-1 will receive GYM329 on Day 15 and Group B-2 will receive placebo on Day 15. Muscle strength will be measured at pre-immobilization of unilateral thigh and lower leg, post-immobilization of unilateral thigh and lower leg (Day 15), Day 29, and Day 43. Subjects will be observed for 252 days after the second study treatment administration (266 days after the first study treatment administration).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GYM329	GYM329 subcutaneous injection
DRUG	Placebo	Placebo subcutaneous injection

Timeline

• Start date: 2021-02-10
• Primary completion: 2022-06-03
• Completion: 2023-02-01
• First posted: 2021-01-14
• Last updated: 2023-02-17

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study