NCT04708847

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

Completed Phase 1 Last updated 17 February 2023

What this trial tests

Phase 1 trial testing GYM329 in Healthy Volunteers in 30 participants. Completed in 1 February 2023.

Timeline

10 February 2021

Primary endpoint
3 June 2022

1 February 2023

Quick facts

Lead sponsor	Chugai Pharmaceutical
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	10 February 2021
Primary completion	3 June 2022
Estimated completion	1 February 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• GYM329 — full drug profile →
• Placebo

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Chugai Pharmaceutical — full company profile →

Who can join

Adults 18 to 39, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.