A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer
Status:
Recruiting
Trial end date:
2022-10-31
Target enrollment:
Participant gender:
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).