Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708847
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2020-12-24
Brief Title:
A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer
Sponsor:
Chugai Pharmaceutical
Organization:
Chugai Pharmaceutical
Study Overview
Official Title:
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
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 12 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 11 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
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 12 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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None