Muscular Atrophy
Conditions
Interventions
96 mg GYM329 or placebo by subcutaneous injection
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Able and willing to provide written informed consent and to comply with the study protocol. Healthy men aged from 18 to less than 40 years at the time of consent. Right leg dominant. Agreement to limit physical activity as directed by study site staff from the time of informed consent until the end of the muscle strength evaluation period (completion of Day 43). Body mass index (BMI; weight in kg divided by height in meters squared) is between 18.5 and less than 25.0 at screening.
Exclusion criteria
Exclusion criteria: Current cardiovascular disorder, renal disorder, hepatic disorder, gastrointestinal disorder, hematologic disorder, immune disorder, neurologic disorder, endocrine disorder, metabolic disorder, or pulmonary disorder or a history of clinical significance for any of these disorders and impaired renal, hepatic, or cardiopulmonary function, as judged by the investigator. History of congenital myopathy. Congenital thrombophilia. Previous or current VTE. History of hip or limb surgery, spine or spinal cord surgery, or laparotomy (excluding laparotomy for appendicitis or inguinal hernia), or laparoscopic surgery (e.g. cholecystectomy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic Endpoints Percent change in thigh muscle strength score from Day 1 to Day 15 Percent change in thigh muscle strength score from Day 15 to Day 29 (Thigh muscle strength score: peak isometric knee extension torque and peak isokinetic knee extension torque at 90°/s and 180°/s) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Adverse events Laboratory tests Vital signs Electrocardiogram (ECG) Pharmacokinetic Endpoints: Serum GYM329 concentrations and PK parameters Immunogenicity Endpoint: Incidence of serum anti-GYM329 antibodies Pharmacodynamic Endpoints: Changes in thigh muscle volume over time Thigh muscle volume: MRI-derived thigh muscle cross-sectional area [CSA]) Serum PD biomarkers (total and free latent myostatin, mature myostatin) | — |
Countries
Netherlands
Outcome results
None listed