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.
- Conditions
- Muscular Atrophy10028302
- Registration Number
- NL-OMON54969
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacodynamic Endpoints<br /><br>Percent change in thigh muscle strength score from Day 1 to Day 15<br /><br>Percent change in thigh muscle strength score from Day 15 to Day 29<br /><br>(Thigh muscle strength score: peak isometric knee extension torque and peak<br /><br>isokinetic knee extension torque at 90°/s and 180°/s)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety Endpoints:<br /><br>Adverse events<br /><br>Laboratory tests<br /><br>Vital signs<br /><br>Electrocardiogram (ECG)<br /><br><br /><br>Pharmacokinetic Endpoints:<br /><br>Serum GYM329 concentrations and PK parameters<br /><br><br /><br>Immunogenicity Endpoint:<br /><br>Incidence of serum anti-GYM329 antibodies<br /><br><br /><br>Pharmacodynamic Endpoints:<br /><br>Changes in thigh muscle volume over time<br /><br>Thigh muscle volume: MRI-derived thigh muscle cross-sectional area [CSA])<br /><br>Serum PD biomarkers (total and free latent myostatin, mature myostatin)</p><br>