Status:
COMPLETED
A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-39 years
Phase:
PHASE1
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 aft...
Eligibility Criteria
Inclusion
- 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
- Agreed 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)
- BMI is between 18.5 and less than 25.0 at screening
- Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
Exclusion
- 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)
- History of fracture of the pelvis or open/compound fracture of lower limb, or history of fracture within 3 years prior to screening, excluding digit fracture
- History of severe trauma, trauma requiring surgical intervention, or trauma with organ injury which deemed as clinically significant by the investigator
- Previous or current medical condition that could lead to thrombosis as judged by the investigator
- Angiography within 6 months before first study treatment administration
- Current Grade ≥ 3 thermal burn or history of Grade ≥ 3 thermal burn within 3 months prior to study treatment administration
- Unable to wear compression stockings
- History of heparin-induced thrombocytopenia or hypersensitivity to the LMWH and to the heparin or any other clinically significant contra-indications for use of LMWH
- Participation in bodybuilding or full time employment in a physically demanding occupation
- Immobilization, surgery, or traumatic injury of the arm within 90 days before first study treatment administration
- Traumatic injury of the leg within 6 months before first study treatment administration
- Immobilization or surgery of the leg within 6 months before first study treatment administration
- Immobilization of the leg for 2 or more weeks within 12 months before first study treatment administration
- Contraindication for MRI
- Habitual excessive over- or under-eating
- Any condition that may interfere with assessment of local pain and pruritus at the injection site
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04708847
Start Date
February 10 2021
End Date
February 1 2023
Last Update
February 17 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
QPS Netherlands B.V.
Groningen, Netherlands, 9713