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A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
GYM329
Placebo
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 39 Years (Adult)MaleAccepts Healthy Volunteers

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
  • 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 Criteria:

  • 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

Sites / Locations

  • QPS Netherlands B.V.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pre-immobilization active drug group

Post-immobilization active drug group

Placebo group

Arm Description

Subjects will receive a single subcutaneous dose of GYM329 on Day 1 and a single subcutaneous dose of placebo on Day 15.

Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of GYM329 on Day 15.

Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of placebo on Day 15.

Outcomes

Primary Outcome Measures

Thigh muscle strength score
Percent change in thigh muscle strength score from Day 1 to Day 15 and 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 Outcome Measures

Safety; Adverse event monitoring
Incidence and severity of adverse events
Safety; Laboratory tests
Incidence of laboratory abnormalities, based on clinical laboratory tests
Safety; Vital signs
Abnormality in vital signs
Safety; Electrocardiogram (ECG)
Abnormality in Electrocardiograms (ECGs)
Pharmacokinetics; Serum GYM329 concentrations
Serum GYM329 concentrations over time
Pharmacokinetics; Cmax
Cmax of GYM329
Pharmacokinetics; Tmax
Tmax of GYM329
Pharmacokinetics; AUC
AUC of GYM329
Pharmacokinetics; T1/2
T1/2 of GYM329
Immunogenicity
Incidence of serum anti-GYM329 antibodies
Pharmacodynamics; Muscle volume
Changes in thigh muscle volume over time
Pharmacodynamics; Total and free latent myostatin, mature myostatin
Changes in total and free latent myostatin, mature myostatin over time

Full Information

First Posted
December 24, 2020
Last Updated
February 15, 2023
Sponsor
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04708847
Brief Title
A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-immobilization active drug group
Arm Type
Experimental
Arm Description
Subjects will receive a single subcutaneous dose of GYM329 on Day 1 and a single subcutaneous dose of placebo on Day 15.
Arm Title
Post-immobilization active drug group
Arm Type
Experimental
Arm Description
Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of GYM329 on Day 15.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of placebo on Day 15.
Intervention Type
Drug
Intervention Name(s)
GYM329
Intervention Description
GYM329 subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection
Primary Outcome Measure Information:
Title
Thigh muscle strength score
Description
Percent change in thigh muscle strength score from Day 1 to Day 15 and 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)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Safety; Adverse event monitoring
Description
Incidence and severity of adverse events
Time Frame
45 weeks
Title
Safety; Laboratory tests
Description
Incidence of laboratory abnormalities, based on clinical laboratory tests
Time Frame
45 weeks
Title
Safety; Vital signs
Description
Abnormality in vital signs
Time Frame
45 weeks
Title
Safety; Electrocardiogram (ECG)
Description
Abnormality in Electrocardiograms (ECGs)
Time Frame
45 weeks
Title
Pharmacokinetics; Serum GYM329 concentrations
Description
Serum GYM329 concentrations over time
Time Frame
45 weeks
Title
Pharmacokinetics; Cmax
Description
Cmax of GYM329
Time Frame
45 weeks
Title
Pharmacokinetics; Tmax
Description
Tmax of GYM329
Time Frame
45 weeks
Title
Pharmacokinetics; AUC
Description
AUC of GYM329
Time Frame
45 weeks
Title
Pharmacokinetics; T1/2
Description
T1/2 of GYM329
Time Frame
45 weeks
Title
Immunogenicity
Description
Incidence of serum anti-GYM329 antibodies
Time Frame
45 weeks
Title
Pharmacodynamics; Muscle volume
Description
Changes in thigh muscle volume over time
Time Frame
45 weeks
Title
Pharmacodynamics; Total and free latent myostatin, mature myostatin
Description
Changes in total and free latent myostatin, mature myostatin over time
Time Frame
45 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sponsor Chugai Pharmaceutical Co. Ltd
Organizational Affiliation
clinical-trials@chugai-pharm.co.jp
Official's Role
Study Director
Facility Information:
Facility Name
QPS Netherlands B.V.
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Learn more about this trial

A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer

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