Healthy VolunteersPhase 1NCT04708847
A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer
A Phase 1 study testing GYM329 in people with Healthy Volunteers, run by Chugai Pharmaceutical at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GYM329
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2021to 1 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Healthy Volunteers
- Being tested
- GYM329, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GYM329Drug
GYM329 subcutaneous injection
PlaceboDrug
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Pre-immobilization active drug group | Experimental | Subjects will receive a single subcutaneous dose of GYM329 on Day 1 and a single subcutaneous dose of placebo on Day 15. Receives: Drug: GYM329 |
| Post-immobilization active drug group | Experimental | Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of GYM329 on Day 15. Receives: Drug: GYM329 |
| Placebo group | Placebo comparator | Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of placebo on Day 15. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Secondary outcomes (12)
Safety; Adverse event monitoring
Incidence and severity of adverse events
Measured: 45 weeks
Safety; Laboratory tests
Incidence of laboratory abnormalities, based on clinical laboratory tests
Measured: 45 weeks
Safety; Vital signs
Abnormality in vital signs
Measured: 45 weeks
Safety; Electrocardiogram (ECG)
Abnormality in Electrocardiograms (ECGs)
Measured: 45 weeks
Pharmacokinetics; Serum GYM329 concentrations
Serum GYM329 concentrations over time
Measured: 45 weeks
Pharmacokinetics; Cmax
Cmax of GYM329
Measured: 45 weeks
Pharmacokinetics; Tmax
Tmax of GYM329
Measured: 45 weeks
Pharmacokinetics; AUC
AUC of GYM329
Measured: 45 weeks
Pharmacokinetics; T1/2
T1/2 of GYM329
Measured: 45 weeks
Immunogenicity
Incidence of serum anti-GYM329 antibodies
Measured: 45 weeks
Pharmacodynamics; Muscle volume
Changes in thigh muscle volume over time
Measured: 45 weeks
Pharmacodynamics; Total and free latent myostatin, mature myostatin
Changes in total and free latent myostatin, mature myostatin over time
Measured: 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start10 Feb 2021
- Primary completion3 Jun 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708847
- Sponsor's protocol ID
- JP42791
- Status last verified
- Feb 2023
- First submitted
- 24 Dec 2020
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04708847
- Acronym / sponsor ID
- JP42791
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-immobilization active drug group | Experimental | Drug: GYM329Subjects will receive a single subcutaneous dose of GYM329 on Day 1 and a single subcutaneous dose of placebo on Day 15. |
| Post-immobilization active drug group | Experimental | Drug: GYM329Subjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of GYM329 on Day 15. |
| Placebo group | Placebo comparator | Drug: PlaceboSubjects will receive a single subcutaneous dose of placebo on Day 1 and a single subcutaneous dose of placebo on Day 15. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GYM329GYM329 subcutaneous injection | Drug | Post-immobilization active drug group, Pre-immobilization active drug group |
| PlaceboPlacebo subcutaneous injection | Drug | Placebo group |
Primary outcome
Thigh muscle strength score
Time frame: 28 days
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)
12 secondary outcomes
Safety; Adverse event monitoring
Time frame: 45 weeks
Safety; Laboratory tests
Time frame: 45 weeks
Safety; Vital signs
Time frame: 45 weeks
Safety; Electrocardiogram (ECG)
Time frame: 45 weeks
Pharmacokinetics; Serum GYM329 concentrations
Time frame: 45 weeks
Pharmacokinetics; Cmax
Time frame: 45 weeks
Pharmacokinetics; Tmax
Time frame: 45 weeks
Pharmacokinetics; AUC
Time frame: 45 weeks
Pharmacokinetics; T1/2
Time frame: 45 weeks
Immunogenicity
Time frame: 45 weeks
Pharmacodynamics; Muscle volume
Time frame: 45 weeks
Pharmacodynamics; Total and free latent myostatin, mature myostatin
Time frame: 45 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: Yes. 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).
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GYM329 in people with Healthy Volunteers, run by Chugai Pharmaceutical at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh muscle strength score (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.