Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT06785428
Eligibility Criteria:
Inclusion Criteria:
* Adult female or male participants who are 26 to 60 years of age at screening (inclusive)
* Genetically confirmed with FSHD
* Ambulatory
* Has maintained stable use of medication and supplements, stable dietary and lifestyle habits, and stable body weight, for the last 3 months prior to screening and agree to maintain them throughout the study
* Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures
Exclusion Criteria:
* Individuals who are lactating or pregnant
* Usage of corticosteroids within 3 months of study entry or had ever taken steroids for a duration exceeding 1 year
* On androgens or growth hormone within 6 months before screening and for duration of study; topical physiologic androgen replacement is permitted
* On sympathomimetic agents, antidepressants, or β-receptor blockers
* Have cardiovascular disease
* Evidence of an alternative diagnosis other than FSHD or a coexisting myopathy or dystrophy
* Current/active malignancy (e.g., remission less than 5 years' duration), with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin
* Type 1 or type 2 diabetes mellitus
* History of sensitivity to protein pharmaceuticals
* Known active substance abuse, including alcohol
* Renal impairment (serum creatinine ≥ 2 times the upper limit of normal,(ULN))
* History of severe restrictive or obstructive lung disease, or evidence for interstitial lung disease on screening chest radiograph
* Major surgery within 4 weeks prior to metabolic trial 1
* Any other active or unstable medical/psychological conditions or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
26 Years
Maximum Age:
60 Years
Study:
NCT06785428
Study Brief:
Protocol Section:
NCT06785428