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:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT05882695
Eligibility Criteria:
Inclusion Criteria:
* Age 18-55
* Must be in good health with no significant medical history
* Clinical laboratory values within normal range or \< 1.2 times ULN
* BMI 18-32 (inclusive)
* Contraceptive use by men or women consistent with local regulations
* Able and willing to provide written informed consent
Exclusion Criteria:
* Any physical or psychological condition that prohibits study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection within 1 month of screening
* Acute illness within 30 days of Day 1
* Surgery, bone fracture, or major musculoskeletal injury in the past 3 months
* History of suicidal behavior or suicidal ideation
* Active cigarette smokers and users of nicotine-containing products
* HIV, hepatitis B and hepatitis C positive
* SBP \>140 or \<90
* DBP \>90 or \<40
* HR \<40 or \>100
* QTcF \>450ms, cardiac arrhythmia, or clinically significant abnormal ECG
* Prescriptions, over-the-counter, or herbal medication within 7 days
* Vaccines within 14 days
* Other investigational products within 30 days
* Blood donation within 30 days
* Plasma donation within 7 days
* Pregnant or breastfeeding
* Otherwise unfit, on metabolic-altering lifestyle/diet, positive urine drug screen or intake of alcohol or caffeine-containing products
ALS Cohort Inclusion Criteria:
* Age 18-80
* ALS TRICALS risk score
* Stable dose of standard of care treatment
* Contraception use by men or women consistent with local regulations
* Able and willing to provide written informed consent
ALS Cohort Exclusion Criteria:
* Underlying physical or psychological condition prohibiting study completion
* Known cardiac disease
* Active or history of malignancy in the past 5 years
* Serious infection within 1 month of screening
* Acute illness within 30 days of Day 1
* History of suicidal behavior or suicidal ideation
* Active cigarette smokers and users of nicotine-containing products
* Neurodegenerative disease
* External respiratory support or supplemental oxygen requirement
* HIV, hepatitis B and hepatitis C positive
* SBP \>140 or \<90
* DBP \>90 or \<40
* HR \<40 or \>100
* QTcF \>450ms, cardiac arrhythmia, or clinically significant abnormal ECG
* Vaccines within 14 days
* Other investigational products within 30 days
* Blood donation within 30 days
* Plasma donation within 7 days
* Pregnant or breastfeeding
* Otherwise unfit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05882695
Study Brief:
Protocol Section:
NCT05882695