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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT05027451
Eligibility Criteria:
Inclusion Criteria:
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Eligible participants will:
1. Be 18-65 years of age, inclusive, at the time of study consent;
2. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
3. Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations);
4. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
5. Be of nonchildbearing potential or agree to use protocol-specified method(s) of birth control throughout study participation;
6. Agree to adhere to Lifestyle Considerations throughout study duration.
Exclusion Criteria:
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Eligible participants will NOT:
1. Have a history of treatment with a monoclonal antibody in the past year;
2. Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other mAbs, any inactive ingredient of IXT-m200, or any other products required for the study procedures;
3. Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria;
4. Have a history of stimulant use, including methamphetamine and amphetamine;
5. Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);
6. Have a positive drug screen for any psychoactive substances (legal or nonlegal) on Day 1 prior to dosing;
7. Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;
8. Have a history of allergic or environmental bronchial asthma within the past 3 years;
9. Have a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous (eg psychiatric conditions), or hematologic systems, or recent clinically significant surgery;
10. Have a history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;
11. Have a planned or scheduled surgical procedure during the study;
12. Have recently donated blood or plasma (within 30 days of study drug dose);
13. Have a current diagnosis of anorexia nervosa or bulimia disorder;
14. Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;
15. Be pregnant or lactating;
16. In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05027451
Study Brief:
Protocol Section:
NCT05027451