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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT07108894
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female ≥ 18 and ≤ 65 years of age at the time of screening
* Good general health as determined through medical history and general physical examination
* Body weight ≥ 50 and ≤ 100 Kg
* Body mass index (BMI) between 18.5 kg/m2 and 30.0 kg/m2
* Non- or ex-smoker (an ex-smoker defined as someone who has completely stopped using nicotine products for at least 180 days prior to study drug administration)
* Meeting 1 of the following:
1. Is of childbearing potential or able to procreate and agrees to use an acceptable contraceptive method from at least 28 days prior to the screening visit through EOS visit
2. Is of nonchildbearing potential or unable to procreate
* If male, agrees not to donate sperm from the study drug administration through EOS visit; If female, agrees not to donate or retrieve eggs from the study drug administration through EOS visit
Exclusion Criteria:
* Pregnancy and/or lactation.
* Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or a seated blood pressure \< 90/50 mmHg or \> 140/90 mmHg
* eGFR \< 60 mL/min/1.73 m2
* Severe hypersensitivity reactions (like angioedema) to any drugs.
* Presence or history of significant gastrointestinal, liver disease, kidney disease, or surgery that may affect drug bioavailability.
* History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
* History or presence of multiple or severe drug allergies.
* Evidence of any active bacterial, viral, or fungal infection
* Disrupted skin integrity (apparent burn or dermatitis).
* History of syncope, palpitations, or unexplained dizziness.
* Use of prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration.
* Use of any over-the-counter products in the 7 days prior to study drug administration.
* Receipt of live vaccines within 5 weeks prior to screening or plans to receive live vaccines within 180 days after study drug administration.
* History of latent or active tuberculosis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07108894
Study Brief:
Protocol Section:
NCT07108894