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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT04208061
Eligibility Criteria:
Inclusion Criteria:
* Must have a body mass index (BMI) (weight in kilogram \[kg\]/height\^2 in square meters \[m\^2\] ) between 18.0 and 30.0 kg/m\^2 (inclusive) and body weight not less than 50.0 kg
* Must sign an informed consent form (ICF) indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study
* A woman must have a negative highly sensitive serum beta human chorionic gonadotropin (beta hCG) pregnancy test at screening, on Day -1 (only if the test performed at screening was greater than \[\>\] 4 days before dosing), and at the end of the study
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after receiving the last dose of study drug
* Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug
Exclusion Criteria:
* Clinically significant abnormalities during physical examination, vital signs, or 12 lead - electrocardiogram (ECG) at screening as deemed appropriate by the investigator
* With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* With a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
* Has donated blood or blood products or had substantial loss of blood (more than 500 milliliter \[mL\]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
* Has received an investigational drug or used an investigational medical device within 60 days before the first intake of study drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04208061
Study Brief:
Protocol Section:
NCT04208061