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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT05388903
Eligibility Criteria:
Inclusion Criteria:
* Participants must give written informed consent to participation in the study prior to Screening
* Healthy men and women 18 to 45 years of age (inclusive), with a BMI of 18 kg/m2 to 30 kg/m\^2 (inclusive) at Screening
* All women must have a negative serum pregnancy test at Screening and all women of childbearing potential must have a negative urine pregnancy test on Day -1
* Women must not be lactating during the study treatment period and for 3 months after the last dose of study treatment
* Women of childbearing potential must practice effective contraception during the study treatment period and for 3 months after the last dose of study treatment. They must agree to use 2 different means of nonhormonal contraceptive methods
* Women of non-childbearing potential must be either surgically sterile (ie, bilateral tubal ligation at least 3 months prior to dosing) or in menopausal state confirmed as follows: 1 year of spontaneous amenorrhea without an alternative medical cause and a serum FSH level ≥40 mIU/mL
* Men must agree to use contraception (condom with spermicide) during the study treatment period and for at least 3 months after the last dose of study treatment or be surgically sterile (vasectomy at least 3 months prior to dosing)
* Women should not donate eggs and men should not donate sperm during the study treatment period and for at least 3 months after the last dose of study treatment
* Participants must be in good health as determined by Screening medical history, physical examination, vital signs, ECGs, serum chemistry, hematology, virology, and urinalysis performed at Screening and on Day -1
Exclusion Criteria:
* History or current chronic lung disease including asthma, chronic obstructive pulmonary disease (COPD), or heavy smoking of \>10 pack years
* Previous or current treatment with systemic corticosteroids or any immunosuppressive agents
* Participants who have received a transfusion or any blood products within the last year prior to dosing
* Participants who have made any blood donation or have had a loss of blood of ≥500 mL within 56 days prior to the dose of study drug
* Participants who consume more than 21 units of alcohol per week (1 unit of alcohol equals 1/2 pint of beer, 4 ounces of wine, or 1 ounce of spirits) or those participants who have a significant history of alcoholism or drug/chemical abuse within the last 2 years.
* Participants with positive results on tests for drugs of abuse, cotinine, or alcohol at Screening and/or Day -1.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05388903
Study Brief:
Protocol Section:
NCT05388903