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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05156034
Eligibility Criteria:
Inclusion Criteria:
* Participants who have clinical chemistry laboratory values within the acceptable range for the population, as per the investigator judgment
* Body mass index of 18 to 32 kilogram (kg)/ square meter (m\^2)
* Healthy male participants
1. Nonvasectomized male participants must agree to abstain from sexual intercourse or use a condom as well as 1 additional highly effective method of contraception (less than \[\<\]1 percent \[%\] failure rate) or effective method of contraception with all sexual partners of childbearing potential during the study and for 90 days following the last dose of study intervention
2. Must agree not to donate sperm from start of dosing until 90 days beyond the last dose of study intervention
3. No restrictions are required for a vasectomized male
* Healthy female participants of childbearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from screening to 90 days after the last dose of the study intervention. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method:
1. hormonal contraceptives (oral, transdermal patches, vaginal, or injectable)
2. intrauterine device with or without hormones
3. condom, diaphragm, or cervical cap ('barrier' method)
4. sexual abstinence, and
5. vasectomized partner
* Has been fully vaccinated for COVID-19 with the last dose of vaccine administered at least 3 weeks prior to study intervention administration
Exclusion Criteria:
* For at least 30 days prior to randomization, participants must have no symptoms and/or signs of confirmed or suspected infection (including COVID-19) and must have completed any appropriate anti-infective treatment
* Have any concomitant systemic disorder, human immunodeficiency virus (HIV) infection, current infection with hepatitis B virus (HBV) (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA, hepatitis C virus (HCV) (that is, positive for HCV ribo nucleic acid\[RNA\]), symptomatic herpes zoster within 6 months prior to screening, an eye condition currently requiring treatment for trauma, contact allergy, postsurgical, or conjunctivitis that may interfere with eye evaluations, active or latent tuberculosis (TB)
* Are currently enrolled in or have participated in greater than (\>) 4 clinical trials in the past 12 months involving a study intervention or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study or have received a. any nonbiologic IP within 30 days or 5 half-lives (whichever is longer) of their baseline (Day -1) visit, or b. any biologic IP within 3 months or 5 half-lives (whichever is longer) of their baseline (Day -1) visit
* Have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing (1 unit = 12 ounce \[oz\] or 360 milliliter \[mL\] of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
* Drug abuse in the past 12 months and/or show positive findings on drug screening unless they were prescribed by a physician (for example, benzodiazepines)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05156034
Study Brief:
Protocol Section:
NCT05156034