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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT05787002
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
* Females must have a negative pregnancy test at screening and must not be lactating
* Participants with BMI between 18 and 30 kg/m\^2, inclusive, and weighing between 50 kg and 100 kg, inclusive
Exclusion Criteria:
* History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization and second vaccination within 10 days of screening
* Confirmed Coronavirus disease 2019 (COVID-19) infection at admission, by Polymerase chain reaction (PCR) test
* Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
* History or presence of severe allergy/hypersensitivity
* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening
* Positive screen for drugs of abuse, alcohol, or cotinine at screening
* Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug
* Any clinically significant abnormalities in clinical chemistry, hematology, coagulation, urinalysis results, ECG or vital signs
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05787002
Study Brief:
Protocol Section:
NCT05787002