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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT05074459
Eligibility Criteria:
Key Inclusion Criteria:
* The participant has a body weight ≥50 and ≤100 kilograms (kg).
* The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/meter (m\^2) at the screening visit and at the baseline visit.
* The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the screening visit and at the baseline visit.
* The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the screening visit and at the baseline visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key Exclusion Criteria:
* The participant has taken disallowed medication \<1 week prior to the dose of investigational medicinal product (IMP) or \<5 half-lives prior to the screening visit for any medication taken.
* The participant has taken any IMP \<3 months or \<5 half-lives (whichever is longer) prior to the first dose of IMP.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has been dosed with a monoclonal antibody (mAb) ≤6 months prior to the screening visit.
* The participant is a smoker or uses other nicotine-containing products (for example, snuff, nicotine patches, nicotine chewing gum, mock cigarettes, inhalers). Ex-smokers must have ceased smoking \>3 months prior to the screening visit.
Other inclusion and exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05074459
Study Brief:
Protocol Section:
NCT05074459