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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT06304961
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female participants aged 18 to 55 years.
* All females must have a negative pregnancy test at the screening visit and on admission to the Clinical Unit.
* Females of childbearing potential must not be lactating and, if heterosexually active, must agree to use an approved method of highly effective contraception.
* Females of non-childbearing potential must be confirmed at the screening visit.
* Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
* Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 55 kg and no more than 100 kg inclusive.
* Intact normal skin without potentially obscuring tattoos, scars, etc, at the injection site.
Exclusion Criteria:
* History of any clinically significant disease or disorder (including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator).
* Any clinically significant abnormal findings in vital signs at the screening visit and/or admission (Day -1) to the Clinical Unit, as judged by the investigator.
* Any clinically significant abnormalities on 12-lead ECG at the screening visit and/or admission (Day -1) to the Clinical Unit, as judged by the investigator.
* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 6 months prior to the screening visit, as judged by the investigator.
* Any clinically important illness, medical/surgical procedure, or trauma within 8 weeks of the screening visit, or any planned inpatient surgery or hospitalisation during the study period.
* Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to enrolment. Suspected malignancy or undefined neoplasms.
* Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
* Any laboratory values with the following deviations at the screening visit or on admission (Day -1) to the Clinical Unit.
* Any clinically significant abnormal findings in physical examination at screening and/or admission (Day -1), which, in the opinion of the investigator, may put the participant at risk because of their participation in the study or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
* History of known immunodeficiency disorder, including a positive test for Human immunodeficiency virus-1 (HIV-1) or HIV-2.
* History or treatment for hepatitis B or hepatitis C or any positive test result on screening for Hepatitis B surface antigen (HBsAg), anti- Hepatitis B core (HBc) antibodies, or anti-hepatitis C antibodies.
* Evidence of active or latent Tuberculosis (TB).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06304961
Study Brief:
Protocol Section:
NCT06304961