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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT04698694
Eligibility Criteria:
Inclusion Criteria:
1. Signed and dated informed consent obtained before undergoing any study-specific procedure
2. Healthy subjects, as determined by a responsible physician, based on a medical evaluation including medical history and physical examination
3. Males or females aged ≥18 and ≤ 55 years
4. A minimum weight of 50 kg and Body Mass Index \>18.5 and ≤30 kg/m2
5. Vital signs within the following values or ranges:
1. Body temperature ≤ 37,5 °C
2. Pulse frequency ≥51 and ≤100 beats per minute
3. Diastolic BP ≥60 mmHg, ≤ 90 mmHg
4. Systolic BP ≥ 90 mmHg, ≤ 140 mmHg
6. Normal ECG
7. CPK within normal reference range
8. Non-pregnant women of childbearing potential, non-breastfeeding
9. Able and willing to comply with all study procedures.
Exclusion Criteria:
1. Any past or present cardiac disease, even if not evident at ECG
2. Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor deficiency) or prior history of significant bleeding or bruising following IM injections or venepuncture
3. History of seizures or mental illness
4. Metal implants within 20 cm of the planned site(s) of injection
5. Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
6. Any abnormality or permanent body art (e.g. tattoos) that would interfere with the ability to observe local reactions at the injection site in the deltoid area
7. History of alcohol or drug abuse during the 12 months preceding the screening
8. Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
9. Breastfeeding
10. Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
55 Years
Study:
NCT04698694
Study Brief:
Protocol Section:
NCT04698694