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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT04527718
Eligibility Criteria:
Inclusion Criteria:
1. Able to understand and willing to sign the ICF
2. Healthy male and female subjects, non-smokers, 18-55 years of age
3. In the opinion of the investigator, with no significant medical history, and in good health.
4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
5. Subjects are able to follow the study protocol and complete the trial.
Exclusion Criteria:
1. History of hypersensitivity to similar drugs to 611 or their excipients.
2. Pregnant, or nursing females.
3. HepBsAg or HepCAb positive.
4. Human immunodeficiency virus (HIV) positive.
5. Positive urine drug screen, or cotinine test.
6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04527718
Study Brief:
Protocol Section:
NCT04527718