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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT05353894
Eligibility Criteria:
Inclusion Criteria:
* BMI will be between 18 (inclusive) and 26 kg/m² (inclusive).
* Participants must be in good general health, with no significant medical history, have no clinically significant (CS) abnormalities on physical examination, vital signs, and 12-lead ECG at Screening and/or before administration of the first dose of study drug
* Have a Fridericia's correction factor for QT (QTcF) ≤ 450 ms for male participants and ≤ 470 ms for female participants on 12-lead ECG
* Women subjects of childbearing potential must have a negative serum/urine pregnancy test at screening and baseline
* Women subjects of childbearing potential and male subjects must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Able to understand and provide written informed consent.
Exclusion Criteria:
* Pregnant or breast-feeding mothers
* Known allergic reaction to quinolone derivatives (e.g., quinine, choloroquine, mefloquine)
* Subjects with any clinically significant laboratory abnormality
* History of QT prolongation (QTc ≥ 500 ms) or family history of long QT arrythmia or cardiac disease or bradycardia \< 50/mn or uncorrected hypokalemia
* On going uncontrolled infection disease
* History of pre-existing retinopathy or maculopathy
* Participation in any investigational clinical investigation ≤ 4 weeks prior to first planned dose of GNS561
* Malabsorption issues (e.g., gastric bypass or gastrectomy patients), current or history significant gastrointestinal diseases
* Patient with a mental or legal disability
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05353894
Study Brief:
Protocol Section:
NCT05353894