Clinical trial
Safety Follow-up Study of Participants Dosed With INV-347 in Study INV-CL-108
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07153172
Recruiting nowPhase 1Interventional
What this study is about
The study looks at the safety and blood levels of the study drug INV-347 in participants who were previously dosed with INV-347 in study INV-CL-108. Participants will not get any study drug in this study as it looks into the safety of a drug previously dosed. The study will last until visit 21.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionObesity
Full registry criteria
Inclusion Criteria: 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male or female (sex at birth). 3. Age 18 years or above at the time of signing the informed consent. 4. Previously dosed with INV-347 in study INV-CL-108 and with measurable INV-347 concentration in plasma at enrolment \[above lower limit of qualification (LLOQ) of 0.5 nanogram per milliliter (ng/mL)\]. Exclusion Criteria: The study has no exclusion criteria.
Treatments and study arms
INV-347
Drug
Participants who were dosed with INV-347 in the First In Human study INV-CL-108 and still have measurable plasma exposure of INV-347 are included to assess long term safety.
Primary outcomes
Number of adverse eventsFrom the end-of-study participation in INV-CL-108 (week 0) to completion of the end-of-study visit (up to week 104 from enrolment)
Number of events
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Syneos Health Clinique🇨🇦 Québec, Canada