A Randomized, Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Epi/Intra-dermally Administered Semaglutide (VX-201) Compared to Subcutaneous Administration in Healthy Overweight and Obese Participants: Single and Multiple Dose Assessment
Terrestrial Bio, Inc.
Summary
VX-201-101 is a first-in-human Phase 1 clinical study evaluating VX-201, a needle-free microneedle (MN) array patch (MAP) that delivers semaglutide through the skin as an alternative to subcutaneous (SC) injection.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * To be eligible for study participation, all subjects must meet all the following inclusion criteria: 1. Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or urinalysis at Screening and Day -1 (SAD)/Day 0 (MD) as deemed by the Investigator 2. Age 18 to 60 years, inclusive, at the time of Screening 3. Body mass index ≥25 to \<35 kg/m2 if participating in the SAD phase or ≥27 to \<40 kg/m2 if participating in the MD phase, at the time of Screening 4. Must be able to communicate…
Interventions
- Combination ProductVX-201
VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally
- Drugsemaglutide SC
Semaglutide is a long acting GLP-1 analogue with low renal clearance and an elimination half-life of approximately 7 days following subcutaneous administration.
Location
- Celerion Clinical ResearchTempe, Arizona