drugset / Trial / NCT06891287

An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers.

NCT06891287

Phase 1 Recruiting 60 enrolled RANI Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this Phase 1 study is to evaluate the safety and tolerability of RT-114 in healthy volunteers. The main objectives are: Primary: To evaluate safety and tolerability of RT-114 when administered as single and multiple doses by assessing treatment emergent adverse events (TEAEs) in healthy volunteers Secondary: * To determine the pharmacokinetics of RT-114 administered as single and multiple doses * To determine the pharmacodynamic effects of RT-114 administered as multiple doses In the single dose portion of the study participants will either receive the drug via a subcutaneous injection or an oral pill (RT-114). In the repeat dose portion of the study participants will randomized to either RT-114 or a placebo.

Timeline

Start
2025-12-30
Primary completion
2026-12-01
Completion
2027-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator PG-102 Monoclonal antibody Subcutaneous

Indications