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NOT YET RECRUITING
NCT06891287
PHASE1

An Early Phase Study of RT-114

Sponsor: RANI Therapeutics

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RT-114 in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-01

Completion Date

2026-04-01

Last Updated

2025-03-24

Healthy Volunteers

Yes

Conditions

Interventions

COMBINATION_PRODUCT

RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity

RT-114 is the RaniPill capsule with PG-102 for the treatment of obesity.

DRUG

PG-102

PG-102 is a drug for the treatment of obesity.

OTHER

Placebo

The placebo is the RaniPill with saline instead of a drug.