NCT06667765

A Study of RPT1G After Single and Multiple Doses in Healthy Adult Participants

A Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RPT1G After Single and Multiple Doses in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Remedy Plan, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single and multiple dose study with staggered dose escalations in healthy participants.

Detailed description

Single-Ascending Dose (SAD) Cohorts: Cohorts 1-4: Up to 32 participants will be enrolled in this arm. On Day 1, all participants will receive a single oral dose of RPT1G or placebo, in the fasted state, as well as post-dose safety, PK, and PD assessments up to Day 4 (72 hours post-dose). Multiple-Ascending Dose (MAD) Cohorts: Cohorts 5-7: Up to 18 participants will be enrolled in this arm. On Day 1, all participants will begin twice daily (BID \[i.e., every 12 hours\]) multiple oral dose administration of RPT1G or placebo in the fasted state for 5 days as well as safety, PK, and/or PD assessments throughout the study intervention administration period and up to Day 8 (72 hours after last dose).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RPT1G	Dose formulation- Oral capsule
DRUG	Placebo	Dose formulation- Oral capsule

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2024-10-31
• Last updated: 2025-09-02

Locations

1 site across 1 country: Australia