NCT07146191

RE104 Radiolabeled Mass Balance (hAME) Study

A Phase 1, Open-label, Single Period Study to Evaluate the Absorption, Metabolism, and Excretion of a Single Microdose of [14C]-RE104 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Reunion Neuroscience Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers. This study will quantify drug and metabolites in blood, urine, and feces samples collected before study drug administration and through at least 168 hours after SC dosing of \[14C\]-RE104.

Conditions

• Healthy Participant Study

Interventions

Type	Name	Description
DRUG	2-[14C]-RE104 for Injection	Single, subcutaneous dose of 2-\[14C\]-RE104 for Injection

Timeline

• Start date: 2025-08-19
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2025-08-28
• Last updated: 2025-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study