NCT05979727

Dose-finding PKPD Trial for RE02 in Healthy Subjects

Double-blind, Randomized, Dose-response Study of RE02 in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Reconnect Labs · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability of three different doses against a placebo control.

Detailed description

Participants will undergo a series of four study days with varying doses of RE02 and a placebo. The intervention is embedded in controlled environment and continuous psychological support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 6 hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction. Additionally, the occurrence of adverse events will be closely monitored throughout the whole study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RE02	Low, medium or high dose of RE02
DRUG	Manitol	Placebo Comparator

Timeline

• Start date: 2023-11-20
• Primary completion: 2023-12-10
• Completion: 2023-12-10
• First posted: 2023-08-07
• Last updated: 2024-11-27

Locations

1 site across 1 country: Switzerland