NCT07527221

Safety and Tolerability of ZE74-0282 in Healthy Volunteers

A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE74-0282 in Healthy Volunteers.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Eilean Therapeutics AU Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses under fasted and fed conditions of ZE74-0282 administered orally in healthy volunteers.

Detailed description

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single administration of ZE74-0282 at 5 dose levels in healthy volunteers. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Dosing in each cohort will start with two sentinel participants with one of the two sentinels randomised to receive ZE74-0282 and the other randomised to receive placebo. The safety and tolerability of each sentinel participant will be monitored in the clinic until Day 3 and will be reviewed prior to dosing the remainder of participants in each cohort.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ZE74-0282-0001 or placebo	The participant will receive ZE74-0282-0001 or placebo

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-11-01
• Completion: 2027-01-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Australia