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NOT YET RECRUITING
NCT07735728
PHASE1

A First-in-Human Study of ZE66-0205 in Healthy Volunteers

Sponsor: Eilean Therapeutics

View on ClinicalTrials.gov

Summary

This first-in-human study will evaluate ZE66-0205 in healthy adults. The main purpose is to assess the safety and tolerability of single oral doses and, if evaluated, two doses given on Day 1. The study will also assess how ZE66-0205 is absorbed, distributed, and eliminated from the body and how it affects MALT1 levels in blood cells. Participants will be assigned by chance to receive ZE66-0205 or placebo in sequential ascending-dose cohorts.

Official title: A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE66-0205 in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-08-15

Completion Date

2027-08-15

Last Updated

2026-07-30

Healthy Volunteers

Yes

Interventions

DRUG

ZE66-0205

ZE66-0205 oral soft gelatin capsules, 50 mg strength. Participants will receive the assigned total dose orally with approximately 240 mL of water. Planned nominal single-dose levels are 50 mg, 100 mg, 200 mg, and 300 mg. If twice-daily dosing is evaluated, a second dose will be administered approximately 12 hours after the morning dose.

DRUG

Placebo

Placebo formulation not containing the active drug

Locations (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia