MedTrace Logo

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

NCT07735728 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-14

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers (HV)

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

Sponsors & Collaborators

  • Eilean Therapeutics

    lead INDUSTRY

Principal Investigators

  • Ekaterina Dokukina · Eilean Therapeutics AU Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2027-08-15
Completion
2027-08-15

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735728 on ClinicalTrials.gov