NCT06780124

Сlinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers

An Exploratory Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE63-0302 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Eilean Therapeutics · 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 and multiple ascending doses of ZE63-0302 administered orally in healthy volunteers.

Detailed description

This is an exploratory Phase I, single- and multiple-dose escalation clinical trial conducted in healthy volunteers. The safety, tolerability, pharmacokinetics and pharmacodynamics of ZE63-0302 following oral administration in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design. This study will be subdivided into two parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. Healthy volunteers (BMI ≥ 18.5 and ≤ 32.0 kg/m2) and healthy volunteers with a high BMI (≥ 30.0 and ≤ 35.0 kg/m2) will be enrolled to receive single ascending doses (SAD) of ZE63-0302 or placebo under fasted or fed conditions, depending on the cohort, and healthy volunteers (BMI ≥ 18.5 and ≤ 32.0 kg/m2) will receive multiple ascending doses (MAD) of ZE63-0302 or placebo under fasted or fed conditions, depending on the cohort. The starting dose will be 20 mg with up to 7 SAD and 4 MAD cohorts planned. Sentinel dosing will be utilized in SAD Cohorts 1 to 4.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ZE63-0302 or placebo	The participants will receive ZE63-0302 or placebo

Timeline

• Start date: 2024-04-12
• Primary completion: 2025-06-24
• Completion: 2025-11-07
• First posted: 2025-01-17
• Last updated: 2026-01-22

Locations

1 site across 1 country: Australia