NCT06399315

Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Lomond Therapeutics Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug

Detailed description

This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered ZE46-0134 in Healthy Volunteers. The study will be conducted in 2 parts: a single ascending dose (SAD) part at up to 6 dose levels and a multiple ascending dose (MAD) part at up to 5 dose levels. 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 ZE46-0134 and the other randomised to receive placebo. The food-effect will be investigated in SAD part and safety/PK of co-administration with rabeprazole will be investigated in MAD part.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	ZE46-0134 or placebo	The patients will receive ZE46-0134 or placebo
DRUG	Rabeprazole, 20mg oral	Rabeprazole 20 mg daily will be administered for 2 prior ZE46-0134 and 7 co-administered
DRUG	Itraconazole (200 mg)	Itraconazole 200 mg BID

Timeline

• Start date: 2023-07-28
• Primary completion: 2025-06-30
• Completion: 2025-08-26
• First posted: 2024-05-03
• Last updated: 2025-12-09

Locations

1 site across 1 country: Australia