NCT06787131

Clinical Study Aiming to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Administration of ZE50-0134 at 5 Dose Levels in Healthy Volunteers

A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE50-0134 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Lomond Therapeutics Holdings, Inc. · 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 ZE50-0134 administered orally in healthy volunteers.

Detailed description

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single administration of ZE50-0134 at 5 dose levels. The effect of food on ZE50-0134 may also be evaluated at each dose level (optional). The effects of CYP3A4 inhibition will also be evaluated in a single cohort. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. In this study, healthy volunteers will be enrolled to receive single ascending doses of ZE50-0134 or placebo under fasted or fed conditions. ZE50-0134 will also be evaluated in conjunction with itraconazole, to evaluate the potential effects of CYP3A4 inhibition. The starting dose will be 100 mg with 5 dose levels planned.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ZE50-0134 or placebo	The patients will receive ZE50-0134 or placebo.
DRUG	Rabeprazole 20 mg	Rabeprazole 20 mg once daily (QD) on Day 1 and Day 2.
DRUG	Itraconazole (200 mg)	Itraconazole 200 mg twice per day.

Timeline

• Start date: 2024-05-21
• Primary completion: 2025-07-04
• Completion: 2025-07-04
• First posted: 2025-01-22
• Last updated: 2025-12-05

Locations

1 site across 1 country: Australia