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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

NCT06787131 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Lomond Therapeutics Holdings, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2025-07-04
Completion
2025-07-04

Countries

  • Australia

Study Locations

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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 NCT06787131 on ClinicalTrials.gov