NCT06537817

Study to Evaluate HT-4253 in Healthy Subjects

A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) of Oral HT-4253 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Halia Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple oral doses at escalating dose levels in healthy volunteer subjects. The secondary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of HT-4253.

Conditions

• Normal Healthy Subjects

Interventions

Type	Name	Description
DRUG	HT-4253	HT-4253 Single or Multiple doses administered orally as a tablet
DRUG	Placebo	Placebo to match HT-4253 Single or Multiple doses administered orally as a tablet

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-05-12
• Completion: 2025-05-12
• First posted: 2024-08-05
• Last updated: 2025-06-11

Locations

1 site across 1 country: Australia