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Study to Evaluate HT-4253 in Healthy Subjects

NCT06537817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-06-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Halia Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-05-12
Completion
2025-05-12

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT06537817 on ClinicalTrials.gov