Study to Evaluate HT-4253 in Healthy Subjects

NCT ID: NCT06537817

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2025-05-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

HT-4253

Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 6 subjects will receive HT-4253.

Group Type: EXPERIMENTAL

HT-4253

Intervention Type: DRUG

HT-4253 Single or Multiple doses administered orally as a tablet

Placebo to match HT-4253

Subjects will participate in 1 of 10 groups and receive single or multiple doses of HT-4253 or matching placebo. In each group 2 subjects will receive matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match HT-4253 Single or Multiple doses administered orally as a tablet

Interventions

HT-4253

HT-4253 Single or Multiple doses administered orally as a tablet

Intervention Type: DRUG

Placebo

Placebo to match HT-4253 Single or Multiple doses administered orally as a tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age is ≥ 18 years to 65 years
• Body mass index between 18 and 32 kg/m2
• Female subjects must be surgically sterile or post menopausal for at least 12 months. Females may be of child-bearing potential but must use double contraception.

Exclusion Criteria

• Any clinically significant central nervous system, cardiac, pulmonary, renal, gastrointestinal, endocrinological, respiratory, or metabolic conditions (or history), or other pathological or physiological conditions,
• History of suicidal behavior and/or ongoing suicidal ideation per C-SSRS evaluation when screening
• Use of any medications, including prescription, over-the-counter (OTC) medications, vitamins, herbal preparations, and supplements
• Positive drug screen or alcohol breath tests
• History of heavy smoking more than 10 cigarettes a day or the tobacco/nicotine equivalent within 3 months of Screening or refuses to abstain from tobacco or nicotine-containing products throughout the duration of the study
• Clinical significant abnormalities in laboratory test results
• Chronic or current active infectious disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Halia Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMAX Clinical Research

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

HT-4253-NHV-001

Identifier Type: -

Identifier Source: org_study_id