Study to Evaluate HT-4253 in Healthy Subjects

NCT06537817 | Completed Phase 1

• 1 other identifier: HT-4253-NHV-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults

  Incidence of adverse events (AEs)

  up to 6 weeks

• To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults

  Serious adverse events (SAEs)

  up to 6 weeks

• To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults

  Treatment-related adverse events (TRAEs)

  up to 6 weeks

• To evaluate the safety and tolerability of single and multiple ascending

  Incidence of withdrawals due to AE

  up to 6 weeks

Secondary Outcomes (4)

• To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

  up to 6 weeks

• To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

  up to 6 weeks

• To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

  up to 6 weeks

• To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

  up to 6 weeks

Study Arms (2)

HT-4253

EXPERIMENTAL

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.

Drug: HT-4253

Placebo to match HT-4253

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

HT-4253 DRUG

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

HT-4253

Placebo DRUG

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

Placebo to match HT-4253

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Halia Therapeutics, Inc.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 5, 2024
• Study Start: September 17, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)