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

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.

Study Overview

• Status: Completed
• Conditions: Normal Healthy Subjects
• Intervention / Treatment: Drug: HT-4253; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: HT-4253; HT-4253 Single or Multiple doses administered orally as a tablet
Placebo Comparator: 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.	Drug: Placebo; Placebo to match HT-4253 Single or Multiple doses administered orally as a tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults	Maximum plasma concentration (Cmax)	up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults	Area under the concentration-time curve (AUC)	up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults	Elimination half-life (t1/2) plasma concentration of HT-4253	up to 6 weeks
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults	Trough plasma concentration of HT-4253	up to 6 weeks

Collaborators and Investigators

• Sponsor: Halia Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HT-4253-NHV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No