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Completed

NCT Number: NCT06537817

Study to Evaluate HT-4253 in Healthy Subjects

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.

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Key information

Conditions

Normal Healthy Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HT-4253

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: up to 6 weeks

    Incidence of adverse events (AEs)

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

    Time frame: up to 6 weeks

    Serious adverse events (SAEs)

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

    Time frame: up to 6 weeks

    Treatment-related adverse events (TRAEs)

  4. To evaluate the safety and tolerability of single and multiple ascending

    Time frame: up to 6 weeks

    Incidence of withdrawals due to AE

Secondary outcomes

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

    Time frame: up to 6 weeks

    Maximum plasma concentration (Cmax)

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

    Time frame: up to 6 weeks

    Area under the concentration-time curve (AUC)

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

    Time frame: up to 6 weeks

    Elimination half-life (t1/2) plasma concentration of HT-4253

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

    Time frame: up to 6 weeks

    Trough plasma concentration of HT-4253

Sponsors and collaborators

Lead sponsor

Halia Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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