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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06537817

Enrollment

Registered

2024-08-05

Start date

2024-09-17

Completion date

2025-05-12

Last updated

2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Healthy Subjects

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.

Interventions

DRUGHT-4253

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults	up to 6 weeks	Incidence of adverse events (AEs)
To evaluate the safety and tolerability of single and multiple ascending	up to 6 weeks	Incidence of withdrawals due to AE

Secondary

Measure	Time frame	Description
To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults	up to 6 weeks	Maximum plasma concentration (Cmax)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026