Study to Evaluate HT-4253 in Healthy Subjects
- Registration Number
- NCT06537817
- Lead Sponsor
- Halia Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HT-4253 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. Placebo to match HT-4253 Placebo 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.
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults up to 6 weeks Treatment-related adverse events (TRAEs)
To evaluate the safety and tolerability of single and multiple ascending up to 6 weeks Incidence of withdrawals due to AE
- Secondary Outcome Measures
Name Time Method To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults up to 6 weeks Trough plasma concentration of HT-4253
Trial Locations
- Locations (1)
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia