Evaluating HT-4253 in healthy volunteers
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
This study is testing a new drug called HT-4253 in healthy volunteers to see if it's safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Halia Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT06537817 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of HT-4253 through single and multiple oral doses in healthy subjects. It will also investigate the pharmacokinetics and pharmacodynamics of the drug. Participants will receive either HT-4253 or a placebo, with escalating dose levels to determine the appropriate dosage and effects. The study is designed to ensure that the drug is safe for future use in broader populations.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a body mass index between 18 and 32 kg/m2.
Not a fit: Patients with significant medical conditions or those taking medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new treatment option that is safe for use in healthy individuals.
How similar studies have performed: Other studies evaluating similar pharmacological agents have shown success in establishing safety and tolerability, making this approach a standard practice in early-phase drug development.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Adelaide, South Australia
- CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Medical Monitor
- Email: monitor@haliatx.com
- Phone: 385-355-4315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.