Status:
COMPLETED
Study to Evaluate HT-4253 in Healthy Subjects
Lead Sponsor:
Halia Therapeutics, Inc.
Conditions:
Normal Healthy Subjects
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 voluntee...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06537817
Start Date
September 17 2024
End Date
May 12 2025
Last Update
June 11 2025
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000