Clinical trial NCT06537817: Study to Evaluate HT-4253 in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Healthy Subjects
Lead sponsor: Halia Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
measure: To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
measure: To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
measure: To evaluate the safety and tolerability of single and multiple ascending
timeFrame: up to 6 weeks
Secondary outcomes:
measure: To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
measure: To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
measure: To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
measure: To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
References: