Study to Evaluate HT-4253 in Healthy Subjects

Halia Therapeutics, Inc.80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Normal Healthy Subjects

Interventions

HT-4253DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults

Incidence of adverse events (AEs)

Time frame: up to 6 weeks

To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults

Serious adverse events (SAEs)

Time frame: up to 6 weeks

To evaluate the safety and tolerability of single and multiple ascending doses of oral HT-4253 in healthy adults

Treatment-related adverse events (TRAEs)

Time frame: up to 6 weeks

To evaluate the safety and tolerability of single and multiple ascending

Incidence of withdrawals due to AE

Time frame: up to 6 weeks

Secondary Outcomes

To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

Maximum plasma concentration (Cmax)

Time frame: up to 6 weeks

To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

Area under the concentration-time curve (AUC)

Time frame: up to 6 weeks

To evaluate the plasma pharmacokinetics (PK) of single and multiple ascending doses of oral HT-4253 in healthy adults

Elimination half-life (t1/2) plasma concentration of HT-4253

Time frame: up to 6 weeks

Data from ClinicalTrials.gov

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