NCT05447546

Study to Evaluate HT-6184 in Healthy Subjects

A Phase 1, Single-Center, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HT-6184 in Healthy Human Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Halia Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to evaluate the safety and tolerability of HT-6184 when administered as single 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-6184. Results of the PD analyses will be used to determine the minimal biologically effective dose (MBED): the lowest dose that achieves \>70% target inhibition compared to unstimulated vehicle controls over 24 hours in 4 of 6 treated volunteers.

Detailed description

This is a phase 1, randomized, placebo-controlled, single-center, single and multiple ascending dose study designed to evaluate the safety, tolerability, PK, and PD of HT-6184. Each cohort in the study will be comprised of 8 subjects, 6 subjects will receive HT-6184 and 2 subjects will receive placebo. A dose range of 1 mg - 4 mg HT-6184 will be explored in the SAD and MAD escalation cohorts in adult healthy volunteer subjects. Safety and PK data from the 8 completed cohorts will be reviewed. For the SAD portion subjects will be divided into 4 cohorts of 8 subjects in each cohort. Four (4) ascending single doses (1 dose level per cohort) will be investigated. Subjects will be screened for eligibility to participate in the study up to 26 days (Day -28) prior to admission to the study center on Day -2. Eligible subjects will be admitted to the study center on Day -2 and will be discharged on Day 2 after all scheduled assessments have been completed. Following discharge, subjects will return to the study center for follow-up visits on Day 7 and receive a follow-up phone call on Day 30. A modified Fibonacci escalation schedule starting at 1 mg, (escalating by 100%) 2 mg, (escalating by 50%) 3 mg, and (escalating by 33%) 4 mg. The study will have an ongoing assessment of all available safety, tolerability, and concentration data prior to initiation of the next cohort. For the MAD portion subjects will be divided into 4 cohorts of 8 subjects in each cohort. Four (4) ascending multiple doses (1 dose level per cohort) will be investigated. Subjects will be screened for eligibility to participate in the study up to 26 days (Day -28) prior to admission to the study center on Day -2. Eligible subjects will be admitted to the study center on Day -2 and will be discharged on Day 13 after all scheduled assessments have been completed. Following discharge, subjects will return to the study center for a follow-up visit on Day 21 and receive a follow-up phone call on Day 42.

Conditions

• Normal Healthy Subjects

Interventions

Type	Name	Description
DRUG	HT-6184	Oral capsule
DRUG	HT-6184 Placebo	Oral capsule

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-07-20
• Completion: 2023-07-20
• First posted: 2022-07-07
• Last updated: 2023-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study