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Unknown

3 mg HT-6184 QD for Normal Healthy Subjects

Phase 1
Waitlist Available
Led By Jesson Yeh, MD
Research Sponsored by Halia Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks

Summary

This trial tests a new drug, HT-6184, for safety and tolerability in healthy volunteers. Researchers aim to understand how the body processes the drug and its effects. The goal is to ensure the drug is safe before further testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of abnormal laboratory test results
Incidence of adverse events administered as single oral doses at escalating dose levels in healthy volunteer subjects.
Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
+1 more
Secondary study objectives
Apparent clearance (CL/F)
Apparent volume of distribution at steady state (Vss/F)
Area under the plasma concentration-time curve (AUC0-24)
+6 more

Trial Design

16Treatment groups
Active Control
Placebo Group
Group I: 3 mg HT-6184 QDActive Control1 Intervention
Cohort 3 - 6 subjects x 3 mg HT-6184 QD on Day 1
Group II: 4 mg HT-6184 QDActive Control1 Intervention
Cohort 4 - 6 subjects x 4 mg HT-6184 QD on Day 1
Group III: 1 mg HT-6184 QD x 2 weeksActive Control1 Intervention
Cohort 5 - 6 subjects x 1 mg HT-6184 QD on Day 1-5, 8-12
Group IV: 2 mg HT-6184 QD x 2 weeksActive Control1 Intervention
Cohort 6 - 6 subjects x 2 mg HT-6184 QD on Day 1-5, 8-12
Group V: 4 mg HT-6184 QD x 2 weeksActive Control1 Intervention
Cohort 8 - 6 subjects x 4 mg HT-6184 QD on Day 1-5, 8-12
Group VI: 3 mg HT-6184 QD x 2 weeksActive Control1 Intervention
Cohort 7 - 6 subjects x 3 mg HT-6184 QD on Day 1-5, 8-12
Group VII: 1 mg HT-6184 QDActive Control1 Intervention
Cohort 1 - 6 subjects x 1 mg HT-6184 QD on Day 1
Group VIII: 2 mg HT-6184 QDActive Control1 Intervention
Cohort 2 - 6 subjects x 2 mg HT-6184 QD on Day 1
Group IX: 1 mg Placebo QDPlacebo Group1 Intervention
Cohort 1 - 2 subjects x placebo, QD on Day 1
Group X: 3 mg Placebo QDPlacebo Group1 Intervention
Cohort 3 - 2 subjects x placebo, QD on Day 1
Group XI: 4 mg Placebo QDPlacebo Group1 Intervention
Cohort 4 - 2 subjects x placebo, QD on Day 1
Group XII: 1 mg Placebo QD x 2 weeksPlacebo Group1 Intervention
Cohort 5 - 2 subjects x 1 mg placebo, QD on Day 1-5, 8-12
Group XIII: 2 mg Placebo QD x 2 weeksPlacebo Group1 Intervention
Cohort 6 - 2 subjects x 2 mg placebo, QD on Day 1-5, 8-12
Group XIV: 3 mg Placebo QD x 2 weeksPlacebo Group1 Intervention
Cohort 7 - 2 subjects x 3 mg placebo, QD on Day 1-5, 8-12
Group XV: 2 mg Placebo QDPlacebo Group1 Intervention
Cohort 2 - 2 subjects x placebo, QD on Day 1
Group XVI: 4 mg Placebo QD x 2 weeksPlacebo Group1 Intervention
Cohort 8 - 2 subjects x 4 mg placebo, QD on Day 1-5, 8-12

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TKL Research, Inc.Industry Sponsor
19 Previous Clinical Trials
1,633 Total Patients Enrolled
Halia Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
161 Total Patients Enrolled
1 Trials studying Normal Healthy Subjects
80 Patients Enrolled for Normal Healthy Subjects
Jesson Yeh, MDPrincipal InvestigatorTKL Research, Inc.
1 Previous Clinical Trials
128 Total Patients Enrolled
~19 spots leftby Nov 2025
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