1 mg HT-6184 QD for Normal Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
TKL Research, Inc., Fair Lawn, NJ
Normal Healthy Subjects
HT-6184 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is safe and works as intended. They will give it to healthy volunteers at different doses to see what happens. 1mg of HT-6184 is given once a day to normal, healthy subjects as a free treatment.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Normal Healthy Subjects

Study Objectives

4 Primary · 9 Secondary · Reporting Duration: 24 hours

24 hours
Apparent clearance (CL/F)
Apparent volume of distribution at steady state (Vss/F)
Area under the plasma concentration-time curve (AUC0-24)
Area under the plasma concentration-time curve (AUC0-inf)
Area under the plasma concentration-time curve (AUC0-last)
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)
Incidence of treatment-emergent clinically abnormal physical exam
Plasma half-life (T½)
Plasma maximum measured drug concentration (Cmax)
Terminal elimination rate constant (kel)
Time of maximum concentration (Tmax)

Trial Safety

Safety Progress

1 of 3

Other trials for Normal Healthy Subjects

Trial Design

8 Treatment Groups

1 mg HT-6184 QD
1 of 8
2 mg HT-6184 QD
1 of 8
3 mg HT-6184 QD
1 of 8
4 mg HT-6184 QD
1 of 8
4 mg Placebo QD
1 of 8
1 mg Placebo QD
1 of 8
2 mg Placebo QD
1 of 8
3 mg Placebo QD
1 of 8
Active Control
Non-Treatment Group

32 Total Participants · 8 Treatment Groups

Primary Treatment: 1 mg HT-6184 QD · Has Placebo Group · Phase 1

4 mg Placebo QD
Drug
PlaceboComparator Group · 1 Intervention: HT-6184 Placebo · Intervention Types: Drug
1 mg HT-6184 QD
Drug
ActiveComparator Group · 1 Intervention: HT-6184 · Intervention Types: Drug
1 mg Placebo QD
Drug
PlaceboComparator Group · 1 Intervention: HT-6184 Placebo · Intervention Types: Drug
2 mg HT-6184 QD
Drug
ActiveComparator Group · 1 Intervention: HT-6184 · Intervention Types: Drug
2 mg Placebo QD
Drug
PlaceboComparator Group · 1 Intervention: HT-6184 Placebo · Intervention Types: Drug
3 mg HT-6184 QD
Drug
ActiveComparator Group · 1 Intervention: HT-6184 · Intervention Types: Drug
3 mg Placebo QD
Drug
PlaceboComparator Group · 1 Intervention: HT-6184 Placebo · Intervention Types: Drug
4 mg HT-6184 QD
Drug
ActiveComparator Group · 1 Intervention: HT-6184 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours
Closest Location: TKL Research, Inc. · Fair Lawn, NJ
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2008First Recorded Clinical Trial
1 TrialsResearching Normal Healthy Subjects
14 CompletedClinical Trials

Who is running the clinical trial?

TKL Research, Inc.Industry Sponsor
18 Previous Clinical Trials
1,600 Total Patients Enrolled
Halia Therapeutics, Inc.Lead Sponsor
Jesson Yeh, MDPrincipal InvestigatorTKL Research, Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are using combined oral, intravaginal, or transdermal hormonal contraception associated with inhibition of ovulation.
You have normal laboratory values as defined by the clinical laboratory reference range.
You have normal physical examination, 12-lead ECG, and vital signs, as determined by the Investigator.
You are male or female, between 18 and 65 years of age (inclusive) at Screening.
You have a body mass index (BMI) between 18.0 and 32.
You are in good general health.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.