MedTrace Logo

Study to Evaluate HT-6184 in Healthy Subjects

NCT05447546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-08-28

No results posted yet for this study

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.

Conditions

  • Normal Healthy Subjects

Interventions

DRUG

HT-6184

Oral capsule

DRUG

HT-6184 Placebo

Oral capsule

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Halia Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jesson Yeh, MD · TKL Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2023-07-20
Completion
2023-07-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05447546 on ClinicalTrials.gov