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HT-6184

Phase 1

Normal Healthy Subjects | Small molecule | Other |IQVIA Holdings, Inc.|Last Updated: Aug 28, 2023

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

HT-6184 · 1 trial · 1 indication

Phase 1 1
NCT05447546Study to Evaluate HT-6184 in Healthy SubjectsNormal Healthy Subjects
COMPLETED64 Analytics
PHASE1COMPLETED
Study to Evaluate HT-6184 in Healthy Subjects
Normal Healthy Subjects
NCT0544754664
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Study Endpoints

Primary Endpoints

Incidence of adverse events administered as single oral doses at escalating dose levels in healthy volunteer subjects.
up to 6 weeks

Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related adverse events.

Incidence of abnormal laboratory test results
up to 6 weeks

Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal lab values.

Incidence of treatment-emergent clinically abnormal electrocardiogram (ECG)
up to 6 weeks

Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal ECG.

Incidence of treatment-emergent clinically abnormal physical exam
up to 6 weeks

Safety and tolerability of HT-6184 as measured by subject incidence of treatment-related abnormal physical exam.

Secondary Endpoints

Plasma maximum measured drug concentration (Cmax)
up to 6 weeks
Time of maximum concentration (Tmax)
up to 6 weeks
Area under the plasma concentration-time curve (AUC0-24)
up to 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1 mg HT-6184 QDACTIVE_COMPARATORCohort 1 - 6 subjects x 1 mg HT-6184 QD on Day 1
1 mg Placebo QDPLACEBO_COMPARATORCohort 1 - 2 subjects x placebo, QD on Day 1
2 mg HT-6184 QDACTIVE_COMPARATORCohort 2 - 6 subjects x 2 mg HT-6184 QD on Day 1
2 mg Placebo QDPLACEBO_COMPARATORCohort 2 - 2 subjects x placebo, QD on Day 1
3 mg HT-6184 QDACTIVE_COMPARATORCohort 3 - 6 subjects x 3 mg HT-6184 QD on Day 1
3 mg Placebo QDPLACEBO_COMPARATORCohort 3 - 2 subjects x placebo, QD on Day 1
4 mg HT-6184 QDACTIVE_COMPARATORCohort 4 - 6 subjects x 4 mg HT-6184 QD on Day 1
4 mg Placebo QDPLACEBO_COMPARATORCohort 4 - 2 subjects x placebo, QD on Day 1
1 mg HT-6184 QD x 2 weeksACTIVE_COMPARATORCohort 5 - 6 subjects x 1 mg HT-6184 QD on Day 1-5, 8-12
1 mg Placebo QD x 2 weeksPLACEBO_COMPARATORCohort 5 - 2 subjects x 1 mg placebo, QD on Day 1-5, 8-12
2 mg HT-6184 QD x 2 weeksACTIVE_COMPARATORCohort 6 - 6 subjects x 2 mg HT-6184 QD on Day 1-5, 8-12
2 mg Placebo QD x 2 weeksPLACEBO_COMPARATORCohort 6 - 2 subjects x 2 mg placebo, QD on Day 1-5, 8-12
3 mg HT-6184 QD x 2 weeksACTIVE_COMPARATORCohort 7 - 6 subjects x 3 mg HT-6184 QD on Day 1-5, 8-12
3 mg Placebo QD x 2 weeksPLACEBO_COMPARATORCohort 7 - 2 subjects x 3 mg placebo, QD on Day 1-5, 8-12
4 mg HT-6184 QD x 2 weeksACTIVE_COMPARATORCohort 8 - 6 subjects x 4 mg HT-6184 QD on Day 1-5, 8-12
4 mg Placebo QD x 2 weeksPLACEBO_COMPARATORCohort 8 - 2 subjects x 4 mg placebo, QD on Day 1-5, 8-12

Interventions

NameTypeDescription
HT-6184DRUGOral capsule
HT-6184 PlaceboDRUGOral capsule
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Is male or female, between 18 and 65 years of age (inclusive) at Screening; 2. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at Screening 3. Is in good general health, as determined by the Investigator, without clinically significant medical history; 4. ...

Countries:United States
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