drugset
drugset / Trial / NCT05447546

Study to Evaluate HT-6184 in Healthy Subjects

NCT05447546 ↗

Phase 1 Completed 64 enrolled Halia Therapeutics, Inc. TKL Research, Inc. · collab
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2022-06-15
Primary completion
2023-07-20
Completion
2023-07-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ofirnoflast Small molecule 1 mg Oral
Comparator Ofirnoflast Small molecule 2 mg Oral
Comparator Ofirnoflast Small molecule 3 mg Oral
Comparator Ofirnoflast Small molecule 4 mg Oral

Indications

No indication recorded.