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NOT YET RECRUITING
NCT07799597
PHASE1

Comparison of HBW-3220 Capsule Formulations and the Effect of Food in Healthy Participants

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This Phase 1 study will evaluate a new formulation of HBW-3220 capsules in healthy adults. It will compare how much and how quickly HBW-3220 enters the bloodstream after a single 120 mg dose of the new formulation versus the previous formulation under fasting conditions, and after the new formulation is taken under fed versus fasting conditions. Twenty-one participants will be randomly assigned to one of three treatment sequences and will receive all three treatments during three study periods, with at least 7 days between doses. Blood samples will be collected for pharmacokinetic analysis, and safety and tolerability will be assessed throughout the study and during follow-up.

Official title: A Randomized, Open-Label, Crossover Phase 1 Clinical Trial to Evaluate the Relative Bioavailability and Food Effect of a New Formulation of HBW-3220 Capsules in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2026-09-05

Completion Date

2028-12-31

Last Updated

2026-09-02

Healthy Volunteers

Yes

Interventions

DRUG

HBW-3220 Old Formulation Under Fasting Conditions

A single oral dose of 120 mg HBW-3220 old formulation, administered as four 30 mg capsules under fasting conditions.

DRUG

HBW-3220 New Formulation Under Fasting Conditions

A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules under fasting conditions.

DRUG

HBW-3220 New Formulation Under Fed Conditions

A single oral dose of 120 mg HBW-3220 new formulation, administered as four 30 mg capsules after a high-fat, high-calorie meal.