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

NCT07799597 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-09-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

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.

Sponsors & Collaborators

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-09-05
Primary Completion
2028-07-31
Completion
2028-12-31

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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 NCT07799597 on ClinicalTrials.gov