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Pharmacokinetic and Safety Study of HYR-PB21 vs Bupivacaine Hydrochloric Acid in Healthy Participants

NCT07717086 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-07-21

No results posted yet for this study

Summary

This is a Phase I, randomized, single-blind, active-controlled, single-dose, parallel-group study to evaluate the safety and pharmacokinetic (PK) profile of HYR-PB21, a pamoate-formulated bupivacaine injectable, in healthy adult participants.

Participants are randomized to receive a single subcutaneous dose of HYR-PB21 at one of three dose levels (100 mg, 200 mg, or 400 mg) or a single 100 mg dose of Bupivacaine hydrochloride injection (as base) as active control.

The primary objectives are to characterize the PK profile of HYR-PB21 at the three dose levels compared with Bupivacaine hydrochloride, and to determine the Pharmacokinetics characteristics of the pamoic acid moiety following HYR-PB21 administration. Secondary objectives are to extend cumulative safety and tolerability observations of single subcutaneous doses of HYR-PB21 in healthy adults.

Conditions

  • Postoperative Analgesia

Interventions

DRUG

HYR-PB21， 100 mg

HYR-PB21， 100 mg, administered as a single subcutaneous injection.

DRUG

HYR-PB21， 200 mg

HYR-PB21 200 mg, administered as a single subcutaneous injection.

DRUG

HYR-PB21， 400 mg

HYR-PB21 400 mg, administered as a single subcutaneous injection.

DRUG

Bupivacaine hydrochloride， 100 mg (as base)

Bupivacaine Hydrochloric acid injection 100 mg (expressed as bupivacaine base), administered as a single subcutaneous injection. Active comparator.

Sponsors & Collaborators

  • Frontage Clinical Services

    collaborator UNKNOWN

  • Fruithy Holdings Limited

    lead INDUSTRY

Principal Investigators

  • shanchun zhang, Doctor · Fruithy Holdings Limited

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2026-09-30
Completion
2026-10-31
FDA Drug
Yes

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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 NCT07717086 on ClinicalTrials.gov