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A Phase I Study to Evaluate the Safety and PK of ND-340 in Healthy Volunteers

NCT05588557 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-27

No results posted yet for this study

Summary

This study focuses on ND-340 extended release injection suspension for healthy volunteers with a one-time nerve blockade to determine the safety, tolerability, and pharmacokinetic profile.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection

Subjects in this arm will receive a single administration of Marcaine® at the 150 mg. Marcaine® will be administered under ultrasound guidance with a total volume of 40 mL, of which 20 mL will be used via adductor canal block (ACB) and the other 20 mL will be used as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee).

DRUG

ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension

Subjects in this arm will receive a single administration of ND-340 at the specified dose (90-320 mg). ND-340 will be administered under ultrasound guidance with a total volume of 40 mL, of which 20 mL will be used via adductor canal block (ACB) and the other 20 mL will be used as IPACK block (interspace between the popliteal artery and the capsule of the posterior knee).

Sponsors & Collaborators

  • Nang Kuang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chih-Peng Lin, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2024-03-19
Completion
2024-03-19

Countries

  • Taiwan

Study Locations

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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 NCT05588557 on ClinicalTrials.gov