NCT05588557

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

A Phase I Dose-escalation Study, Randomized Comparison with Active Control to Evaluate the Safety and Pharmacokinetics of a Single Administration of ND-340 Via Adductor Canal Block (ACB) and IPACK Block in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Nang Kuang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The current investigational product, ND-340, is a bupivacaine microsphere injection with an extended release profiling. Lipid microsphere, or liposphere, has been proposed as new type of lipid-based encapsulation system for drug delivery of bioactive compounds especially lipophilic compound. ND-340 has not been studied in human before. However, MARCAINE® and EXPAREL® are both FDA-approved drugs, which contain the same active pharmaceutical ingredient (API) as ND-340, which is bupivacaine. MARCAINE® is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. In this study, Investigators will focus on determining the safety, tolerability, and pharmacokinetic profile of ND-340.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-07-08
• Primary completion: 2024-03-19
• Completion: 2024-03-19
• First posted: 2022-10-20
• Last updated: 2024-11-27

Locations

1 site across 1 country: Taiwan