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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 8, 2022

Primary Completion Date

March 19, 2024

Study Completion Date

March 19, 2024

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)."

Trial Locations (1)

100229

National Taiwan University Hospital, Taipei

All Listed Sponsors
lead

Nang Kuang Pharmaceutical Co., Ltd.

INDUSTRY