Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 2:40 PM
Study NCT ID:
NCT05588557
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Evaluate the Safety and PK of ND-340 in Healthy Volunteers
Sponsor:
Nang Kuang Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: