CompletedNCT05588557Updated Nov 27, 2024

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

A Phase 1 interventional study of Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection and ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension in Pain, Postoperative, sponsored by Nang Kuang Pharmaceutical Co., Ltd.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Nang Kuang Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 20 Years to 45 Years
Sex: All

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.

Read the 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 studied

Pain, Postoperative

Browse trials for

Pain, Postoperative 5,093

Keywords

Bupivacaine
Pharmacokinetics
Analgesics

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 24 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Nang Kuang Pharmaceutical Co., Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

20 - 45 year-old healthy male subjects or female subjects who are in non-lactating and non-pregnant status.
Subjects must have a Body Mass Index (BMI) of 18.5 to 30.0 Kg/m², inclusive. For male subjects, body weight must be above 50 kg; for female subjects, body weight must be above 45 kg. BMI = Weight (kg)/Height (m2).
Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit.
Able and willing to comply with all study visits and procedures.
The informed consent form has been read, signed and dated by the subject.
Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting subject-reported outcomes.

Exclusion criteria

Exclusion Criteria:

Subject has a sitting pulse rate outside the reference range of 50 to 90 beats per minute or an ear temperature outside the reference range of 35.0 to 37.5°C or a sitting blood pressure less than 90/50 mmHg or more than 140/90 mmHg at screening visit.
Subject has clinically significant results of physical examination, laboratory tests, electrocardiogram, or chest X-ray as judged by the investigator at the screening visit.
With abnormal results of sensory and neurological assessment as judged by the investigator at the screening visit.
Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkalinephosphatase (ALP), or total bilirubin, if any one of them is out of the reference range.
Presence of impaired renal function as indicated by abnormal creatinine or blood urea nitrogen values or abnormal urinary constituents, if any one of them is out of the reference range.
Known of active infection with HIV, HBV, or HCV as defined by blood tests at the screening visit.
Presence of clinically significant illness, such as cardiovascular disease, cerebrovascular disease, metabolic disease, respiratory disease, neurological disease, psychiatric disease, cancers or immunological disease, may increase the risk of study as judged by the investigator at the screening visit.
Subject does not agree not to take any prescription, over-the-counter medication, herbal medicine and dietary supplement (including multivitamins) within two weeks before hospital admission and until the end of the study.
Subject does not agree not to consume any beverage or food that might affect the drug metabolism, such as pomelo, grapefruit or related products within one week before hospital admission and until the end of the study.
Subject does not agree not to consume any caffeine-containing product (e.g., tea, coffee, coke, or chocolate) 3 days prior to hospital admission and until the end of the study.
Subject does not agree not to consume any product containing tobacco, nicotine (such as e-cigarettes, nicotine gum), and alcohol 3 days prior to hospital admission and until the end of the study.
Administration of an investigational drug within 2 months or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration; or planned administration of another investigational product or procedure during the study period.
Donation or loss of more than 500 mL and 250 mL of blood within 3 months and 2 months before the screening visit, respectively.
Known with a history of allergy or hypersensitivity to medicine as judged by the investigator at the screening visit.
Female subject who is breast-feeding, pregnant, or planning to become pregnant.
Subject does not agree to use effective non-hormonal contraception method to prevent from pregnancy ('double barrier method': condoms used concomitantly with vaginal sponge, diaphragm or intra-uterine contraceptive device) or abstain from sexual behavior with his/her partner from screening until the end of the study.
Individual is not eligible to be a subject for other reasons based on the judgment of investigator.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 24 participants (actual)

Study arms

Active comparator
Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection
Marcaine® at 150 mg in each cohort.
Drug: Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection
Experimental
ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension
ND-340(90-320 mg) at dose escalations
Drug: ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension

Interventions

DrugMarcaine® 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).
DrugND-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).

What researchers measure

Primary outcomes

Adverse events as assessed by CTCAE v 5.0
Treatment-related adverse events will be analyzed by cohort
Time frame: From administration of ND-340 to 140 hours
Changes in 12-lead ECG and Holter monitor
To definition safety profile in cardiac events, vent. rate, PR interval, QRS duration, QT interval, QTc interval
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hour
Changes in Laboratory test - hematology
Hemoglobin, Hct, RBC count, WBC count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelet count
Time frame: Pre-dose, 140 hour
Changes in Laboratory tests - biochemistry
Albumin, Total protein, ALT, AST, ALP, Total bilirubin, BUN, Serum creatinine, K, Na, Mg, Ca, P, Uric acid, Total cholesterol, HbA1c
Time frame: Pre-dose, 140 hour
Changes in Laboratory tests - urinalysis
pH, Specific gravity, Leukocyte, Erythrocyte, Protein, Glucose
Time frame: Pre-dose, 140 hour
Changes in vital signs
To definition safety profile including body temperature,blood pressure, respiratory rate, pulse rate
Time frame: Screening visit, day 0 (Pre-dose, 60 mins), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Changes in physical examination
To definition safety profile including general appearance, HEENT, neck, Lymph nodes, skin, cardiovascular, pulmonary, abdomen, neurological system, musculoskeletal/joints
Time frame: Screening visit, day -1, Day 6
The tolerability and maximal tolerated dose (MTD) of ND-340 by dose-limiting toxicities (DLTs)
The incidence of DLT will be summarized by each cohort. The number of subject who has DLT will be summarized by cohorts. and the determination of MTD in this study will be provided.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hour
Cmax
Maximum Plasma Concentration of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Tmax
Time of peak concentration of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
AUC 0-t
Area under the plasma concentration versus time curve from zero to t of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
AUC 0-∞
Area under the plasma concentration versus time curve from zero to infinity of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
T1/2
Terminal half life of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
CL/F
Clearance/Bioavailability of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
λz
Terminal elimination rate constant
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
Vz/F
Apparent volume of distribution during terminal phase after non-intravenous administration
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
MRT 0-∞
Mean residence time from zero to infinity of ND-340
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours

Secondary outcomes

Range of motion of knee
The range of motion (ROM) of knee as measured by knee flexion and extension at baseline and subsequent visits, and the change from baseline will be summarized descriptively by cohorts and drugs(ND-340 or Marcaine®).
Time frame: Pre-dose, 1, 2, 4, 8, 18, 24, 32, 44, 56, 68, 80, 92,104,116,128,140 hours
The ambulation distance
The ambulation distance as measured by six-minute walk test (6MWT) at baseline and subsequent visits, and the change from baseline will be summarized descriptively by cohorts and drugs (ND-340 or Marcaine®).
Time frame: Once a day on Pre-dose, Day 1 and Day 2

Study locations

1 site

National Taiwan University Hospital
Taipei city, 100229, Taiwan

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05588557
Lead sponsor: Nang Kuang Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Oct 20, 2022
Start date: Jul 8, 2022
Primary completion: Mar 19, 2024
Completion: Mar 19, 2024
Last update: Nov 27, 2024

Study contacts

Chih-Peng Lin, MD, PhD

principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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