A Phase I Study to Evaluate the Safety and PK of ND-340 in Healthy Volunteers
NCT ID: NCT05588557
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2022-07-08
2024-03-19
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Marcaine® 100mg/20mL (0.5%) bupivacaine solution for Injection
Marcaine® at 150 mg in each cohort.
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).
ND-340 (Bupivacaine Microsphere), 300 mg/vial bupivacaine for extended-release injectable suspension
ND-340(90-320 mg) at dose escalations
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit.
4. Able and willing to comply with all study visits and procedures.
5. The informed consent form has been read, signed and dated by the subject.
6. Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting subject-reported outcomes.
Exclusion Criteria
2. Subject has clinically significant results of physical examination, laboratory tests, electrocardiogram, or chest X-ray as judged by the investigator at the screening visit.
3. With abnormal results of sensory and neurological assessment as judged by the investigator at the screening visit.
4. 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.
5. 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.
6. Known of active infection with HIV, HBV, or HCV as defined by blood tests at the screening visit.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Donation or loss of more than 500 mL and 250 mL of blood within 3 months and 2 months before the screening visit, respectively.
14. Known with a history of allergy or hypersensitivity to medicine as judged by the investigator at the screening visit.
15. Female subject who is breast-feeding, pregnant, or planning to become pregnant.
16. 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.
17. Individual is not eligible to be a subject for other reasons based on the judgment of investigator.
20 Years
45 Years
ALL
Yes
Sponsors
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Nang Kuang Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chih-Peng Lin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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NKC340-202101
Identifier Type: -
Identifier Source: org_study_id