Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain

NCT04182880 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CPL-01_AB_001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty

Conditions

Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Mean (Peak) Plasma Concentration (Cmax)

  Mean Cmax of 573 ng/mL and occurred at approximately 13 hours. Timepoints tested included before study drug administration and 15, 30, and 45 minutes and 1, 2, 4, 6, 8, 10, 12, 18, 24, 30, 36, 48, 60, 72, 96, and 120 hours after administration.

  Baseline through 120 hours after start of study drug administration

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

CPL-01

EXPERIMENTAL

CPL-01

Drug: CPL-01

Interventions

CPL-01 DRUG

CPL-01 will be administered

CPL-01

Placebo DRUG

Placebo will be administered

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides signed, written informed consent before participation in the study.
• Subject is aged ≥18 and ≤70 years at the time of informed consent and is male or female.
• Subject is scheduled to undergo elective mini-abdominoplasty surgery under general anesthesia without collateral procedures.
• Female subjects are eligible only if all the following apply:
• Not pregnant
• Not breastfeeding
• Not planning to become pregnant during participation in the study
• Committed to the use of an acceptable form of birth control for the duration of the study until at least 30 days after administration of IP.
• Male subjects must commit to the use of a reliable method of birth control for the duration of the study until at least 30 days after administration of IP or be surgically sterile (biologically or surgically).
• Subject is free of any physical, mental, or medical conditions which, in the opinion of the investigator, make mini-abdominoplasty or study participation inadvisable.

You may not qualify if:

• Subject has known, suspected, or reported history of alcohol or drug abuse or dependence within the previous 2 years as assessed by the investigator
• Subject has impaired liver function (e.g., aspartate aminotransferase/alanine aminotransferase greater than 3 times the upper limit of the reference range, bilirubin greater than 1.5 times the upper limit of the reference range unless due to Gilbert's syndrome, active hepatic disease, evidence of clinically significant liver disease, or other condition such as alcoholism, cirrhosis, or hepatitis, etc.) that suggests the potential for an increased susceptibility to hepatic toxicity with IP exposure.
• Subject has clinically significant renal abnormalities (creatinine ≥1.5 × upper limit of normal).
• Subject has hemoglobin A1c ≥7.0%.
• Subject has participated in another clinical study and/or received an IP (marketed or premarket) within 30 days before surgery.
• Subject has a history of, or positive test results for, human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody at Screening.
• Subject with an upper respiratory infection/cough in the 14 days before surgery.
• Subjects with a history of significant postoperative nausea and vomiting.

Sponsors & Collaborators

• Cali Pharmaceuticals LLC: lead

Study Sites (1)

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

Related Publications (1)

• Pope S, Crean C, Thrasher S, Xu H, Chen PJ, Chen L, Hu D, Onel E. Comparison of Pharmacokinetics of Long-Acting Local Analgesics: CPL-01, a Novel Extended-Release Ropivacaine, Demonstrates Consistent and Predictable Exposure Compared with Liposomal Bupivacaine. Clin Drug Investig. 2025 Feb;45(2):51-58. doi: 10.1007/s40261-025-01419-w. Epub 2025 Jan 29.

  PMID: 39881115 RESULT

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Cali Biosciences

e.onel@calibiosciences.com

12038376500

Study Officials

• Erol Onel, MD

  Cali Biosciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: January 6, 2020
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: April 13, 2026
• Results First Posted: September 21, 2022

Record last verified: 2026-04

Locations

US (1)