AMT-143 Hydrogel for Pain After Hernia Surgery

Recruiting in Palo Alto (17 mi)

Overseen byJames Paul, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AmacaThera Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of three ascending doses of AMT-143 to determine the appropriate dose of AMT-143 for the management of postsurgical pain following inguinal hernia repair. Healthy male and female participants ≥18 years of age scheduled for open inguinal hernia repair surgery will be enrolled. Participants will all receive general anesthesia. The open inguinal hernia repair will be performed by a participating surgeon and the study medication will be administered by the surgeon prior to wound closure. AMT-143 is provided as a hydrogel containing 385 mg/mL ropivacaine (on a ropivacaine HCl equivalence basis). AMT-143 hydrogel will be provided as pre-filled syringes for administration via instillation into the surgical site after surgery and prior to suture. This will be a randomized, single blind, placebo and active controlled, dose escalation study performed at one clinical site to determine optimal doses of AMT-143. The study will consist of 30 participants, 10 per dose. Participants will receive AMT-143, or saline placebo, or ropivacaine 1% solution. Participants will be blinded to treatment. All assessments up to 4 h will be performed in the hospital clinic setting. Post discharge follow-up for the study will be handled on an outpatient basis and will be conducted by a home nurse up to Day 21. The participant will return to the clinical site for a final End of Study visit on Day 28.

Eligibility Criteria

This trial is for healthy adults over 18 who are scheduled for open inguinal hernia repair surgery. They must be able to receive general anesthesia and agree to post-surgery follow-up. People with conditions that might interfere with the study or pose a risk if they participate are not eligible.

Inclusion Criteria

Body mass index (BMI) ≤40.0 kg/m2

Provides voluntary written informed consent

I am 18 years old or older.

+4 more

Exclusion Criteria

History of hypersensitivity or allergy to amide type local anaesthetics (lidocaine, bupivacaine, or ropivacaine)

Have a clinically significant abnormal clinical laboratory test value, according to the judgement of the investigator

Have a clinically significant 12-lead ECG abnormality, according to the judgement of the investigator

+6 more

Participant Groups

The trial is testing three doses of AMT-143, a hydrogel containing ropivacaine, against a placebo and regular ropivacaine solution for pain management after hernia surgery. It's randomized and single-blind, meaning participants won't know which treatment they get.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: active AMT-143 hydrogelExperimental Treatment1 Intervention

6 participants in the first cohort will receive 1 mL AMT-143 hydrogel containing 385 mg ropivacaine. 6 participants in the second cohort will receive 2 mL AMT-143 hydrogel containing 770 mg ropivacaine. 6 participants in the third cohort will receive 3 mL AMT-143 hydrogel containing 1,155 mg ropivacaine

Group II: Ropivacaine solutionActive Control1 Intervention

2 participants in the first cohort will receive 5 mL Ropivacaine 10 mg 1% solution. 2 participants in the second cohort will receive 5 mL Ropivacaine 10 mg 1% solution. 2 participants in the third cohort will receive 5 mL Ropivacaine 10 mg 1% solution.

Group III: PlaceboPlacebo Group1 Intervention

2 participants in the first cohort will receive 1 mL saline placebo. 2 participants in the second cohort will receive 1 mL saline placebo. 2 participants in the third cohort will receive 1 mL saline placebo.