Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair

This is a multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years
of age, 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
Within 21 days of surgery, eligible subjects will be screened and have routine clinical
laboratory testing and an electrocardiogram performed. Subjects will then undergo an open
inguinal hernia repair under general anesthesia according to the investigator's standard
surgical practice on Day 1. Enrollment in this study will start with the oldest age group (12
to <17 years) and will continue in a step-wise fashion until appropriate doses are
established for all 3 pediatric age groups. Within each age group, the study will be
conducted in 3 parts.

Children in each age group who are randomized to INL-001 will receive approximately 2.5 mg/kg
of INL-001. Study drug will be administered prior to wound closure. The INL-001 matrix will
be cut before placement into the surgical site using sterile technique. Children randomized
to 0.25% Marcaine infiltrate will receive 2.5 mg/kg according to standard practice.

After completion of the surgical procedure, all subjects will remain at the clinic for at
least 3 hours and will be continuously monitored for safety. At the discretion of the
investigator, subjects may receive rescue medication (opioid or non-opioid) upon request for
the management of breakthrough pain and may receive an antiemetic for the management of
nausea or vomiting. After the initial 3 hour period, subjects who are deemed stable can be
discharged to the hospital ward. Subjects will remain housed in the hospital ward for at
least 48 hours. Blood samples will be collected from the subset of 8 children in each age
group after INL-001 is implanted for pharmacokinetic analysis.

Inclusion Criteria:

- Be a male or female 2 to <17 years of age.

- Be eligible for an elective open inguinal hernia repair that will be performed
according to standard surgical technique under general anesthesia.

- Be premenarche or have a serum confirmed negative pregnancy test at screening and a
negative urine pregnancy test before surgery on Day 1, if an adolescent female of
childbearing potential.

- Be willing and able to cooperate with all the requirements of the study.

- Be able to speak and understand English or Spanish.

- Have a legally authorized representative (eg, parent, guardian) who is able to read,
speak, and understand English or Spanish and who will voluntarily sign and date a
parental permission/informed consent form that is approved by the Institutional Review
Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).

- Be willing to sign an assent (if appropriate dependent upon the child's age,
understanding, and IRB requirements), before the conduct of any study procedure.

Exclusion Criteria:

- Has a known hypersensitivity to amide local anesthetics, bovine products, or to
inactive ingredients of the test article.

- Requires any additional surgical procedures, either related or unrelated to the
scheduled surgery (ie, open inguinal hernia surgery), during the same hospitalization.

- Requires epidural or spinal blockade perioperatively.

- Is required to receive neuraxial (spinal or epidural) opioid analgesics during the
study.

- Has undergone major surgery within 3 months of the scheduled surgery or plans to
undergo another surgical procedure within the 30-day post-operative period.

- Has known or suspected history of drug abuse or misuse or evidence of tolerance or
physical dependency on opioid analgesics or sedative-hypnotic medications.

- Has participated in a clinical trial (investigational or marketed product) within 30
days before surgery.

- Has any clinically significant medical history or condition (eg, unstable cardiac,
neurological, immunological, renal, hepatic, or hematological disease or any other
condition) that in the opinion of the investigator, substantially increases the risk
associated with the subject's participation in the protocol or compromises the
scientific objectives of the study.