Phase II Pharmacokinetics Study of CAM2038

This is a phase II, open label, randomized, two treatment group study designed to evaluate
the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated
subcutaneous administrations of CAM2038 weekly at different injection sites and to evaluate
the steady state pharmacokinetics of buprenorphine and norbuprenorphine after repeated
subcutaneous administration of CAM2038 monthly in opioid dependent subjects with a history
of chronic non cancer pain. The study will involve three phases: Screening, Treatment, and
Follow up.

Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any study
related procedures.

2. Male or non pregnant, non lactating female subject, aged 19 to 65 years, inclusive.

3. Body mass index between 19 and 35 kg/m2, inclusive.

4. Current diagnosis of moderate to severe opioid use disorder (according to the DSM 5)
or past medical history of opioid use disorder currently being treated with SL BPN.

5. Subject must be taking SL BPN (Subutex® equivalent) 24 mg daily for at least 30 days
prior to Screening.

6. Subject has a history of moderate to severe chronic non cancer pain.

Exclusion Criteria:

1. Individuals meeting DSM 5 substance use disorder criteria for alcohol,
benzodiazepines, central nervous system (CNS) stimulants, or other drugs of abuse
(excluding caffeine, tobacco or THC/marijuana).

2. Any clinically significant abnormality on the basis of medical history, vital signs,
physical examination, 12 lead electrocardiogram and laboratory evaluations

3. Use (therapeutic or non therapeutic) of opioids other than SL BPN.

4. Aspartate aminotransferase (AST) levels > 3 X the upper limit of normal, alanine
aminotransferase (ALT), levels > 3 X the upper limit of normal, total bilirubin > 1.5
X the upper limit of normal, or creatinine > 1.5 X upper limit of normal.

5. Pregnant or lactating or planning to become pregnant during the study.

6. Diagnosis of, or currently under investigation for, fibromyalgia, complex regional
pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord
compression, acute nerve root compression, severe or progressive lower extremity
weakness or numbness.

7. History of chemotherapy or confirmed malignancy (except basal cell or squamous
carcinoma of the skin) within the past 2 years.

8. Clinically significant history of, or current evidence for, suicidal ideation or
those who are actively suicidal, as based on the Columbia Suicide Severity Rating
Scale (C SSRS; grade 4 or 5).

9. Clinically significant history of major depressive disorder that is poorly controlled
with medication.

10. Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038.

11. Exposure to any investigational drug within the 4 weeks prior to Screening.

12. Participants with a clinically significant history of risk factors of Torsades de
Pointes and any existing ventricular tachyarrhythmias such as bigeminy, trigeminy,
heart failure, hypokalemia, family history of Long QT Syndrome.

13. Requires current use of agents that have the potential for prolonging the QTc
interval.

14. Requires current use of agents that are strong inhibitors or inducers of cytochrome
P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide
antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir,
indinavir, and saquinavir).