A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful diabetic neuropathy.
Key Inclusion Criteria:
* Is in good general health as determined by Investigator's review.
* Has a body mass index (BMI) between 18 and 35 kg/m2.
* Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
* For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.
* For males, must agree to use barrier contraception and not to donate sperm
Key Exclusion Criteria:
* Is pregnant, lactating, or planning a pregnancy during the study.
* Tests positive for COVID-19 after screening is complete and subject is confirmed to enroll
* History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
* Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.
* Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse
* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
Key Inclusion Criteria- PDN Cohort
* A diagnosis/history of Type 2 diabetes mellitus
* The pain is present in both feet/legs with symmetrical onset
* The pain is characterized as burning, painful, cold or electrical shocks in nature
* The pain is associated with tingling, numbness, itching or pins and needles type sensations
* The pain has been present and consistent for ≥ 6 months
Key Exclusion Criteria- PDN Cohort
* Diagnosis of Type 1 diabetes
* Has serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness
* Has a history or currently active type of cancer except excised or cured basal cell carcinoma.
* Has a History of psychological conditions or neurological disorders
* Has a History of lower back pain with radiculopathy
* Has received non-pharmacological treatment for pain within 14 days
* Has a history of frequent and/or severe allergic reactions with multiple medications
Locations (1)
AltaSciences
Overland Park, Kansas, United States
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability) with CNTX-6016
Number of participants with TEAEs, which includes laboratory test variables