Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

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…