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

Launched by CENTREXION THERAPEUTICS · Apr 22, 2021

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Eligibility criteria

• 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