Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults

Exclusion Criteria29

• Acute illness or fever (≥100.4°F) within 7 days prior to dosing
• Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against the Yersinia pestis bacterium
• Receipt of any vaccine within 30 days prior to Screening, planned receipt of any vaccine prior to Day 1, or planned receipt of any vaccines before 45 days post-injection.
• Any medical condition for which IM injections would be contraindicated in the opinion of the investigator (eg, bleeding disorders, anticoagulant therapy, and severe thrombocytopenia)
• History of congenital or acquired immunodeficiency syndrome
• Prior solid organ or bone marrow transplant
• Use of systemic steroids, immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior. A single short course (ie, less than 14 days) is allowed provided it is concluded more than 6 months prior to Screening
• Upper arm is with insufficient muscular tissue for IM injections or is obscured by tattoos or rash that may preclude accurate assessment of injection site reactions
• Use of any medications started within 30 days prior to Day -1, including prescription medications, nutritional supplements, and over-the-counter medications
• Vitamin supplements are allowed
• Recommended doses of acetaminophen are allowed, except for 24 hours prior to dosing
• Recommended doses of non-steroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen) are also allowed, except for 7 days prior to dosing
• Positive human immunodeficiency virus (HIV-1/-2) antibody result by history or at Screening
• Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody
• Positive urine drug test or cotinine (indicating active current smoking) at Screening or Day -1, positive alcohol breath test at Screening or on Day -1, or suspected/known drug abuse and/or alcohol use disorder
• Smoking or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months before study drug dosing
• Dosing in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of receiving the investigational drug prior to Screening
• Progressive, unstable, or uncontrolled medical conditions that have required medical attention or changes to medication for medical reasons within 90 days prior to consent
• History of allergic reactions or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins
• Receipt of any mAbs in the 12 months prior to Screening
• High blood pressure
• History of hyperprolinemia
• Women who are either pregnant or breast-feeding
• Vulnerable individuals (eg, military recruits, persons in compulsory detention, those with limited legal capacity)
• Receipt of immunoglobulins or any blood products within 90 days prior to consent or planned receipt during the study period
• Donation or loss of \>500 mL of blood within 30 days or plasma within 7 days of Day 1; any planned donation of blood or plasma during the study period
• History of any malignant neoplasm within the last 5 years, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin or the cervix
• Strenuous activity or contact sports within 48 hours before study drug dosing and through Day 8
• History of relevant drug and/or food allergies