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

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults

In brief

The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55. The main questions it aims to answer are: * Is a single injection of JST-010 safe? * What is the concentration of the JST-01 in the blood over time? * Do antibodies to JST-010 develop following a dose of JST-010? Researchers will compare JST-010 to Placebo to see if there are any differences in the safety and tolerability of a single dose at different dose levels. Participants will be confined to the clinic for the first 3 days. They will receive an injection on the second day, and then return for 9 more visits over the period of 1 year for: * Physical exam with vital signs * Electro-cardiogram (ECG) * Bood collection for clinical labs and research samples * Urine sample * Assessment of potential adverse effects and medications taken

Key facts

Study ID

NCT06943378

Run by

Just-Evotec Biologics

People needed

104

Starts

2025-05-16

Expected to finish

2027-10-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men or women 18 to 55 years of age
• BMI between 18 and 32 kg/m2
• Negative serum pregnancy test
• Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence
• In good general health as determined by medical history, exams and tests

You may not qualify if…

• 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

Where it is running

• PPD Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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