Status:
RECRUITING
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
Lead Sponsor:
Just-Evotec Biologics
Conditions:
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This is a two-part, Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) (Part 1) and dose expansion (Part 2) study to assess the safety, tolerabili...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06943378
Start Date
May 16 2025
End Date
October 1 2027
Last Update
June 8 2025
Active Locations (1)
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1
PPD Las Vegas Clinical Research Unit
Las Vegas, Nevada, United States, 89113