Back to search results

JST-010 for Pneumonic Plague Prevention in Healthy Adults

This study is testing a single dose of JST-010, a monoclonal antibody (a type of protein that helps your body fight disease), to see if it's safe and well-tolerated in healthy adults aged 18 to 55. JST-010 is being developed to help prevent pneumonic plague. Researchers want to understand how much JST-010 stays in your blood over time and if your body develops antibodies to it. You would receive either JST-010 or a placebo (an inactive substance like a sugar pill) by injection. The study is currently unclear on its recruitment status and plans to enroll 104 participants.

Study design
This is a Phase 1, randomized, double-blind, placebo-controlled study with single ascending doses. It will involve approximately 104 healthy adult participants.
What's involved
You would be confined to the clinic for the first 3 days. The study involves medical history, exams, and tests.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the injection until your final visit at Week 48.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06943378

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

Active, Not Recruiting
PHASE1Ages 18–55InterventionalPrevention
Just-Evotec Biologics
~104 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Monoclonal antibody JST-010Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults
Measured over 1) Local and systemic solicited AES from injection to Day 7, 2) All AEs post-injection to final visit at Week 48, 3) SAEs, MAAEs, and AESIs post-injection to final visit at Week 48

Conditions

Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults

Explore related trials

Healthy VolunteersPneumonic plague

NCT06943378

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • PPD Las Vegas Clinical Research Unit

    Las Vegas, Nevadano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

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 10. Positive human immunodeficiency virus (HIV-1/-2) antibody result by history or at Screening 11. Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody 12. 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 13. 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 14. 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 15. Progressive, unstable, or uncontrolled medical conditions that have required medical attention or changes to medication for medical reasons within 90 days prior to consent 16. History of allergic reactions or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins 17. Receipt of any mAbs in the 12 months prior to Screening 18. High blood pressure 19. History of hyperprolinemia 20. Women who are either pregnant or breast-feeding 21. Vulnerable individuals (eg, military recruits, persons in compulsory detention, those with limited legal capacity) 22. Receipt of immunoglobulins or any blood products within 90 days prior to consent or planned receipt during the study period 23. 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 24. 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 25. Strenuous activity or contact sports within 48 hours before study drug dosing and through Day 8 26. History of relevant drug and/or food allergies

What this trial measures

  • Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults1) Local and systemic solicited AES from injection to Day 7, 2) All AEs post-injection to final visit at Week 48, 3) SAEs, MAAEs, and AESIs post-injection to final visit at Week 48

    1. Incidence of solicited local (injection site) and systemic AEs post-injection through Day 7 (with the inpatient and outpatient participant diaries being collected on Day 3 and Day 8, respectively). 2. Incidence of unsolicited AEs through end of study (EOS). 3. Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs) post-injection through EOS.