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

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

NCT Number	NCT06943378
Lead Sponsor	Just-Evotec Biologics
Conditions	Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Enrollment	104 participants
Start Date	2025-05-16
Primary Completion	2027-04 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-12