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JST-010

Phase 1

Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults | Monoclonal antibody | Other |Evotec SE|Last Updated: May 12, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as Monoclonal antibody JST-010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

JST-010 · 1 trial · 1 indication

Phase 1 1
NCT06943378Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy AdultsPre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
ACTIVE NOT_RECRUITING104 Analytics
PHASE1ACTIVE NOT_RECRUITING
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
NCT06943378104
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Study Endpoints

Primary Endpoints

Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults
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

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.

Secondary Endpoints

Pharmacokinetic Cmax of JST-010
From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-010
From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-010
From enrollment to the end of study at 48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
JST-010: The active investigational productACTIVE_COMPARATOR -
JST-012 PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Monoclonal antibody JST-010BIOLOGICALActive study drug
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy men or women 18 to 55 years of age 2. BMI between 18 and 32 kg/m2 3. Negative serum pregnancy test 4. 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 5. In g...

Countries:United States
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