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JST-018

Phase 1

Antiviral Drug | Monoclonal antibody | Infectious Disease |Evotec SE|Last Updated: Aug 5, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

JST-018 · 1 trial · 1 indication

Phase 1 1
NCT07595458Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy AdultsAntiviral Drug
RECRUITING48 Analytics
PHASE1RECRUITING
Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults
Antiviral Drug
NCT0759545848
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Study Endpoints

Primary Endpoints

Safety and tolerability of of JST-018 administered intramuscularly (IM)
From injection to Day 7

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)

Safety and tolerability of of JST-018 administered IM
From injection to final visit at Week 48

Incidence of unsolicited AEs through end of study (EOS)

Safety and tolerability of JST-018 administered as IM
From injection to final visit at Week 48

Incidence of Clinically Significant Changes in Vital Sign Measurements

Secondary Endpoints

Pharmacokinetic Cmax of JST-018
From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-018
Time Frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-018
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-018 Investigational ProductACTIVE_COMPARATOR -
JST-017 PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
JST-018 combination of 3 monoclonal antibodiesBIOLOGICALMonoclonal antibodies
PlaceboDRUGPlacebo Comparator
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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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Recent Changes (Last 90 Days)

LOWAug 5, 2026NCT07595458startDate: changed
LOWAug 3, 2026NCT07595458Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 3, 2026NCT07595458Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 3, 2026NCT07595458Status: NOT_YET_RECRUITING → RECRUITING