Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JST-018 · 1 trial · 1 indication
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)
Incidence of unsolicited AEs through end of study (EOS)
Incidence of Clinically Significant Changes in Vital Sign Measurements
| Arm | Type | Description |
|---|---|---|
| JST-018 Investigational Product | ACTIVE_COMPARATOR | - |
| JST-017 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JST-018 combination of 3 monoclonal antibodies | BIOLOGICAL | Monoclonal antibodies |
| Placebo | DRUG | Placebo Comparator |
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...
JST-018 is an investigational monoclonal antibody combination developed by Evotec SE for antiviral use in infectious disease. It is a combination of three monoclonal antibodies and is currently in Phase 1 clinical development. It has not been approved by the FDA and remains under study in healthy adult volunteers.
JST-018 is being developed as an antiviral drug for infectious disease, specifically targeting orthopoxviruses. Its only clinical study to date enrolls healthy adult volunteers rather than patients, so its use in treating any specific condition has not yet been established. It remains investigational.
JST-018 targets orthopoxviruses. It is a monoclonal antibody combination made up of three monoclonal antibodies directed at this virus class, which places it in the antiviral therapeutic area. Targeting the virus itself is the basis for its development as an infectious disease treatment.
Evotec SE, which trades under the ticker EVO, is the developer of JST-018. The company is advancing the monoclonal antibody combination as an antiviral candidate for orthopoxviruses. It is the sole developer named for this asset.
JST-018 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program has one active trial and no completed trials, with a total planned enrollment of 48 participants across that study.
JST-018 is being studied in NCT07595458, a Phase 1 trial titled a study on the safety, tolerability, and pharmacokinetics of JST-018 in healthy adults. The trial is recruiting in the United States, is randomized, double blind, and placebo controlled, and plans to enroll 48 participants aged 18 years and older.