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Also known as Monoclonal antibody JST-010
JST-010 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| JST-010: The active investigational product | ACTIVE_COMPARATOR | - |
| JST-012 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Monoclonal antibody JST-010 | BIOLOGICAL | Active study drug |
| Placebo | DRUG | Placebo |
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-010 is an investigational monoclonal antibody being developed for pre-exposure prophylaxis against pneumonic plague in healthy adults. It is administered to prevent infection before exposure rather than to treat active disease. Evotec SE is developing the asset, which is currently in Phase 1 clinical testing in the United States.
JST-010 is being studied for pre-exposure prophylaxis against pneumonic plague in healthy adults. The goal is to protect people before they are exposed to the bacterium that causes pneumonic plague. It is not approved for any use and remains an investigational product in early clinical development.
Evotec SE, which trades under the ticker EVO, is the developer of JST-010. The company is running the monoclonal antibody program and is listed as the sponsor of the Phase 1 study evaluating the candidate in healthy adult volunteers.
JST-010 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single ongoing trial is a Phase 1 dose escalation and expansion study in healthy adults, and it is currently active but no longer recruiting participants.
JST-010 is being evaluated in one clinical trial, NCT06943378. The study is a Phase 1 randomized, double-blind, placebo-controlled dose escalation and expansion trial assessing the safety and pharmacokinetics of JST-010 in healthy adults. It has an enrollment of 104 participants and is being conducted in the United States.
Yes. JST-010 is also referred to as monoclonal antibody JST-010. Both names describe the same investigational antibody candidate developed by Evotec SE for pre-exposure prophylaxis against pneumonic plague, so searches using either name refer to the same Phase 1 asset.