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NCT06943378 · ClinicalTrials.gov registry record · Phase 1
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
A Phase 1 study of Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults, sponsored by Just-Evotec Biologics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT06943378: Recruiting Phase 1 study of Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults, sponsored by Just-Evotec Biologics.
NCT06943378 is a Phase 1 study of Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults that is actively recruiting participants, run by Just-Evotec Biologics. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06943378, a Phase 1 study of Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults, is actively recruiting participants, sponsored by Just-Evotec Biologics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Monoclonal antibody JST-010
Study Locations (1)
Nevada
- PPD Las Vegas Clinical Research Unit - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2025-05-16 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
What NCT06943378 shows while recruiting
NCT06943378 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).
The record links to 1 condition, with Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06943378 reports a single indexed study location in Nevada.
Frequently Asked Questions
What is clinical trial NCT06943378 about?
NCT06943378 is a clinical study titled "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? * Wha...
What is the current status of trial NCT06943378?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2025-05-16. Estimated completion is 2027-10.
What conditions does trial NCT06943378 study?
This clinical trial studies the following conditions: Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults.
What interventions are being tested in trial NCT06943378?
The interventions under investigation include: Placebo (DRUG), Monoclonal antibody JST-010 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06943378?
This trial is sponsored by Just-Evotec Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06943378 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06943378's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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