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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 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. The trial reports 1 study location across 1 state.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06943378
The ClinicalTrials.gov registry entry for NCT06943378 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Just-Evotec Biologics, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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