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NCT07595458 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults
A Phase 1 study, sponsored by Just-Evotec Biologics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT07595458 is a Phase 1 study that is actively recruiting participants, run by Just-Evotec Biologics. The registered enrollment target is 48 participants.
The verdict
NCT07595458, a Phase 1 study, is actively recruiting participants, sponsored by Just-Evotec Biologics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if a single dose of the study drug, JST-018, 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 administration of JST-018 safe? * What is the concentration of the JST-018 in the blood over time? * Do antibodies to JST-018 develop following a dose of JST-018? Researchers will compare JST-018 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
Interventions
- DRUG Placebo
- BIOLOGICAL JST-018 combination of 3 monoclonal antibodies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-06-11 |
| Est. Completion | 2027-10-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07595458
The ClinicalTrials.gov registry entry for NCT07595458 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07595458 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07595458 about?
NCT07595458 is a clinical study titled "Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults". The goal of this clinical trial is to learn if a single dose of the study drug, JST-018, 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 administration of JST-018 safe? ...
What is the current status of trial NCT07595458?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-06-11. Estimated completion is 2027-10-04.
What interventions are being tested in trial NCT07595458?
The interventions under investigation include: Placebo (DRUG), JST-018 combination of 3 monoclonal antibodies (BIOLOGICAL).
Who is sponsoring clinical trial NCT07595458?
This trial is sponsored by Just-Evotec Biologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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