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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: Recruiting Phase 1 study, sponsored by Just-Evotec Biologics.
NCT07595458 is a Phase 1 study that is actively recruiting participants, run by Just-Evotec Biologics. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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)
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 |
What NCT07595458 shows while recruiting
NCT07595458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07595458 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07595458's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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