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Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults

NCT07595458 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-19

No results posted yet for this 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

Conditions

  • Antiviral Drug

Interventions

BIOLOGICAL

JST-018 combination of 3 monoclonal antibodies

Monoclonal antibodies

DRUG

Placebo

Placebo Comparator

Sponsors & Collaborators

  • Just-Evotec Biologics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-11
Primary Completion
2026-11-09
Completion
2027-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595458 on ClinicalTrials.gov