MedTrace Logo

Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults

NCT06943378 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-05-12

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-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

  • Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults

Interventions

BIOLOGICAL

Monoclonal antibody JST-010

Active study drug

DRUG

Placebo

Placebo

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
2025-05-16
Primary Completion
2027-04-30
Completion
2027-10-31
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 NCT06943378 on ClinicalTrials.gov