JST-010 for Preventive Treatment

Overseen By Dennis Miller, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Just-Evotec Biologics

Must not be taking: Steroids, Immunosuppressants, Anticoagulants, others

Disqualifiers: Immunodeficiency, Transplant, HIV, others

Compensation: Varies

Number of Visits: 12

Duration: 3 days

104 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that you started within 30 days before the trial begins, except for vitamin supplements and certain pain relievers like acetaminophen and NSAIDs, which have specific restrictions.

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for healthy adults aged 18 to 55 who can participate in a study involving an injection of the monoclonal antibody JST-010, potentially preventing bubonic and pneumonic plague. Participants must be available for an initial clinic confinement of 3 days followed by multiple follow-up visits over a year.

Inclusion Criteria

BMI between 18 and 32 kg/m2

Negative serum pregnancy test

Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence

Exclusion Criteria

History of relevant drug and/or food allergies

Positive human immunodeficiency virus (HIV-1/-2) antibody result by history or at Screening

Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of JST-010 or placebo administered intramuscularly, followed by safety monitoring

3 days

In-clinic confinement for 3 days

Follow-up

Participants are monitored for safety and pharmacokinetics, including physical exams, ECGs, and lab tests

48 weeks

9 visits over 1 year

Treatment Details

Interventions

• JST-010

Trial Overview The trial tests the safety and blood concentration over time of JST-010 after a single dose compared to placebo. It involves close monitoring through physical exams, ECGs, blood and urine samples, and checks for any adverse effects or development of antibodies against JST-010.

Participant Groups

Group I: JST-010: The active investigational product Active Control 1 Intervention

Group II: JST-012 Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Just-Evotec Biologics

Lead Sponsor