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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Antiviral Drug

In brief

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

Key facts

Study ID

NCT07595458

Run by

Just-Evotec Biologics

People needed

48

Starts

2026-06-23

Expected to finish

2027-10-04

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men or women 18 to 55 years of age
• 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
• In good general health as determined by medical history, exams and tests

You may not qualify if…

• Acute illness or fever (≥100.4°F) within 7 days prior to dosing
• Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against smallpox, monkeypox, or other orthopox viruses.
• Receipt of any vaccine within 30 days prior to Screening, planned receipt of any vaccine prior to Day 1, or planned receipt of any vaccines before 45 days post-injection.
• Any medical condition for which IM injections would be contraindicated in the opinion of the investigator (eg, bleeding disorders, anticoagulant therapy, and severe thrombocytopenia)
• History of congenital or acquired immunodeficiency syndrome, , including positive human immunodeficiency virus (HIV-1/-2) antibody result
• Prior solid organ or bone marrow transplant
• Clinically significant corneal or lens abnormality as determined by history, clinical examination, or diagnostic imaging. Including, but not limited to:
• Corrected vision of less (worse) than 20/40
• History of any clinically significant history of eye trauma, in the opinion of the investigator
• History of cataracts or current cataracts
• Lens opacity greater than NC2, C2, or P0 as determined by the Lens Opacities Classification System (LOCS) III
• History of uveitis (including acute)
• Use of ocular or inhaled prescription steroids within 1 year prior to Screening nasal steroids are permissible). A single short course (ie, less than 14 days) of systemic steroid therapy is allowed provided it is concluded more than 6 months prior to Screening.
• History of diabetes
• Use of immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior to Screening. Nasal steroid use is permissible.
• Upper arms and thighs are with insufficient muscular tissue for IM injections or is obscured by tattoos or rash
• Use of any medications started within 30 days prior to Day -1, including prescription medications, nutritional supplements, and over-the-counter medications
• Vitamin supplements are allowed
• Recommended doses of acetaminophen are allowed, except for 24 hours prior to dosing
• Recommended doses of non-steroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen) are also allowed, except for 7 days prior to dosing
• Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody
• Positive urine drug test or cotinine (indicating active current smoking) at Screening or Day -1, positive alcohol breath test at Screening or on Day -1, or suspected/known drug abuse and/or alcohol use disorder
• Smoking or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months before study drug dosing
• Dosing in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of receiving the investigational drug prior to Screening
• Progressive, unstable, or uncontrolled medical conditions that have required medical attention or changes to medication for medical reasons within 90 days prior to consent

Where it is running

• PPD Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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