Back to search results

Phase 1 Study of JST-018 for Antiviral Treatment

This study is testing a new antiviral drug called JST-018, which is a combination of three monoclonal antibodies (special proteins that can fight off infections). Researchers want to see if a single injection of JST-018 into the muscle is safe and well-tolerated in healthy adults. They will also look at how much JST-018 is in the blood over time and if the body makes antibodies against JST-018. Some participants will receive JST-018, while others will receive a placebo (an inactive substance) for comparison. The study is looking for 48 healthy men and women between 18 and 55 years old. To join, you must be in good general health and have a BMI between 18 and 32 kg/m2. The study's main goal is to understand the safety and tolerability of JST-018.

Study design
This is a Phase 1, randomized, double-blind, placebo-controlled study involving 48 healthy participants. It will test single ascending doses of JST-018.
What's involved
Participants will be confined to the clinic for the first 3 days after receiving an injection. Safety will be monitored from injection up to 48 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability from the time of injection until their final visit at Week 48.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07595458

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

Recruiting
PHASE1Ages 18–55InterventionalPrevention
Just-Evotec Biologics
~48 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:JST-018 combination of 3 monoclonal antibodiesPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of of JST-018 administered intramuscularly (IM)
Measured over From injection to Day 7
+5 more outcomes measured

Conditions

Antiviral Drug

Explore related trials

Healthy Volunteers

NCT07595458

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • PPD Las Vegas Clinical Research Unit

    Las Vegas, Nevadastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Nels Royer
[email protected]
(206)651-5094
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

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 8. Use of immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior to Screening. Nasal steroid use is permissible. 9. Upper arms and thighs are with insufficient muscular tissue for IM injections or is obscured by tattoos or rash 10. 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 11. Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody 12. 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 13. 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 14. 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 15. Progressive, unstable, or uncontrolled medical conditions that have required medical attention or changes to medication for medical reasons within 90 days prior to consent 16. History of allergic reactions or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins 17. Receipt of any mAbs in the 12 months prior to Screening 18. High blood pressure 19. Women who are either pregnant or breast-feeding 20. Vulnerable individuals (eg, military recruits, persons in compulsory detention, those with limited legal capacity) 21. Receipt of immunoglobulins or any blood products within 90 days prior to consent or planned receipt during the study period 22. Donation or loss of \>500 mL of blood within 30 days or plasma within 7 days of Day 1; any planned donation of blood or plasma during the study period 23. History of any malignant neoplasm within the last 5 years, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin or the cervix 24. Strenuous activity or contact sports within 48 hours before study drug dosing and through Day 8

What this trial measures

  • Safety and tolerability of of JST-018 administered intramuscularly (IM)From injection to Day 7

    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)

  • Safety and tolerability of of JST-018 administered IMFrom injection to final visit at Week 48

    Incidence of unsolicited AEs through end of study (EOS)

  • Safety and tolerability of of JST-018 administered IMFrom injection to final visit at Week 48

    Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs)

  • Safety and tolerability of of JST-018 administered IMFrom injection to final visit at Week 48

    Incidence of Clinically Significant Changes in Laboratory Values

  • Safety and tolerability of JST-018 administered as IMFrom injection to final visit at Week 48

    Incidence of Clinically Significant Changes in Vital Sign Measurements

  • Safety and tolerability of JST-018 administered as IMFrom injection to final visit at Week 48

    Incidence of Clinically Significant Changes in ECG results