What this study is
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
What's being tested
- JST-018 combination of 3 monoclonal antibodies
Intervention · BIOLOGICAL
Monoclonal antibodies
- Placebo
Intervention · DRUG
Placebo Comparator
Study details
- Official title
- Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults
- Sponsor
- Just-Evotec Biologics
- Conditions
- Antiviral Drug
- Enrolling
- 48 people
- Starts
- 2026-06-23
- Est. completion
- 2027-10-04
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers AcceptedYou 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 can't join 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
- History of allergic reactions or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins
- Receipt of any mAbs in the 12 months prior to Screening
- High blood pressure
- Women who are either pregnant or breast-feeding
- Vulnerable individuals (eg, military recruits, persons in compulsory detention, those with limited legal capacity)
- Receipt of immunoglobulins or any blood products within 90 days prior to consent or planned receipt during the study period
- 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
- 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
- Strenuous activity or contact sports within 48 hours before study drug dosing and through Day 8
- History of relevant drug and/or food allergies
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open- Recruiting
Study team
Sponsor
Just-Evotec Biologics
Study ID DDF4-CL101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.