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Antiviral DrugFirst-in-humanHealthy volunteersBiologicalDrugPhase 1

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 ↗