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

Conditions

• Antiviral Drug

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• JST-018 combination of 3 monoclonal antibodies — BIOLOGICAL
  Monoclonal antibodies
• Placebo — DRUG
  Placebo Comparator

Study Details

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 Dates

Start date

Jun 11, 2026

Status verified

May 2026

Primary completion

Nov 9, 2026

Completion

Oct 4, 2027

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: JST-018 Investigational Product
• Placebo Comparator: JST-017 Placebo

Primary Outcome Measure

Safety and tolerability of of JST-018 administered intramuscularly (IM) [ Time Frame: From injection to Day 7 ]

Central Contacts

• Nels Royer
  (206)651-5094
  [email protected]

Locations (1)

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