Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Dose Expansion Study to Assess the Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody, JST-010, in Healthy Adults
Just-Evotec Biologics
Summary
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, 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 injection of JST-010 safe? * What is the concentration of the JST-01 in the blood over time? * Do antibodies to JST-010 develop following a dose of JST-010? Researchers will compare JST-010 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
Description
This is a two-part, Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) (Part 1) and dose expansion (Part 2) study to assess the safety, tolerability, and PK of a single dose of JST-010 administered IM to healthy participants. Part 1 will comprise a minimum of 3 SAD cohorts (Cohorts A, B, and C, with 14 participants per cohort), each evaluating a single dose of JST-010 administered IM. In each SAD cohort, 2 sentinel participants will be randomized 1:1 such that one participant receives JST-010 and 1 participant receives placebo. Following a…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Healthy men or women 18 to 55 years of age 2. BMI between 18 and 32 kg/m2 3. Negative serum pregnancy test 4. 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 5. In good general health as determined by medical history, exams and tests Exclusion Criteria: 1. Acute illness or fever (≥100.4°F) within 7 days prior to dosing 2. Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against the Yersinia pestis bacterium 3. Receipt of any vaccin…
Interventions
- BiologicalMonoclonal antibody JST-010
Active study drug
- DrugPlacebo
Placebo
Location
- PPD Las Vegas Clinical Research UnitLas Vegas, Nevada