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RECRUITING
NCT06943378
PHASE1

Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults

Sponsor: Just-Evotec Biologics

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-05-16

Completion Date

2027-10

Last Updated

2025-06-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Monoclonal antibody JST-010

Active study drug

DRUG

Placebo

Placebo

Locations (1)

PPD Las Vegas Clinical Research Unit

Las Vegas, Nevada, United States