RecruitingPhase 1NCT07640438

Healthy Participants Randomized, Double-blind, Placebo-controlled, Phase Ⅰ

A Phase Ⅰ Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of BY002 in Healthy Participants


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

104 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this clinical trial is to evaluate the safety and tolerability of BY002 in healthy subjects. Investigators will compare BY002 to a placebo (a pharmacologically inactive substance) to assess the safety and tolerability of BY002 in healthy subjects. Participants will undergo: 1. Single/multiple subcutaneous (SC) administrations of BY002/placebo 2. A 7-day safety follow-up period following the last dose


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BY002 and a drug called Placebo for people with healthy participants study. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBY002

BY002, administered via subcutaneous (SC) injection as single or multiple doses according to the clinical trial protocol.

DRUGPlacebo

Placebo, administered via subcutaneous (SC) injection as single or multiple doses according to the clinical trial protocol.


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07640438


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