Study to Assess Safety and Effects of BY002 Compared to Placebo in Healthy Adults with Subcutaneous Injections

What this Trial Is About

Researchers are evaluating BY002, an investigational bispecific tandem VHH antibody targeting the CGRP receptor, to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy adult volunteers. This first-in-human, randomized, double-blind, placebo-controlled Phase 1 study includes a Single Ascending Dose SAD and a Multiple Ascending Dose MAD phase. The study also uses a capsaicin challenge test to measure how BY002 affects capsaicin-induced skin blood flow as a marker of its pharmacodynamic effect. Participants will receive single or multiple subcutaneous injections of BY002 or placebo in a randomized 31 ratio across various dose levels. The SAD phase consists of six dose cohorts ranging from 10 mg to 200 mg, with sentinel dosing to ensure safety before proceeding. Based on the SAD results, selected doses will be further studied in the MAD phase. Both phases may include capsaicin challenge tests to evaluate the drugs effect on skin blood flow. During the study, participants will be closely monitored for adverse events, injection site reactions, and serious adverse events for 7 days after the last dose. Assessments include pharmacokinetic analysis, immunogenicity testing, and pharmacodynamic evaluation through capsaicin-induced blood flow measurement. The total participation includes dosing and a 7-day safety follow-up period after the last administration to ensure participant safety and collect study data.

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