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

NCT07640438 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-06-10

No results posted yet for this study

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

Conditions

  • Healthy Participants Study

Interventions

DRUG

BY002

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

DRUG

Placebo

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

Sponsors & Collaborators

  • SDM Bioservices Inc.

    collaborator UNKNOWN

  • Beijing Hikinge Pharmaceutical Technology Co., Ltd.

    collaborator UNKNOWN

  • Biyopharma Co., LTD，Hangzhou， China

    collaborator UNKNOWN

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-11-30
Completion
2027-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640438 on ClinicalTrials.gov