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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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 criteria

Qualifiers

1. Male or female aged ≥18 years at the time of signing the Informed Consent Form (ICF).

Disqualifiers

1. Individuals with a history or current presence of clinically significant cardiovascular (e.g., hypertension), pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatologic, psychiatric, systemic, ocular, reproductive, otorhinolaryngological, dermatological, or infectious diseases, or acute disease signs, unless deemed not clinically significant by the investigator and sponsor.

Trial design

Treatments tested in this trial

  • BY002
  • Placebo

Treatment groups

104 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

SDM Bioservices Inc.

Collaborator

Beijing Hikinge Pharmaceutical Technology Co., Ltd.

Collaborator

Biyopharma Co., LTD,Hangzhou, China

Collaborator