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

NCT07640438 | Recruiting Phase 1

• 1 other identifier: BY002-161
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 1.Single/multiple subcutaneous (SC) administrations of BY002/placebo
2. 2.A 7-day safety follow-up period following the last dose

Conditions

Healthy Participants Study

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs), injection site reactions (ISRs), and serious adverse events (SAEs). [Safety and Tolerability]

  Incidence of clinically significant abnormal changes in vital signs, physical examinations, laboratory evaluations, 12-lead electrocardiograms (12-lead ECGs), and other safety parameters.

  7 days after the last dose

Secondary Outcomes (11)

• pharmacokinetics (PK) analysis

  7 days after the last dose

• Measurement of capsaicin-induced cutaneous blood flow. (pharmacodynamic [PD] endpoint)

  7 days after the last dose

• Measurement of immunogenicity of BY002.

  7 days after the last dose

• pharmacokinetics (PK) analysis

  7 days after the last dose

• pharmacokinetics (PK) analysis

  7 days after the last dose

Study Arms (6)

Capsaicin challenge test-placebo

PLACEBO COMPARATOR

During the SAD/MAD dose escalation phase, based on accumulated safety and pharmacokinetic (PK) data, the SRC will decide whether to initiate the capsaicin challenge test (conducting the single-dose and multiple-dose capsaicin challenge tests, respectively) and select the dose cohorts. Eight healthy participants will be randomized into each cohort, of whom 6 will receive the selected dose of BY002 and 2 will receive a placebo.

Drug: Placebo

Multiple Ascending Dose (MAD)-placebo

PLACEBO COMPARATOR

Based on the safety, tolerability, PK, PD, and other data obtained from the SAD study, 2-3 doses will be selected during the SAD dose escalation phase for further evaluation in the MAD study. Each cohort is planned to enroll 8 healthy participants, who will be randomized to the BY002 or placebo group in a 3:1 ratio.

Drug: Placebo

Single Ascending Dose (SAD)-placebo

PLACEBO COMPARATOR

The SAD study will consist of 6 dose cohorts (10 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg), with a planned enrollment of 48 healthy participants who will be randomized to the BY002 or placebo group in a 3:1 ratio. The SAD study will initiate with the lowest dose cohort and proceed sequentially. In each dose cohort, 8 healthy participants will be randomized in a double-blind manner, of whom 6 will receive BY002 and 2 will receive a placebo. A sentinel dosing strategy will be utilized for each dose cohort, whereby 2 participants will be enrolled first to receive a subcutaneous injection of BY002 or placebo. At least 24 hours post-dose, if safety is confirmed by the investigator, the remaining participants in the same dose-level cohort may proceed with enrollment and receive the investigational product according to the study design and methodology.

Drug: Placebo

Capsaicin challenge test

EXPERIMENTAL

During the SAD/MAD dose escalation phase, based on accumulated safety and pharmacokinetic (PK) data, the SRC will decide whether to initiate the capsaicin challenge test (conducting the single-dose and multiple-dose capsaicin challenge tests, respectively) and select the dose cohorts. Eight healthy participants will be randomized into each cohort, of whom 6 will receive the selected dose of BY002 and 2 will receive a placebo.

Drug: BY002

Multiple Ascending Dose (MAD)

EXPERIMENTAL

Based on the safety, tolerability, PK, PD, and other data obtained from the SAD study, 2-3 doses will be selected during the SAD dose escalation phase for further evaluation in the MAD study. Each cohort is planned to enroll 8 healthy participants, who will be randomized to the BY002 or placebo group in a 3:1 ratio.

Drug: BY002

Single Ascending Dose (SAD)

EXPERIMENTAL

The SAD study will consist of 6 dose cohorts (10 mg, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg), with a planned enrollment of 48 healthy participants who will be randomized to the BY002 or placebo group in a 3:1 ratio. The SAD study will initiate with the lowest dose cohort and proceed sequentially. In each dose cohort, 8 healthy participants will be randomized in a double-blind manner, of whom 6 will receive BY002 and 2 will receive a placebo. A sentinel dosing strategy will be utilized for each dose cohort, whereby 2 participants will be enrolled first to receive a subcutaneous injection of BY002 or placebo. At least 24 hours post-dose, if safety is confirmed by the investigator, the remaining participants in the same dose-level cohort may proceed with enrollment and receive the investigational product according to the study design and methodology.

Drug: BY002

Interventions

BY002 DRUG

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

Capsaicin challenge test; Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Placebo DRUG

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

Capsaicin challenge test-placebo; Multiple Ascending Dose (MAD)-placebo; Single Ascending Dose (SAD)-placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female aged ≥18 years at the time of signing the Informed Consent Form (ICF).
• \. At screening, body mass index (BMI) between 18 and 30 kg/m² (inclusive), with weight ≥50.0 kg for males and ≥45.0 kg for females.
• \. Good health status determined by screening examinations. Good health status is defined as: absence of clinically relevant abnormalities or psychiatric diseases that, in the investigator's judgment, could compromise participant safety, affect the scientific validity of the study, expose the participant to unacceptable risk, or interfere with their compliance with study procedures and restrictions.
• \. Male participants and their partners of childbearing potential must agree to use highly effective contraception during the study and for at least 12 weeks after the last dose. Male participants must refrain from donating sperm during this period. Female participants must not be pregnant or lactating. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and be willing to use highly effective contraception throughout the study and for at least 12 weeks after the last dose. Female participants must avoid donating eggs during this period.
• \. Participants who, after capsaicin challenge during screening, meet the criteria specified in the Capsaicin Challenge Test Operating Manual (applicable only to participants undergoing the capsaicin challenge test).
• \. Provide written informed consent before any study-related procedures are performed.

You may not qualify if:

• \. 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.
• \. Individuals who have donated blood (≥400 mL) or experienced significant blood loss (≥400 mL), donated ≥2 units of blood components, or received a blood transfusion within 2 months prior to the first dose of investigational drug; or who plan to donate blood during the study.
• \. Individuals with allergic constitution (defined as a clear history of allergy to two or more drugs, or to two or more common foods, or to common inhaled/contact irritants such as pollen, dust mites, pet dander, mold, etc.), or a known history of allergic reactions to any therapeutic protein drugs (including monoclonal antibodies, fusion proteins, recombinant enzymes, cytokines, peptide hormones, blood products, vaccines, etc.).
• \. Participants who are known to be allergic to any component of the investigational drug product or to capsaicin (applicable only to participants undergoing the capsaicin challenge test), or who have other contraindications.
• \. Alcohol abuse or frequent alcohol consumption within 6 months prior to screening, defined as weekly alcohol intake exceeding 14 units (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), or unwillingness to abstain from alcohol and any alcohol-containing products during the study; or a positive alcohol breath test.
• \. History of drug abuse within 12 months prior to screening, or positive urine drug screen result.
• \. Smokers (defined as consuming more than 5 cigarettes or equivalent products per week), or those who cannot discontinue the use of any tobacco products during the study period.
• \. The investigator determines that the participant's skin characteristics are unsuitable for capsaicin skin challenge (applicable only to participants undergoing the capsaicin challenge test).
• \. Participants for whom venous blood collection is difficult.
• \. Individuals who, as judged by the investigator, have clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), or chest X-ray at screening.
• \. Individuals with a QT interval corrected using Fridericia's formula (QTcF) \>450 ms for male participants or \>470 ms for female participants on the screening electrocardiogram (ECG).
• \. Positive result in any of the following tests: Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibody, anti-human immunodeficiency virus antibody (anti-HIV Ab), and specific antibody to Treponema pallidum (TP-Ab).
• \. Individuals who have used any prescription medication, over-the-counter (OTC) drugs, traditional Chinese patent medicines, Chinese herbal medicines, vitamins, or dietary supplements within 14 days prior to the first dose or within 5 elimination half-lives or pharmacodynamic half-lives (whichever is longer) that may interfere with the study assessments.
• \. Receipt of any vaccine within 2 weeks prior to the first dose of the investigational drug.
• \. Individuals who have enrolled in or participated in any clinical trial containing investigational drugs or other medical research within 1 month prior to the first dose, or within 5 elimination half-lives (whichever is longer).

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• SDM Bioservices Inc.: collaborator
• Beijing Hikinge Pharmaceutical Technology Co., Ltd.: collaborator
• Biyopharma Co., LTD，Hangzhou， China: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 31003, China

RECRUITING

Central Study Contacts

Jian Liu

CONTACT

0571-87236560; lindaliu87@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: sponsor、CRO
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pharmacist

Model Details: Dose escalation design

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)