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

ConditionHealthy Participants Study
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • BY002

    Drug

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

  • Placebo

    Drug

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

Treatment groups

104 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Capsaicin challenge test-placeboPlacebo comparator 1 intervention
Group B: Multiple Ascending Dose (MAD)-placeboPlacebo comparator 1 intervention
Group C: Single Ascending Dose (SAD)-placeboPlacebo comparator 1 intervention
Group D: Capsaicin challenge testExperimental treatment 1 intervention
Group E: Multiple Ascending Dose (MAD)Experimental treatment 1 intervention
Group F: Single Ascending Dose (SAD)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
7 days after the last dose

Secondary outcomes

1

pharmacokinetics (PK) analysis

Time to maximum observed plasma concentration

Time frame
7 days after the last dose
2

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

Area under the DBF curve (DBFAUC(t)) at each evaluation time point compared with placebo. Percentage inhibition of DBF.

Time frame
7 days after the last dose
3

Measurement of immunogenicity of BY002.

Development of anti-drug antibodies (ADA) post-dose.

Time frame
7 days after the last dose
4

pharmacokinetics (PK) analysis

Maximum observed plasma concentration

Time frame
7 days after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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