Healthy Participants StudyPhase 1NCT07640438
Healthy Participants Randomized, Double-blind, Placebo-controlled, Phase Ⅰ
A Phase 1 study testing BY002 in people with Healthy Participants Study, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- BY002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Male or female aged ≥18 years at the time of signing the Informed Consent Form (ICF).
- 2. 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.
- 3. 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.
- 4. 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.
- 5. 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).
- 6. Provide written informed consent before any study-related procedures are performed.
Who cannot join
- 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.
- 2. 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.
- 3. 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.).
- 4. 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.
- 5. 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.
- 6. History of drug abuse within 12 months prior to screening, or positive urine drug screen result.
Show all 16Show fewer
- 7. 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.
- 8. The investigator determines that the participant's skin characteristics are unsuitable for capsaicin skin challenge (applicable only to participants undergoing the capsaicin challenge test).
- 9. Participants for whom venous blood collection is difficult.
- 10. 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.
- 11. 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).
- 12. 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).
- 13. 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.
- 14. Receipt of any vaccine within 2 weeks prior to the first dose of the investigational drug.
- 15. 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).
- 16. Individuals deemed by the investigator to be likely noncompliant during the study period, or unable to cooperate due to language barriers or intellectual disability, or otherwise unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 31003
Jian Liu, 0571-87236560, lindaliu87@zju.edu.cn
About this study
Official title: A Phase Ⅰ Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of BY002 in Healthy Participants
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:
- Single/multiple subcutaneous (SC) administrations of BY002/placebo
- A 7-day safety follow-up period following the last dose
Read the detailed description
This first-in-human (FIH), randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BY002 (an investigational, bispecific tandem VHH antibody targeting the CGRP receptor) in healthy adult subjects. This Phase 1 study consists of two parts: a Single Ascending Dose (SAD) study and a Multiple Ascending Dose (MAD) study. Furthermore, both the SAD and MAD studies incorporate a capsaicin challenge test to assess the inhibitory effect of BY002 on capsaicin-induced elevation of dermal blood flow (DBF), serving as a PD marker for CGRP receptor antagonism.
- Conditions
- Healthy Participants Study
- Being tested
- BY002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BY002Drug
BY002, administered via subcutaneous (SC) injection as single or multiple doses according to the clinical trial protocol.
PlaceboDrug
Placebo, administered via subcutaneous (SC) injection as single or multiple doses according to the clinical trial protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: BY002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after the last dose
Secondary outcomes (11)
pharmacokinetics (PK) analysis
Time to maximum observed plasma concentration
Measured: 7 days after the last dose
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.
Measured: 7 days after the last dose
Measurement of immunogenicity of BY002.
Development of anti-drug antibodies (ADA) post-dose.
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Maximum observed plasma concentration
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Area under the concentration-time curve from time zero to the last measurable concentration
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Area under the concentration-time curve from time zero extrapolated to infinity
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Terminal elimination half-life
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Apparent volume of distribution (after non-intravenous administration)
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Mean residence time (MRT)
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Terminal elimination rate constant
Measured: 7 days after the last dose
pharmacokinetics (PK) analysis
Percentage of extrapolated area under the curve
Measured: 7 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose escalation design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- SDM Bioservices Inc., Beijing Hikinge Pharmaceutical Technology Co., Ltd., Biyopharma Co., LTD，Hangzhou， China
- Responsible party
- Principal investigator, Jian Liu, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640438
- Sponsor's protocol ID
- BY002-161
- Status last verified
- Jun 2026
- First submitted
- 30 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of BY002 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07640438
- Acronym / sponsor ID
- BY002-161
- Conditions
- Healthy Participants Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- SDM Bioservices Inc., Beijing Hikinge Pharmaceutical Technology Co., Ltd., Biyopharma Co., LTD，Hangzhou， China
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Single/multiple subcutaneous (SC) administrations of BY002/placebo
- A 7-day safety follow-up period following the last dose
Detailed description
This first-in-human (FIH), randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BY002 (an investigational, bispecific tandem VHH antibody targeting the CGRP receptor) in healthy adult subjects. This Phase 1 study consists of two parts: a Single Ascending Dose (SAD) study and a Multiple Ascending Dose (MAD) study. Furthermore, both the SAD and MAD studies incorporate a capsaicin challenge test to assess the inhibitory effect of BY002 on capsaicin-induced elevation of dermal blood flow (DBF), serving as a PD marker for CGRP receptor antagonism.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Capsaicin challenge test-placebo | Placebo comparator | Drug: PlaceboDuring 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. |
| Multiple Ascending Dose (MAD)-placebo | Placebo comparator | Drug: PlaceboBased 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. |
| Single Ascending Dose (SAD)-placebo | Placebo comparator | Drug: PlaceboThe 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. |
| Capsaicin challenge test | Experimental | Drug: BY002During 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. |
| Multiple Ascending Dose (MAD) | Experimental | Drug: BY002Based 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. |
| Single Ascending Dose (SAD) | Experimental | Drug: BY002The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Male or female aged ≥18 years at the time of signing the Informed Consent Form (ICF).
- 2. 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.
- 3. 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.
- 4. 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.
- 5. 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).
Key exclusion criteria (16 listed)
- 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.
- 2. 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.
- 3. 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.).
- 4. 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.
- 5. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BY002BY002, administered via subcutaneous (SC) injection as single or multiple doses according to the clinical trial protocol. | Drug | Capsaicin challenge test, Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
| PlaceboPlacebo, administered via subcutaneous (SC) injection as single or multiple doses according to the clinical trial protocol. | Drug | Capsaicin challenge test-placebo, Multiple Ascending Dose (MAD)-placebo, Single Ascending Dose (SAD)-placebo |
Primary outcome
Incidence of adverse events (AEs), injection site reactions (ISRs), and serious adverse events (SAEs). [Safety and Tolerability]
Time frame: 7 days after the last dose
Incidence of clinically significant abnormal changes in vital signs, physical examinations, laboratory evaluations, 12-lead electrocardiograms (12-lead ECGs), and other safety parameters.
11 secondary outcomes
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
Measurement of capsaicin-induced cutaneous blood flow. (pharmacodynamic [PD] endpoint)
Time frame: 7 days after the last dose
Measurement of immunogenicity of BY002.
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
pharmacokinetics (PK) analysis
Time frame: 7 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants Study
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Visual Attention, Object Recognition, and Eye Movements in Healthy Volunteers
Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BY002 in people with Healthy Participants Study, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Liu (0571-87236560, lindaliu87@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs), injection site reactions (ISRs), and serious adverse events (SAEs). [Safety and Tolerability] (time frame: 7 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.