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A Phase I Study of XJ103 in Chinese Healthy Subjects

Primary Purpose

Pneumococcal Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
XJ103 Injection
Placebo
Sponsored by
Starmab biologics(Shanghai)Co,.ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumococcal Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18 through 45 years at screening. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including critical values). The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the informed consent form until the end of the trail. Healthy on the basis of physical examination and medical and surgical history and twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities. Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Exclusion Criteria: Subjects with any abnormalities of respiratory system, circulatory system, digestive system, nervous system, skeletal muscle system, blood and lymphatic system, immune system and endocrine system. History of allergy to drugs or biological products or individuals with allergic constitution. Acute infection within 4 weeks prior to study entry. Suffer from diseases caused by streptococcus pneumoniae within 1 year prior to study entry, such as pneumococcal pneumonia, pneumococcal meningitis, etc. Receipt of any standard vaccine against streptococcus pneumoniae before the study period. Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during the study period. Receipt of any major surgery within 3 months prior to the start of the trial, or have not recovered from surgery, or plan to have a surgical during the trial. Those who cannot tolerate venipuncture, or have a history of injector and blood sickness, or are not suitable for venous blood collection. Subjects with a history of drug abuse or drug use, or those with positive urine drug screening. Blood donation or massive blood loss (> 200 mL) within three months prior to screening or plan to donate blood, receive blood transfusions, or use blood products during the trial period or within 1 month after the end of the trial. Pregnant or lactating women. Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening. Smoke more than 5 cigarettes per day within three months prior to screening. Frequent drinkers in the three months before screening, i.e. those who drink more than or equal to 14 units of alcohol per week on average (1 unit=17.7 ml ethanol, 1 unit=354 ml beer with 5% alcohol, 44.25 ml spirits with 40% alcohol, or 147.5 ml wine with 12% alcohol), or those who do not agree to ban alcohol during the study period. Evidence of infection with HBV, hepatitis C, HIV, or syphilis. Positive alcohol breath test. Subjects with special dietary requirements or cannot accept a unified diet. Participation in other clinical trials within three months prior to enrollment or plan to participate in other clinical trials during this period. Any other factors evaluated by investigators that patients cannot be enrolled.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    XJ103 Injection

    Placebo

    Arm Description

    Participants will receive a single dose of XJ103 intravenously.

    Participants will receive a single dose of placebo intravenously.

    Outcomes

    Primary Outcome Measures

    Incidence of any adverse events that occurred among all subjects during the clinical trial

    Secondary Outcome Measures

    Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
    Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])
    Maximum Observed Serum Concentration (Cmax)
    Terminal Phase Elimination Half-life (t1/2)
    Elimination Rate Constant (Kel)
    Mean Residence Time (MRT)
    Apparent Serum Clearance (CL)
    Apparent Volume of Distribution (Vd)
    Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)
    Proportion of Participants Positive for Anti-drug Antibodies (ADA)
    Titer Range of Anti-drug Antibodies (ADA)

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Starmab biologics(Shanghai)Co,.ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06026748
    Brief Title
    A Phase I Study of XJ103 in Chinese Healthy Subjects
    Official Title
    A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ103 in Chinese Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 24, 2024 (Anticipated)
    Study Completion Date
    March 6, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Starmab biologics(Shanghai)Co,.ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumococcal Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    XJ103 Injection
    Arm Type
    Experimental
    Arm Description
    Participants will receive a single dose of XJ103 intravenously.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive a single dose of placebo intravenously.
    Intervention Type
    Drug
    Intervention Name(s)
    XJ103 Injection
    Intervention Description
    XJ103 is a humanized monoclonal antibody.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo contains only excipients.
    Primary Outcome Measure Information:
    Title
    Incidence of any adverse events that occurred among all subjects during the clinical trial
    Time Frame
    From the time of informed consent through 358 days post dose.
    Secondary Outcome Measure Information:
    Title
    Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Maximum Observed Serum Concentration (Cmax)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Terminal Phase Elimination Half-life (t1/2)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Elimination Rate Constant (Kel)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Mean Residence Time (MRT)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Apparent Serum Clearance (CL)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Apparent Volume of Distribution (Vd)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Proportion of Participants Positive for Anti-drug Antibodies (ADA)
    Time Frame
    From Day 1 through 358 days post dose.
    Title
    Titer Range of Anti-drug Antibodies (ADA)
    Time Frame
    From Day 1 through 358 days post dose.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 through 45 years at screening. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including critical values). The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the informed consent form until the end of the trail. Healthy on the basis of physical examination and medical and surgical history and twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities. Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Exclusion Criteria: Subjects with any abnormalities of respiratory system, circulatory system, digestive system, nervous system, skeletal muscle system, blood and lymphatic system, immune system and endocrine system. History of allergy to drugs or biological products or individuals with allergic constitution. Acute infection within 4 weeks prior to study entry. Suffer from diseases caused by streptococcus pneumoniae within 1 year prior to study entry, such as pneumococcal pneumonia, pneumococcal meningitis, etc. Receipt of any standard vaccine against streptococcus pneumoniae before the study period. Receipt of any standard vaccine within 4 weeks prior to investigational product dosing or plan to vaccinate during the study period. Receipt of any major surgery within 3 months prior to the start of the trial, or have not recovered from surgery, or plan to have a surgical during the trial. Those who cannot tolerate venipuncture, or have a history of injector and blood sickness, or are not suitable for venous blood collection. Subjects with a history of drug abuse or drug use, or those with positive urine drug screening. Blood donation or massive blood loss (> 200 mL) within three months prior to screening or plan to donate blood, receive blood transfusions, or use blood products during the trial period or within 1 month after the end of the trial. Pregnant or lactating women. Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 14 days prior to screening. Smoke more than 5 cigarettes per day within three months prior to screening. Frequent drinkers in the three months before screening, i.e. those who drink more than or equal to 14 units of alcohol per week on average (1 unit=17.7 ml ethanol, 1 unit=354 ml beer with 5% alcohol, 44.25 ml spirits with 40% alcohol, or 147.5 ml wine with 12% alcohol), or those who do not agree to ban alcohol during the study period. Evidence of infection with HBV, hepatitis C, HIV, or syphilis. Positive alcohol breath test. Subjects with special dietary requirements or cannot accept a unified diet. Participation in other clinical trials within three months prior to enrollment or plan to participate in other clinical trials during this period. Any other factors evaluated by investigators that patients cannot be enrolled.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sun yufang
    Phone
    +86 15137415798
    Email
    sunyufang@starmabbio.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ding xueying
    Organizational Affiliation
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    A Phase I Study of XJ103 in Chinese Healthy Subjects

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