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A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects

PHASE1RECRUITING

This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.

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Study details:

The single ascending dose study will comprise 4 dose cohorts of 8 healthy participants each. In each cohort, participants will be randomized to receive 9MW3811 or placebo by 6:2.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Male or female participants between 18 and 55 years of age, inclusive.
  • Male body weight ≥50.0 kg, or female body weight ≥45.0 kg, and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
  • In good health determined by the investigator based on a medical evaluation, including a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, laboratory evaluations.
  • Exclusion criteria

  • Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
  • Having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment.
  • Use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (Excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the PI or designee)
  • Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
  • Participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening
  • Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody
  • History of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (Morphine, Methamphetamine, Tetrahydrocannabinol acid, Cocaine)
  • Participants with a positive SARS-CoV-2 test prior to admission (polymerase chain reaction (PCR) and/or rapid antigen testing (RAT), per site policy and PI discretion)
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-03-20

    Primary completion: 2023-09-01

    Study completion finish: 2023-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05740475

    Intervention or treatment

    DRUG: 9MW3811 injection

    DRUG: Placebo

    Conditions

    • Pulmonary Fibrosis
    • Tumor
    Image related to Pulmonary Fibrosis
    • Condition: Pulmonary Fibrosis, Tumor

    • DRUG: 9MW3811 injection and other drugs

    • Randwick, New South Wales, Australia

    • Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

    Find a site

    Closest Location:

    Scientia Clinical Research

    Research sites nearby

    Select from list below to view details:

    • Scientia Clinical Research

      Randwick, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: 9MW3811 injection
    • single dose escalation for experimental drug
    DRUG: 9MW3811 injection
    • Single dose intravenously infused on day 1
    PLACEBO_COMPARATOR: placebo
    • matching placebo administration for control
    DRUG: Placebo
    • Single dose of matching placebo intravenously infused on day 1

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Incidence of adverse events (AEs) as assessed by CTCAE v5.0An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.up to Day113
    Number of participants with abnormal clinically significant results from physical examinationThe physical examinations will include examination of the following: head, eyes, ears, nose and throat, neck (including thyroid \& nodes), cardiovascular system, dermatological system, musculoskeletal system, respiratory system, gastrointestinal system, neurological system and renal system.up to Day113
    Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parametersThe examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF \[corrected by Fridericia formula, QTcF = QT/(RR\^0.33), RR is the standardized heart rate value, which is obtained by dividing 60 by the heart rate\].up to Day113
    Number of participants with abnormally clinical vital signsVital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.up to Day113
    Number of participants with abnormal clinically significant clinical laboratory resultsClinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.up to Day113

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Maximum Plasma Concentration (Cmax)To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Time to reach Cmax (Tmax)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Terminal elimination half-life (t1/2)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    AUC from time 0 extrapolated to infinity (AUC0-inf)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Terminal elimination rate constant (λz)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Apparent clearance (CL)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Volume of distribution (Vz)To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.up to Day 113
    Incidence of antidrug antibodies (ADA) at specified timepoints relative to baselineTo determine the immunogenicity of 9MW3811.up to Day 113

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects

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