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

Primary Purpose

Pulmonary Fibrosis, Tumor

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
9MW3811 injection
Placebo
Sponsored by
Mabwell (Shanghai) Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Scientia Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

9MW3811 injection

placebo

Arm Description

single dose escalation for experimental drug

matching placebo administration for control

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs) as assessed by CTCAE v5.0
An 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.
Number of participants with abnormal clinically significant results from physical examination
The 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.
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
The 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].
Number of participants with abnormally clinical vital signs
Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.
Number of participants with abnormal clinically significant clinical laboratory results
Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time to reach Cmax (Tmax)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
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.
Terminal elimination half-life (t1/2)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
AUC from time 0 extrapolated to infinity (AUC0-inf)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Terminal elimination rate constant (λz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Apparent clearance (CL)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Volume of distribution (Vz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.

Full Information

First Posted
February 2, 2023
Last Updated
June 12, 2023
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05740475
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
Official Title
A Phase 1, First-in-human, Randomized, Double-blind,Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Adult Participants
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
9MW3811 injection
Arm Type
Experimental
Arm Description
single dose escalation for experimental drug
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo administration for control
Intervention Type
Drug
Intervention Name(s)
9MW3811 injection
Intervention Description
Single dose intravenously infused on day 1
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of matching placebo intravenously infused on day 1
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
Description
An 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.
Time Frame
up to Day113
Title
Number of participants with abnormal clinically significant results from physical examination
Description
The 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.
Time Frame
up to Day113
Title
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Description
The 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].
Time Frame
up to Day113
Title
Number of participants with abnormally clinical vital signs
Description
Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.
Time Frame
up to Day113
Title
Number of participants with abnormal clinically significant clinical laboratory results
Description
Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.
Time Frame
up to Day113
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Time to reach Cmax (Tmax)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Terminal elimination half-life (t1/2)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
AUC from time 0 extrapolated to infinity (AUC0-inf)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Terminal elimination rate constant (λz)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Apparent clearance (CL)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Volume of distribution (Vz)
Description
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time Frame
up to Day 113
Title
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
Description
To determine the immunogenicity of 9MW3811.
Time Frame
up to Day 113
Other Pre-specified Outcome Measures:
Title
Serum interleukin-11 (IL-11) level after administration at specified timepoints relative to baseline
Description
To explore the pharmacodynamics (PD) of 9MW3811.
Time Frame
up to Day 113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Argent
Phone
02 9382 5844
Email
christopher.argent@scientiaclinicalresearch.com.au
Facility Information:
Facility Name
Scientia Clinical Research
City
Randwick
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PUJA MOTWANI
Email
puja.motwani@scientiaclinicalresearch.com.au
First Name & Middle Initial & Last Name & Degree
Christopher Argent

12. IPD Sharing Statement

Plan to Share IPD
No

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

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