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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Fibrosis; Tumor
• Intervention / Treatment: Drug: 9MW3811 injection; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia
      • Scientia Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female participants between 18 and 55 years of age, inclusive.
2. 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.
3. 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:

1. Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
2. 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.
3. 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)
4. Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
5. 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
6. 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
7. 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)
8. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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 Measures

Outcome Measure	Measure Description	Time Frame
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.	up to Day113
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.	up to Day113
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].	up to Day113
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.	up to Day113
Number of participants with abnormal clinically significant clinical laboratory results	Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.	up to Day113

Secondary Outcome Measures

Outcome Measure	Measure Description	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 baseline	To determine the immunogenicity of 9MW3811.	up to Day 113

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum interleukin-11 (IL-11) level after administration at specified timepoints relative to baseline	To explore the pharmacodynamics (PD) of 9MW3811.	up to Day 113

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): January 6, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pathological Conditions, Signs and Symptoms; Neoplasms; Pulmonary Fibrosis
• Other Study ID Numbers: 9MW3811-2022-CP101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No