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

NCT05740475 | Completed Phase 1

• 1 other identifier: 9MW3811-2022-CP101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis; Tumor

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (9)

• Maximum Plasma Concentration (Cmax)

  up to Day 113

• Time to reach Cmax (Tmax)

  up to Day 113

• Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)

  up to Day 113

• Terminal elimination half-life (t1/2)

  up to Day 113

• AUC from time 0 extrapolated to infinity (AUC0-inf)

  up to Day 113

Other Outcomes (1)

• Serum interleukin-11 (IL-11) level after administration at specified timepoints relative to baseline

  up to Day 113

Study Arms (2)

9MW3811 injection

EXPERIMENTAL

single dose escalation for experimental drug

Drug: 9MW3811 injection

placebo

PLACEBO COMPARATOR

matching placebo administration for control

Drug: Placebo

Interventions

9MW3811 injection DRUG

Single dose intravenously infused on day 1

9MW3811 injection

Placebo DRUG

Single dose of matching placebo intravenously infused on day 1

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Scientia Clinical Research

Randwick, New South Wales, Australia

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 23, 2023
• Study Start: March 20, 2023
• Primary Completion: September 14, 2023
• Study Completion: January 6, 2024
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)