Pulmonary FibrosisPhase 1NCT05740475
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
A Phase 1 study testing 9MW3811 injection in people with Pulmonary Fibrosis and Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis, Tumor
- What is being tested?
- 9MW3811 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Mar 2023to 6 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Fibrosis, Tumor
- Being tested
- 9MW3811 injection, Placebo
- Medical subject headings
- Pulmonary Fibrosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW3811 injectionDrug
Single dose intravenously infused on day 1
PlaceboDrug
Single dose of matching placebo intravenously infused on day 1
| Study group | Role | What they receive |
|---|---|---|
| 9MW3811 injection | Experimental | single dose escalation for experimental drug Receives: Drug: 9MW3811 injection |
| placebo | Placebo comparator | matching placebo administration for control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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].
Measured: 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.
Measured: up to Day113
Number of participants with abnormal clinically significant clinical laboratory results
Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.
Measured: up to Day113
Secondary outcomes (9)
Maximum Plasma Concentration (Cmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day 113
Time to reach Cmax (Tmax)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to Day 113
Terminal elimination rate constant (λz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day 113
Apparent clearance (CL)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day 113
Volume of distribution (Vz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day 113
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.
Measured: up to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start20 Mar 2023
- Primary completion14 Sep 2023
- Study completion6 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740475
- Sponsor's protocol ID
- 9MW3811-2022-CP101
- Status last verified
- Dec 2025
- First submitted
- 2 Feb 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05740475
- Acronym / sponsor ID
- 9MW3811-2022-CP101
- Conditions
- Pulmonary Fibrosis, Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9MW3811 injection | Experimental | Drug: 9MW3811 injectionsingle dose escalation for experimental drug |
| placebo | Placebo comparator | Drug: Placebomatching placebo administration for control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9MW3811 injectionSingle dose intravenously infused on day 1 | Drug | 9MW3811 injection |
| PlaceboSingle dose of matching placebo intravenously infused on day 1 | Drug | placebo |
Primary outcome
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
Time frame: up to Day113
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
Time frame: up to Day113
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
Time frame: up to Day113
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
Time frame: up to Day113
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
Time frame: up to Day113
Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.
9 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: up to Day 113
Time to reach Cmax (Tmax)
Time frame: up to Day 113
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: up to Day 113
Terminal elimination half-life (t1/2)
Time frame: up to Day 113
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: up to Day 113
Terminal elimination rate constant (λz)
Time frame: up to Day 113
Apparent clearance (CL)
Time frame: up to Day 113
Volume of distribution (Vz)
Time frame: up to Day 113
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
Time frame: up to Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 9MW3811 injection in people with Pulmonary Fibrosis and Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) as assessed by CTCAE v5.0 (time frame: up to Day113). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.