Idiopathic Pulmonary FibrosisPhase 1NCT05912049
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Immunogenicity of 9MW3811 in Healthy Subjects
A Phase 1 study testing 9MW3811 Injection in people with Idiopathic Pulmonary Fibrosis, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a 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
- Idiopathic Pulmonary Fibrosis
- 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2023to Dec 2023
- 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 26.0 kg/m2, inclusive.
- In good health determined by the investigator based on a medical evaluation.
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, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody
- History of active tuberculosis, or participants with active or latent tuberculosis infection during screening
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215031
Liyan Miao, Professor, 0512-67972858, miaolysuzhou@163.com
About this study
Official title: A Phase 1, Randomized, Double-blind，Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Participants
This is a 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
- Idiopathic Pulmonary Fibrosis
- Being tested
- 9MW3811 Injection, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
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
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 Day113
Time to reach Cmax (Tmax)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day113
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 Day113
Terminal elimination half-life (t1/2)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day113
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 Day113
Terminal elimination rate constant (λz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day113
Apparent clearance (CL)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day113
Volume of distribution (Vz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Measured: up to Day113
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.
Measured: up to Day113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start26 Jul 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- 24 participants (estimated)
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
- NCT05912049
- Sponsor's protocol ID
- 9MW3811-2023-CP103
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind，Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of 9MW3811 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05912049
- Acronym / sponsor ID
- 9MW3811-2023-CP103
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jun 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 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 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 26.0 kg/m2, inclusive.
- In good health determined by the investigator based on a medical evaluation.
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.
9 secondary outcomes
Maximum Plasma Concentration (Cmax)
Time frame: up to Day113
Time to reach Cmax (Tmax)
Time frame: up to Day113
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: up to Day113
Terminal elimination half-life (t1/2)
Time frame: up to Day113
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: up to Day113
Terminal elimination rate constant (λz)
Time frame: up to Day113
Apparent clearance (CL)
Time frame: up to Day113
Volume of distribution (Vz)
Time frame: up to Day113
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
Time frame: up to Day113
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
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.
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 Idiopathic Pulmonary Fibrosis, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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). 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 1 Sep 2023.