AsthmaPhase 1NCT05170243
A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection
A Phase 1 study testing 9MW1911 Injection in people with Asthma and COPD, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, COPD, Atopic Dermatitis
- What is being tested?
- 9MW1911 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2022to 28 Oct 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are willing to follow study procedures and sign informed consent voluntarily.
- Male or female subjects aged 18 to 65 years (including 18 and 65 years).
- Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value).
- Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily;Subjects have neither pregnancy plans nor sperm or egg donation plans during the screening period and the next 6 months.
Who cannot join
- Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
- The clinical laboratory tests show any clinical abnormalities, or abnormalities with clinical significance(including but not limited to diseases of digestive tract, kidney, liver, nervous system, blood, endocrine system, cancer, lung, immune system, mental, heart),and judged by the investigator to affect participation in this study.
- Subjects with prolonged QTcF interval (> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.
- Subjects (female) who is pregnant or lactating at screening or during the trial.
- Subjects who have previously used immunosuppressants or monoclonal antibodies for any reason.
- Subjects who used any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
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- Subjects who received any vaccinations within 4 weeks prior to screening, or are scheduled to receive a vaccination during the study.
- Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study.
- Subjects who have a history of drug abuse within 6 months prior to screening.
- Subjects who have used illicit drugs within 3 months prior to screening.
- Subjects who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the study.
- Subjects who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot abstain from cigarette product during the study.
- Subjects who have participated in drug or medical devices clinical trials within 3 months prior to screening.
- Subjects who donated or lost blood ≥ 200 mL within 3 months prior to screening, or plan to donate blood within 3 months.
- Subjects whose alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]).
- Subjects who have one or more clinically significant tests of hepatitis B virological markers, hepatitis C virus antibodies, anti-human immunodeficiency virus antibodies, or anti-Treponema pallidum-specific antibodies.
- Subjects who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
- Subjects who show insufficient communication, understanding and cooperation, or poor compliance to ensure observation and follow-up as required by the protocol.
- Subjects with abnormal vital signs with clinical significance: diastolic blood pressure≤50 mmHg or ≥90 mmHg, pulse≤50 beats/min or ≥100 beats/min, body temperature (ear temperature) <35.5°C or >37.5°C, respiration>20 breaths/min. The specific situation will be comprehensively determined by the investigator.
- Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Center
Shanghai, Shanghai Municipality, 200540
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Immunogenicity of a Single Dose of 9MW1911 Injection in Healthy Subjects
This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers. All subjects will be followed up for safety from the time of Informed Consent through 113 days post dose.
- Conditions
- Asthma, COPD, Atopic Dermatitis
- Being tested
- 9MW1911 Injection, 9MW1911 Injection Placebo
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW1911 InjectionDrug
Single dose intravenously on day 1
9MW1911 Injection PlaceboDrug
Single dose of matching placebo intravenously on day 1
| Study group | Role | What they receive |
|---|---|---|
| 9MW1911 Injection | Active comparator | Experimental drug administered IV infusion Receives: Drug: 9MW1911 Injection |
| 9MW1911 Injection Placebo | Placebo comparator | Placebo administered IV infusion Receives: Drug: 9MW1911 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event(including serious adverse event)
The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit
Measured: up to day 113
Secondary outcomes (5)
PK parameters
Maximum concentration(Cmax)
Measured: up to day 113
PK parameters
The area under the curve (AUC)
Measured: up to day 113
PK parameters
Time at which maximum concentration(Tmax)
Measured: up to day 113
PK parameters
The half life(T1/2)
Measured: up to day 113
Incidence of ADAs Against 9MW1911
The incidence of ADAs against 9MW1911 during the study will be summarized
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 posted27 Dec 2021
- Study start21 Jan 2022
- Primary completion3 Jul 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang Shuhai, Ph.D, Study chair, Mabwell (Shanghai) Bioscience Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170243
- Sponsor's protocol ID
- 9MW1911-2021-CP102
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2021
- Last updated
- 11 Dec 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Immunogenicity of a Single Dose of 9MW1911 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05170243
- Acronym / sponsor ID
- 9MW1911-2021-CP102
- Conditions
- Asthma, COPD, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 3 Jul 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 27 Dec 2021 (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 Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers. All subjects will be followed up for safety from the time of Informed Consent through 113 days post dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 9MW1911 Injection | Active comparator | Drug: 9MW1911 InjectionExperimental drug administered IV infusion |
| 9MW1911 Injection Placebo | Placebo comparator | Drug: 9MW1911 Injection PlaceboPlacebo administered IV infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants are willing to follow study procedures and sign informed consent voluntarily.
- Male or female subjects aged 18 to 65 years (including 18 and 65 years).
- Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value).
- Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily;Subjects have neither pregnancy plans nor sperm or egg donation plans during the screening period and the next 6 months.
Key exclusion criteria (20 listed)
- Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
- The clinical laboratory tests show any clinical abnormalities, or abnormalities with clinical significance(including but not limited to diseases of digestive tract, kidney, liver, nervous system, blood, endocrine system, cancer, lung, immune system, mental, heart),and judged by the investigator to affect participation in this study.
- Subjects with prolonged QTcF interval (> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.
- Subjects (female) who is pregnant or lactating at screening or during the trial.
- Subjects who have previously used immunosuppressants or monoclonal antibodies for any reason.
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 |
|---|---|---|
| 9MW1911 InjectionSingle dose intravenously on day 1 | Drug | 9MW1911 Injection |
| 9MW1911 Injection PlaceboSingle dose of matching placebo intravenously on day 1 | Drug | 9MW1911 Injection Placebo |
Primary outcome
Adverse Event(including serious adverse event)
Time frame: up to day 113
The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit
5 secondary outcomes
PK parameters
Time frame: up to day 113
PK parameters
Time frame: up to day 113
PK parameters
Time frame: up to day 113
PK parameters
Time frame: up to day 113
Incidence of ADAs Against 9MW1911
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 11 Dec 2023.
- 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.
Wang Shuhai, Ph.D study chair
Mabwell (Shanghai) Bioscience Co., Ltd.
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 9MW1911 Injection in people with Asthma and COPD, 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 4 inclusion and 20 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 11 Dec 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?
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?
Adverse Event(including serious adverse event) (time frame: up to day 113). 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 11 Dec 2023.