AsthmaPhase 1NCT05803902
An Evaluation of 9MW1911 Injection in Healthy Subjects
A Phase 1 study testing Experimental drug 9MW1911 in people with Asthma and COPD, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects. 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?
- Experimental drug 9MW1911
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2021to 6 Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Male or female subjects aged 18 to 65 years (including 18 and 65 years). 2. 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).
- 3. Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily.
Who cannot join
- 1. 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.
- 2. 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.
- 3. Subjects with prolonged QTcF interval (> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.
- 4. Subjects received any biological treatment (including all vaccines except the coronavirus vaccine) within 3 months before screening, or planned to take biological treatment during the study period, or received the new coronavirus vaccine within 1 month before screening.
- 5. Subjects received any prescription drugs or traditional Chinese medicines, including vitamins, trace elements or dietary supplements within 14 days before screening; except for topical products without systemic absorption.
- 6. Subjects with a history of smoking within 6 months before screening, or unwilling to stop smoking during the study, or willing to use products containing nicotine during the study.
Show all 10Show fewer
- 7. Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.
- 8. Subjects positive screening for viral hepatitis (including hepatitis B and C), HIV antibodies, and Treponema pallidum antibodies.
- 9. Subjects who paticipated any clinical trial within 3 months before screening.
- 10. 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.
About this study
Official title: A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 9MW1911 Injection in Healthy Subjects
This study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects.
- Conditions
- Asthma, COPD, Atopic Dermatitis
- Being tested
- Experimental drug 9MW1911, 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.
Experimental drug 9MW1911Drug
Experimental drug administered with IV infusion
PlaceboDrug
Placebo administered with IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 9MW1911 Dose 1 | Experimental | 9MW1911 injection ( Dose 1) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 2 | Experimental | 9MW1911 injection (Dose 2) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 3 | Experimental | 9MW1911 injection (Dose 3) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 4 | Experimental | 9MW1911 injection (Dose 4) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 5 | Experimental | 9MW1911 injection (Dose 5) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 6 | Experimental | 9MW1911 injection (Dose 6) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 7 | Experimental | 9MW1911 injection (Dose 7) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
| 9MW1911 Dose 8 | Experimental | 9MW1911 injection (Dose 8) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. Receives: Drug: Experimental drug 9MW1911; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event(including serious adverse event)
Evaluate the safety and tolerability of 9MW1911 in healthy subjects, and to determine the possible maximum tolerated dose (MTD).
Measured: Day0-Day113
Secondary outcomes (5)
Pharmacokinetics parameters
Maximum concentration(Cmax)
Measured: Day0-Day113
Pharmacokinetics parameters
The area under the curve (AUC)
Measured: Day0-Day113
Pharmacokinetics parameters
Time at which maximum concentration(Tmax)
Measured: Day0-Day113
Pharmacokinetics parameters
The half life(T1/2)
Measured: Day0-Day113
Immunogenicity parameters
The incidence of ADAs against 9MW1911 during the study will be summarized
Measured: Day0-Day113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start15 Dec 2021
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT05803902
- Sponsor's protocol ID
- 9MW1911-2021-CP101
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 9MW1911 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05803902
- Acronym / sponsor ID
- 9MW1911-2021-CP101
- Conditions
- Asthma, COPD, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 7 Apr 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 study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 9MW1911 Dose 1 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection ( Dose 1) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 2 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 2) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 3 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 3) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 4 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 4) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 5 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 5) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 6 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 6) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 7 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 7) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
| 9MW1911 Dose 8 | Experimental | Drug: Experimental drug 9MW1911, Drug: Placebo9MW1911 injection (Dose 8) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Male or female subjects aged 18 to 65 years (including 18 and 65 years). 2. 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).
- 3. Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily.
Key exclusion criteria (10 listed)
- 1. 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.
- 2. 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.
- 3. Subjects with prolonged QTcF interval (> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.
- 4. Subjects received any biological treatment (including all vaccines except the coronavirus vaccine) within 3 months before screening, or planned to take biological treatment during the study period, or received the new coronavirus vaccine within 1 month before screening.
- 5. Subjects received any prescription drugs or traditional Chinese medicines, including vitamins, trace elements or dietary supplements within 14 days before screening; except for topical products without systemic absorption.
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 |
|---|---|---|
| Experimental drug 9MW1911Experimental drug administered with IV infusion | Drug | 9MW1911 Dose 1, 9MW1911 Dose 2, 9MW1911 Dose 3, 9MW1911 Dose 4, 9MW1911 Dose 5, 9MW1911 Dose 6, 9MW1911 Dose 7, 9MW1911 Dose 8 |
| PlaceboPlacebo administered with IV infusion | Drug | 9MW1911 Dose 1, 9MW1911 Dose 2, 9MW1911 Dose 3, 9MW1911 Dose 4, 9MW1911 Dose 5, 9MW1911 Dose 6, 9MW1911 Dose 7, 9MW1911 Dose 8 |
Primary outcome
Adverse Event(including serious adverse event)
Time frame: Day0-Day113
Evaluate the safety and tolerability of 9MW1911 in healthy subjects, and to determine the possible maximum tolerated dose (MTD).
5 secondary outcomes
Pharmacokinetics parameters
Time frame: Day0-Day113
Pharmacokinetics parameters
Time frame: Day0-Day113
Pharmacokinetics parameters
Time frame: Day0-Day113
Pharmacokinetics parameters
Time frame: Day0-Day113
Immunogenicity parameters
Time frame: Day0-Day113
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 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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 Experimental drug 9MW1911 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 2 inclusion and 10 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 15 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 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. 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: Day0-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 15 Dec 2025.