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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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.

China1 site

Peking Union Hospital
Beijing, Beijing Municipality, 100000

Other trials in China

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 groups in NCT05803902
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.

15 Dec 20216 Mar 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

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

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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?

On the ClinicalTrials.gov record for NCT05803902.

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.