New drug 9MW1911 tested for safety in first human trial
NCT ID NCT05803902
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 1 trial tested the safety and tolerability of a new drug called 9MW1911 in 48 healthy adults. The drug is being developed for asthma, COPD, and atopic dermatitis. Participants received either the drug or a placebo by IV infusion, and researchers monitored side effects and how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 9MW1911 injection
- What this could lead to
- If successful, this could lead to a new treatment option for asthma, COPD, or atopic dermatitis.
- What could go wrong
- This is a very early Phase 1 trial in healthy people, not patients. It only checks safety and dosing, not whether the drug works for the diseases. Many drugs fail in later stages.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
48 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Mar 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 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. Exclusion Criteria: * 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Peking Union Hospital
Beijing, Beijing Municipality, 100000, China
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