HealthyPhase 1NCT06389942
Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject
A Phase 1 study testing 9MW3011 in people with Healthy, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 9MW3011
- 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
- 10 Mar 2023to 31 May 2024
- 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
- 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).
- Being judged by the investigator to be eligible based on medical history, physical examination, laboratory tests and test related items of inspection or no clinically significant mild abnormalities.
- Volunteered to participate in this clinical trial, capable of giving written informed consent.
Who cannot join
- Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system , immune system, urinary system diseases , or a family history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, etc.), may affect the health status of the subjects or any other diseases and physiological conditions that may affect the results of the study , judged by the investigator.
- Currently suffering from iron deficiency/Iron deficiency anemia, taking iron supplements and complicated with other diseases related to abnormal iron metabolism.
- Subjects who have a history of allergies to monoclonal antibodies or any drug components; those who have a history of allergies to excipients of 9MW3011.
- Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.
- Positive for hepatitis B virus surface antigen and/or hepatitis B virus e antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.
- 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 Single-center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Characteristics of 9MW3011 in Healthy Volunteers
The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers.
Read the detailed description
The single ascending dose(SAD) study will comprise 6 dose cohorts of 8 healthy volunteers each. In each cohort, subjects will be randomized in a 6:2 ratio to receive 9MW3011 or placebo via intravenous infusion.
- Conditions
- Healthy
- Being tested
- 9MW3011, 9MW3011 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW3011Drug
Single dose intravenously on day 1
9MW3011 placeboDrug
Single dose intravenously on day 1
| Study group | Role | What they receive |
|---|---|---|
| 9MW3011 Dose 1 | Experimental | Ascending IV doses administered per protocol Receives: Drug: 9MW3011; Drug: 9MW3011 placebo |
| 9MW3011 Dose 2 | Experimental | Ascending IV doses administered per protocol Receives: Drug: 9MW3011; Drug: 9MW3011 placebo |
| 9MW3011 Dose 3 | Experimental | Ascending IV doses administered per protocol Receives: Drug: 9MW3011; Drug: 9MW3011 placebo |
| 9MW3011 Dose 4 | Experimental | Ascending IV doses administered per protocol Receives: Drug: 9MW3011; Drug: 9MW3011 placebo |
| 9MW3011 Dose 5 | Experimental | Ascending IV doses administered per protocol Receives: Drug: 9MW3011; Drug: 9MW3011 placebo |
| 9MW3011 Dose 6 | Experimental | Ascending IV doses administered per protocol Receives: Drug: 9MW3011; Drug: 9MW3011 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 and SAEs from treatment until the last scheduled follow-up visit
Measured: up to day 99
Secondary outcomes (17)
Number of subjects with abnormal vital signs
Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.
Measured: up to day 99
Number of subjects with abnormal clinically significant results from physical examination
The physical examinations will include examination of the following: skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal, nervous system, and other sites of note elicited from the subject.
Measured: up to day 99
Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula).
Measured: up to day 99
Number of subjects with abnormal clinically significant clinical laboratory results
Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.
Measured: up to day 99
Cmax
The peak concentration
Measured: up to day 85
AUC0-t
The area under the concentration-time curve from zero to the last time point
Measured: up to day 85
AUC0-∞
The area under the concentration-time curve from zero to infinity
Measured: up to day 85
Tmax
The time to reach peak concentration
Measured: up to day 85
λz
Terminal elimination rate constant
Measured: up to day 85
t1/2z
The terminal elimination half-life
Measured: up to day 85
Vz
The volume of distribution
Measured: up to day 85
CL
Clearance
Measured: up to day 85
MRT
Mean residence time
Measured: up to day 85
Pharmacodynamic(PD)parameters-hepcidin
Change from baseline in hepcidin levels
Measured: up to day 85
PD parameters-serum iron
Change from baseline in serum iron levels
Measured: up to day 85
PD parameters-TSAT
Change from baseline in transferrin saturation(TSAT) levels
Measured: up to day 85
Anti-drug antibodies(ADA)
The incidence of ADA
Measured: up to day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start10 Mar 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT06389942
- Sponsor's protocol ID
- 9MW3011-2022-CP101
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Characteristics of 9MW3011 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06389942
- Acronym / sponsor ID
- 9MW3011-2022-CP101
- Conditions
- Healthy
- 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
- 10 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Apr 2024 (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.
The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers.
Detailed description
The single ascending dose(SAD) study will comprise 6 dose cohorts of 8 healthy volunteers each. In each cohort, subjects will be randomized in a 6:2 ratio to receive 9MW3011 or placebo via intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 9MW3011 Dose 1 | Experimental | Drug: 9MW3011, Drug: 9MW3011 placeboAscending IV doses administered per protocol |
| 9MW3011 Dose 2 | Experimental | Drug: 9MW3011, Drug: 9MW3011 placeboAscending IV doses administered per protocol |
| 9MW3011 Dose 3 | Experimental | Drug: 9MW3011, Drug: 9MW3011 placeboAscending IV doses administered per protocol |
| 9MW3011 Dose 4 | Experimental | Drug: 9MW3011, Drug: 9MW3011 placeboAscending IV doses administered per protocol |
| 9MW3011 Dose 5 | Experimental | Drug: 9MW3011, Drug: 9MW3011 placeboAscending IV doses administered per protocol |
| 9MW3011 Dose 6 | Experimental | Drug: 9MW3011, Drug: 9MW3011 placeboAscending IV doses administered per protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- Being judged by the investigator to be eligible based on medical history, physical examination, laboratory tests and test related items of inspection or no clinically significant mild abnormalities.
- Volunteered to participate in this clinical trial, capable of giving written informed consent.
Key exclusion criteria (6 listed)
- Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system , immune system, urinary system diseases , or a family history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, etc.), may affect the health status of the subjects or any other diseases and physiological conditions that may affect the results of the study , judged by the investigator.
- Currently suffering from iron deficiency/Iron deficiency anemia, taking iron supplements and complicated with other diseases related to abnormal iron metabolism.
- Subjects who have a history of allergies to monoclonal antibodies or any drug components; those who have a history of allergies to excipients of 9MW3011.
- Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.
- Positive for hepatitis B virus surface antigen and/or hepatitis B virus e antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.
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 |
|---|---|---|
| 9MW3011Single dose intravenously on day 1 | Drug | 9MW3011 Dose 1, 9MW3011 Dose 2, 9MW3011 Dose 3, 9MW3011 Dose 4, 9MW3011 Dose 5, 9MW3011 Dose 6 |
| 9MW3011 placeboSingle dose intravenously on day 1 | Drug | 9MW3011 Dose 1, 9MW3011 Dose 2, 9MW3011 Dose 3, 9MW3011 Dose 4, 9MW3011 Dose 5, 9MW3011 Dose 6 |
Primary outcome
Adverse Event(including serious adverse event)
Time frame: up to day 99
The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit
17 secondary outcomes
Number of subjects with abnormal vital signs
Time frame: up to day 99
Number of subjects with abnormal clinically significant results from physical examination
Time frame: up to day 99
Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time frame: up to day 99
Number of subjects with abnormal clinically significant clinical laboratory results
Time frame: up to day 99
Cmax
Time frame: up to day 85
AUC0-t
Time frame: up to day 85
AUC0-∞
Time frame: up to day 85
Tmax
Time frame: up to day 85
λz
Time frame: up to day 85
t1/2z
Time frame: up to day 85
Vz
Time frame: up to day 85
CL
Time frame: up to day 85
MRT
Time frame: up to day 85
Pharmacodynamic(PD)parameters-hepcidin
Time frame: up to day 85
PD parameters-serum iron
Time frame: up to day 85
PD parameters-TSAT
Time frame: up to day 85
Anti-drug antibodies(ADA)
Time frame: up to day 85
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 27 Dec 2024.
- 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.
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 9MW3011 in people with Healthy, 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 6 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 27 Dec 2024. 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: up to day 99). 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 27 Dec 2024.