A Phase 1 interventional study of 9MW3011 in Polycythemia Vera, sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. Recruiting at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Mabwell (Shanghai) Bioscience Co., Ltd. · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 9MW3011 in Chinese patients with Polycythemia Vera（PV）.
The multiple dose fo the starting dose cohorts will comprise 3 dose cohorts of 8 PV subjects each.In each cohort, subjects will receive 9MW3011 via intravenous infusion.A decision on whether to proceed with case expansion and dose escalation will be based on the safety and PK-PD data.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 108 is above the median of 52 across 204 interventional studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →Mabwell (Shanghai) Bioscience Co., Ltd. is the lead sponsor of 54 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion
Drug: 9MW3011
Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion
Drug: 9MW3011
Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion
Drug: 9MW3011
Multiple dose
Adverse Event
Incidence of adverse events
Time frame: Up to 141 or 197 days
Vital sign
Incidence of treatment-emergent clinically abnormal vital signs
Time frame: Up to 141 or 197 days
Physical examination
Incidence of treatment-emergent clinically abnormal physical examinations
Time frame: Up to 141 or 197 days
12-lead electrocardiogram (ECG)
Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)
Time frame: Up to 141 or 197 days
Laboratory test result
Incidence of treatment-emergent clinically significant laboratory test results
Time frame: Up to 141 or 197 days
Cmax
Plasma maximum measured drug concentration
Time frame: Day 1 to Day 141 or 197
Tmax
Time of maximum concentration
Time frame: Day 1 to Day 141 or 197
AUC0-τ
Area under the plasma concentration-time curve during a dosage interval（τ）
Time frame: Day 1 to Day 141 or 197
AUC0-t
Area under the concentration-time curve from dosing to the last measurable time point
Time frame: Day 1 to Day 141 or 197
AUC0-∞
Area under the concentration-time curve from dosing to infinity
Time frame: Day 1 to Day 141 or 197
λz
Terminal elimination rate constant
Time frame: Day 1 to Day 141 or 197
t1/2z
The terminal elimination half-life
Time frame: Day 1 to Day 141 or 197
MRT
Mean residence time
Time frame: Day 1 to Day 141 or 197
Vss
Volume of Distribution at Steady State
Time frame: Day 1 to Day 141 or 197
CLss
Steady-state clearance
Time frame: Day 1 to Day 141 or 197
DF
Fluctuation percentage
Time frame: Day 1 to Day 141 or 197
Ctrough
Trough Concentration
Time frame: Day 1 to Day 141 or 197
Rac(AUC)
Accumulation ratio calculated from the AUCτ,ss and AUCτ after single dosing
Time frame: Day 1 to Day 141 or 197
Rac(cmax)
Accumulation ratio calculated from the Cmax,ss and Cmax after single dosing
Time frame: Day 1 to Day 141 or 197
Hepcidin
Change from baseline in hepcidin levels
Time frame: Day 1 to Day 141 or 197
Serum iron
Change from baseline in serum iron levels
Time frame: Day 1 to Day 141 or 197
Transferrin saturation (TSAT)
Change from baseline in transferrin saturation (TSAT) levels
Time frame: Day 1 to Day 141 or 197
Anti-drug antibodies(ADA)
The incidence of ADA
Time frame: Day 1 to Day 141 or 197
Hematocrit (HCT)
Change from baseline in HCT levels
Time frame: Day1 to Day 141 or 197
Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score（MPN-SAF TSS）
Change from baseline in MPN-SAF TSS score
Time frame: Day 1 to Day 141 or 197
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Anti-TMPRSS6 Monoclonal Antibody DISC-3405
Mabwell (Shanghai) Bioscience Co., Ltd. →