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This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
The single ascending dose study will comprise 4 dose cohorts of 8 healthy participants each. In each cohort, participants will be randomized to receive 9MW3811 or placebo by 6:2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW3811 injection | Experimental | single dose escalation for experimental drug |
|
| placebo | Placebo Comparator | matching placebo administration for control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW3811 injection | Drug | Single dose intravenously infused on day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) as assessed by CTCAE v5.0 | An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | up to Day113 |
| Number of participants with abnormal clinically significant results from physical examination | The physical examinations will include examination of the following: head, eyes, ears, nose and throat, neck (including thyroid & nodes), cardiovascular system, dermatological system, musculoskeletal system, respiratory system, gastrointestinal system, neurological system and renal system. | up to Day113 |
| Number of participants 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, QTcF = QT/(RR^0.33), RR is the standardized heart rate value, which is obtained by dividing 60 by the heart rate]. | up to Day113 |
| Number of participants with abnormally clinical vital signs | Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature. | up to Day113 |
| Number of participants with abnormal clinically significant clinical laboratory results | Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function. | up to Day113 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| Time to reach Cmax (Tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum interleukin-11 (IL-11) level after administration at specified timepoints relative to baseline | To explore the pharmacodynamics (PD) of 9MW3811. | up to Day 113 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research | Randwick | New South Wales | Australia |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| Placebo |
| Drug |
Single dose of matching placebo intravenously infused on day 1 |
|
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
| up to Day 113 |
| Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| Terminal elimination half-life (t1/2) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| AUC from time 0 extrapolated to infinity (AUC0-inf) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| Terminal elimination rate constant (λz) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| Apparent clearance (CL) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| Volume of distribution (Vz) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day 113 |
| Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline | To determine the immunogenicity of 9MW3811. | up to Day 113 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |