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This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
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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 |
| 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 Day113 |
| Time to reach Cmax (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215031 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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 Day113 |
| 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 Day113 |
| Terminal elimination half-life (t1/2) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 |
| 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 Day113 |
| Terminal elimination rate constant (λz) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 |
| Apparent clearance (CL) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 |
| Volume of distribution (Vz) | To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants. | up to Day113 |
| Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline | To determine the immunogenicity of 9MW3811. | up to Day113 |