Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects
A Single-blind, Randomized, and Placebo-Controlled Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 by Intravenous Single Dose Escalation(SAD) and Repeated Doses(RD) in Healthy Subjects. A SAD portion of the study consists of 2 sequential dose escalation cohorts, whereas RD portion of the study consists of a single cohort receiving 4 weekly doses of 3D229. In both SAD and RD study arms, subjects are randomized to receive either a study intervention (3D229) or matching placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Escalation-3D229 | Experimental | two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo |
|
| Single Dose Escalation- placebo | Placebo Comparator | two sequential dose escalation cohorts - patients are randomized either to investigational drug or matching placebo |
|
| Repeat Dose-3D229 | Experimental | Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo |
|
| Repeat Dose-placebo | Placebo Comparator | Four single doses of the investigational drug or matching placebo - patients are randomized either to investigational drug or matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D229 | Drug | 3D229 is an investigational drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 3D229-Adverse events | Monitoring of adverse events | Up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the curve | Up to 7 weeks |
| Cmax | Maximum observed concentration | Up to 7 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| xueying ding | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General hospital | Shanghai | Hongkou District | 201321 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Matching placebo |
|
| Ctrough | Serum concentration observed at end of a single dose and observed pre-dose during repeat doses | Up to 7 weeks |
| Tmax | Time to reach maximum observed plasma concentration | Up to 7 weeks |
| λz | Terminal phase elimination rate constant | Up to 7 weeks |
| t1/2 | Terminal half-life | Up to 3 weeks |
| CL | The total body clearance | Up to 7 weeks |
| V | Volume of distribution | Up to 7 weeks |
| serum GAS6 | evaluate the serum GAS6 level | Up to 7 weeks |