Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001655-11 | EudraCT Number |
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
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.
This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Single injection administered intravenously |
|
| Peginesatide 0.025 mg/kg | Experimental | Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously. |
|
| Peginesatide 0.05 mg/kg | Experimental | Single peginesatide dose of 0.05 mg/kg administered intravenously. |
|
| Peginesatide 0.10 mg/kg | Experimental | Single peginesatide dose of 0.10 mg/kg administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| peginesatide |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters | 28 Days | |
| Pharmacodynamic (PD) parameters | 28 Days |
Not provided
Main eligibility criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Affymax | Affymax, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | London | HA1 3UJ | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C556270 | peginesatide |
| C514771 | hematide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |