Clinical trial · Interventional
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
NCT00097747CI-TRIAL-00008725completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Kidney Disease | — | UNRESOLVED | — |
| Chronic Renal Failure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| peginesatide | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Single injection administered intravenously
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Peginesatide 0.025 mg/kg
- description
- Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.
- interventionNames
- Drug: peginesatide
- type
- EXPERIMENTAL
- label
- Peginesatide 0.05 mg/kg
- description
- Single peginesatide dose of 0.05 mg/kg administered intravenously.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Main eligibility criteria: * Participant is a healthy male, age ≥ 18 years and ≤ 40 years, with body mass index (BMI) ≥ 18 and ≤ 30 kilograms per squared meter (kg/m\^2), and weight ≥ 50 and ≤ 95 kilograms (kg) * Participant has hemoglobin of ≤ 16 grams per deciliter (g/dL) at the time of study entry * Participant has normal iron stores
References
Publications (0)
Data not yet available
No reference posted for this study.