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drugset / Trial / NCT06698861

A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers

NCT06698861 ↗

Phase 1 Completed 30 enrolled PharmaEssentia Novotech CRO · collab
RandomizedSequentialOpen-labelTreatment

Summary

The goal of this study type: PK clinical trial is to evaluate the safety, tolerability, and pharmacokinetics/ pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers. Primary objective: ‧ To evaluate the safety and tolerability of P2203 Secondary objectives: ‧ To characterize the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of P2203 Approximately 30 healthy volunteers will be enrolled. Subjects will be screened within 28 days before study dosing. Eligible subjects will be sequentially enrolled into 2 escalating-dose cohorts (Cohort 1 and 2) to receive a single dose of P2203 at a pre-determined specific dose or to re-ceive a single dose of 6 mg pegfilgrastim (Neulasta).

Timeline

Start
2024-08-19
Primary completion
2025-02-06
Completion
2025-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG-MetHuG-CSF Unknown 2 mg Subcutaneous
Subject PEG-MetHuG-CSF Unknown 6 mg Subcutaneous
Comparator Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications

No indication recorded.