NCT06698861

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

A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed description

Subjects will be sequentially enrolled into the following inter-subject dose escalation cohorts: * Cohort 1 (6 subjects): single dose of P2203 at 2 mg * Cohort 2 (24 subjects): subjects in Cohort 2 will be randomized in a 1:1 ratio to receive a single dose of 6 mg P2203 (Cohort 2a, 12 sub-jects) or a single dose of 6 mg pegfilgrastim (Cohort 2b, 12 subjects). In Cohort 1, the first two subjects will be the sentinel subjects treated with staggered dosing. The 1st sentinel subject of Cohort 1 will be dosed at least 96 hours prior to the 2nd sentinel subject. The 2nd sentinel subject will receive P2203 when the Criteria for Dosing Suspension or Termination in a Given Dose Cohort (Section 3.5) is not met at least during the first 96 hours following administration of P2203 of the 1st sentinel subject. The remaining subject in Cohort 1 will receive P2203 when the Criteria for Dosing Suspension or Termination in a Given Dose Cohort is not met at least during the first 96 hours following administration of P2203 of the 2nd sentinel subject. In Cohort 2a, the first three subjects will be the sentinel subjects treated with staggered dosing. The rule and time interval for the stagger dosing in the sentinel subjects in Cohort 2a are the same as those in Cohort 1. In Cohort 2, subjects will be randomized in a 1:1 ratio to receive a single dose of 6 mg P2203 (Cohort 2a, 12 subjects) or a single dose of 6 mg pegfilgrastim (Cohort 2b, 12 subjects).

Conditions

• PK in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	PEG-MetHuG-CSF	Single dose of PEG-MetHuG-CSF will be given SC injection at 2 mg in Cohort 1 and 6 mg in Cohort 2
DRUG	Neulasta (Amgen)	Single dose of Neulasta will be given SC injection at 6 mg in Cohort 2b.

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2024-11-21
• Last updated: 2025-06-29

Locations

1 site across 1 country: Taiwan