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

NCT06698861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-29

No results posted yet for this study

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).

Conditions

  • PK in Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Novotech CRO

    collaborator UNKNOWN

  • PharmaEssentia

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698861 on ClinicalTrials.gov