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

NCT06698861 | Completed Phase 1

• 1 other identifier: F23-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

immunomodulator

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of P2203 injection.

  The safety and tolerability of P2203 injection are evaluated by the occurrence of the adverse events, serious adverse events, and the abnormal clinical laboratory data, ECG changes, physical examination findings, and lab examinations.

  from day 1 to day 36

• To determine the maximum tolerated dose of P2203

  The maximum tolerated dose is defined as the highest tolerated dose level without the occurrence of predetermined unacceptable safety scenario during the 28-day safety monitoring period. Unacceptable safety scenario includes: * ≥ 1 of 6 subjects in Cohort 1 or ≥ 1 of 12 subjects in Cohort 2a experiences SAE(s) which is at least possibly related to P2203; * ≥ 2 of 6 subjects in Cohort 1 or ≥ 2 of 12 subjects in Cohort 2a have severe (Grade 3 or higher as per CTCAE) non-serious adverse events which is at least possibly related to P2203; * ≥ 2 of 6 subjects in Cohort 1 or ≥ 2 of 12 subjects in Cohort 2a have a drug related QTc pro-longation defined as QTcF \> 500 ms, or an increase of QTcF \> 60 ms above baseline on the 12-lead electrocardiogram (ECG), confirmed (persistent for \> 5 minutes) on repeated 12-lead ECGs; * The occurrence of significant safety events that may pose a risk to subjects as judged by the SRC review; any adverse event(s) leading to subject withdrawal must be judged b

  from Day 1 to Day 29

Study Arms (3)

Cohort 1: PEG-MetHuG-CSF 2 mg

EXPERIMENTAL

To evaluate the safety and tolerability of P2203. 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 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.

Drug: PEG-MetHuG-CSF

Cohort 2b: Neulasta 6 mg

ACTIVE COMPARATOR

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).

Drug: Neulasta (Amgen)

Cohort 2a: PEG-MetHuG-CSF 6 mg

EXPERIMENTAL

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).

Drug: PEG-MetHuG-CSF

Interventions

PEG-MetHuG-CSF DRUG

Single dose of PEG-MetHuG-CSF will be given SC injection at 2 mg in Cohort 1 and 6 mg in Cohort 2

Cohort 1: PEG-MetHuG-CSF 2 mg; Cohort 2a: PEG-MetHuG-CSF 6 mg

Neulasta (Amgen) DRUG

Single dose of Neulasta will be given SC injection at 6 mg in Cohort 2b.

Cohort 2b: Neulasta 6 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and voluntarily sign an informed consent form (ICF);
• Age ≥18 and ≤45 years of age at the time of informed consent;
• Subjects with a body weight ≥ 50 kg and with a body mass index (BMI) of ≥18.5 and \<30 kg/m2;
• Subjects who are non-smokers for at least 24 weeks preceding Screening;
• Males and females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use effective methods of contraception during the entire study period and for 12 weeks after dosing on Day 1; and females must agree to not breastfeed during the study;
• Subjects who are healthy as determined by pre-study medical his-tory, physical examination, and 12-lead ECG;
• Subjects whose clinical laboratory test results are within the refer-ence ranges for hematological parameters at Screening and admis-sion (Day -1 or Day 1 pre-dose). All other clinical laboratory test results must be within the reference range or judged not to be clini-cally significant and acceptable to the Investigator.

You may not qualify if:

• Clinically significant illness or surgery within 28 days prior to Dosing;
• Subjects have previously received G-CSF-related products;
• Donation of blood or any blood loss \> 500 mL in the last 12 weeks prior to Screening;
• Clinically significant vital sign abnormalities after ≥ 5 minutes supine or sitting rest, defined as any of the following values at Screening or admission (Day -1):
• systolic blood pressure \<90 or ≥ 140 mmHg; or
• diastolic blood pressure \<50 or ≥ 90 mmHg; or
• pulse rate \<50 or \>100 beats per minutes.
• Subjects who have any clinically important abnormalities in the 12-lead ECG at Screening as considered by the Investigators that may pose a risk to subjects or interfere with the interpretation of QTc interval changes;
• Subjects who have a prolonged QTcF \>450 ms at Screening or family history of long QT syndrome;
• Subjects with history of drug or alcohol abuse; or those with positive result in the drug or ethanol examination at Screening or admission (Day -1);
• Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody at Screening;
• Subjects with latex hypersensitivity or those have a history of severe allergy and/or severe drug reaction (e.g., anaphylaxis, other drug reaction requiring hospitalization, OR any other drug hypersensitivity); or those have known allergic reactions to any component of the treatments in this study;
• Immunization with a live attenuated vaccine during a 28-day period prior to dosing, immunization with an inactivated or mRNA vaccine during a 14-day period prior to dosing, or planned immunization of any kind of vaccine during the course of the study;
• Subjects with syphilis or those have a clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection, or unexplained cause of clinically significant inflammatory, within the 28 days prior to Dosing, e.g., common cold, viral syndrome, flu-like symptoms, etc;
• Subjects who have acute gastrointestinal symptoms at Screening or admission (Day -1) (e.g., nausea, vomiting, diarrhea, and heartburn);

Sponsors & Collaborators

• PharmaEssentia: lead
• Novotech CRO: collaborator

Study Sites (1)

Mackay Memorial Hospital, Taipei, Taiwan

Taipei, Taiwan, 251020, Taiwan

Location

MeSH Terms

Interventions

pegfilgrastim

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 21, 2024
• Study Start: August 19, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

TW (1)