PK in Healthy VolunteersPhase 1P2203 phase INCT06698861

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

A Phase 1 study testing PEG-MetHuG-CSF and Neulasta (Amgen) in people with PK in Healthy Volunteers, run by PharmaEssentia at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: PK in Healthy Volunteers
What is being tested?: PEG-MetHuG-CSF and Neulasta (Amgen)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteTaiwan
Study dates: 19 Aug 2024to 6 Feb 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 24Show fewer

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);
Take any prescription drugs within 14 days or nonprescription drugs (except routine vitamins at the recommended daily dose) within 7 days prior to Dosing were not allowed unless specified in the protocol or agreed as not clinically relevant by the Principal Investigator;
History of body organ transplant and are taking immunosuppressants at Screening; subject with history of bone marrow/hematopoietic stem cell transplantation, regardless of whether s/he is taking immunosuppressants at Screening, will be excluded;
Subjects who have received other investigational product within the last 12 weeks or within 5 times the half-life prior to Screening, whichever is longer;
Subjects who have received drugs containing lithium, systemic immunosuppressants, e.g., corticosteroid, or herbal remedies within 28 days prior to screening;
Subjects who have consumed grapefruit, grapefruit juice or other products containing grapefruit within 7 days prior to Dosing;
History of any malignant disease, including solid tumor and hematologic malignancies;
Pregnant subjects;
Subjects who are unlikely to co-operate with the requirements of the study;
Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Mackay Memorial Hospital, Taipei, Taiwan
Taipei, Taiwan, 251020

Other trials in Taiwan

About this study

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

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).

Read the 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
Being tested: PEG-MetHuG-CSF, Neulasta (Amgen)
Keywords: immunomodulator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06698861
Study group	Role	What they receive
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. Receives: 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). Receives: 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). Receives: Drug: PEG-MetHuG-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: from Day 1 to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 20246 Feb 2025

First posted21 Nov 2024
Study start19 Aug 2024
Primary completion6 Feb 2025
Study completion6 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PK in Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06698861
Sponsor's protocol ID: F23-101
Acronym: P2203 phase I
Status last verified: Jun 2025
First submitted: 28 Oct 2024
Last updated: 29 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
ClinicalTrials.gov ID: NCT06698861
Acronym / sponsor ID: P2203 phase I / F23-101
Conditions: PK in Healthy Volunteers
Keywords: immunomodulator
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PharmaEssentiaIndustry (pharma, biotech, devices)
Collaborators: Novotech CRO
Study start: 19 Aug 2024 (actual)
Primary completion: 6 Feb 2025 (actual)
Study completion: 6 Feb 2025 (actual)
First posted: 21 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1: PEG-MetHuG-CSF 2 mg	Experimental	Drug: PEG-MetHuG-CSFTo 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.
Cohort 2b: Neulasta 6 mg	Active comparator	Drug: Neulasta (Amgen)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).
Cohort 2a: PEG-MetHuG-CSF 6 mg	Experimental	Drug: PEG-MetHuG-CSFIn 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).

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (24 listed)

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):
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PEG-MetHuG-CSFSingle dose of PEG-MetHuG-CSF will be given SC injection at 2 mg in Cohort 1 and 6 mg in Cohort 2	Drug	Cohort 1: PEG-MetHuG-CSF 2 mg, Cohort 2a: PEG-MetHuG-CSF 6 mg
Neulasta (Amgen)Single dose of Neulasta will be given SC injection at 6 mg in Cohort 2b.	Drug	Cohort 2b: Neulasta 6 mg

Primary outcome

To evaluate the safety and tolerability of P2203 injection.
Time frame: from day 1 to day 36
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.
To determine the maximum tolerated dose of P2203
Time frame: from Day 1 to Day 29
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PEG-MetHuG-CSF and Neulasta (Amgen) in people with PK in Healthy Volunteers, run by PharmaEssentia at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of P2203 injection. (time frame: from day 1 to day 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06698861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.