Healthy ParticipantsPhase 1NCT07738991
A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers
A Phase 1 study testing NKF-PEG and US-Neulasta in people with Healthy Participants, run by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- NKF-PEG and US-Neulasta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2026to 12 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be 18 to 55 years of age, at the time of signing the informed consent.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5-30.0 kg/m2 (inclusive).
- Male assigned at birth, inclusive of all gender identities. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants:
- Participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
- •Refrain from donating sperm
Show all 13Show fewer
- PLUS, either:
- Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent.
- OR
- Must agree to use contraception as detailed below:
- Agree to use birth control (2 highly effective methods of contraception including 1 barrier method) when having sexual intercourse with a partner able to give birth who is not currently pregnant.
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Willingness to follow protocol defined restrictions and Investigator/staff instructions and protocol procedures.
Who cannot join
- Sensitivity to any of the study interventions, or components thereof including E. coli derived proteins, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- With any clinically significant abnormalities identified during screening in physical examination, vital signs, laboratory tests, or 12-lead ECG.
- History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator.
- Evidence of active infection, including chronic or localized infections, by history, physical examination findings, or laboratory data, as determined by the Investigator within 1 week prior to Day 1.
- Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment.
- History or presence of any condition that in the opinion of the Investigator would constitute a risk when taking the study intervention or interfere with the interpretation of data.
- A history of alcohol abuse within 3 months prior to screening (alcohol consumption of more than 14 units per week: 1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,
Zhengzhou
mingming yao, +86 159 3878 2220, hxmsllwyh@163.com
About this study
Official title: A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers
A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers
Read the detailed description
Participants will be admitted to the clinical research unit (CRU) on Day -1. Eligible participants will be randomized (1:1) on Day -1 to 1 of 2 treatment sequences. Participants will then receive a single 6 mg SC dose during Treatment Period 1 of either NKF-PEG, or US-Neulasta, according to the randomization schedule. Participants will be discharged from the CRU on Day 13 and will return to the CRU on Day 16 for PK/PD analysis and for safety assessments.
Following the washout period of 6 weeks, the same schedule will be followed for Treatment Period 2, where participants will receive a single 6 mg SC dose of the final product according to their treatment sequence, then discharge from the CRU on Day 13 of Treatment Period 2 and will return for ambulatory visits on Day 16 of Treatment Period 2 and Safety Visit (Day 84).
- Conditions
- Healthy Participants
- Being tested
- NKF-PEG, US-Neulasta
- Keywords
- Pegfilgrastim, Pharmacokinetic, Pharmacodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKF-PEGBiological
NKF-PEG administered as a single 6 mg SC dose in the periumbilical area
US-NeulastaBiological
US-Neulasta administered as a single 6 mg SC dose in the periumbilical area
| Study group | Role | What they receive |
|---|---|---|
| NKF-PEG | Experimental | Not described Receives: Biological: NKF-PEG |
| US-Neulasta® | Active comparator | Not described Receives: Biological: US-Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the concentration-time curve from time 0 to the last quantifiable concentration
Measured: 0 to 360 hours
Cmax
Maximum observed serum concentration
Measured: 0 to 360 hours
AUEC0- t for ANC
Area under the effect curve for ANC
Measured: 0 to 360 hours
Emax of ANC
Maximum response (Emax) of ANC
Measured: 0 to 360 hours
Secondary outcomes (12)
AUC0-inf
Area under the concentration-time curve from time 0 extrapolated to infinity
Measured: 0 to 360 hours
Tmax
Time to Cmax
Measured: 0 to 360 hours
T1/2
Terminal half-life
Measured: 0 to 360 hours
Tmax of ANC
Time to Emax of ANC
Measured: 0 to 360 hours
Tmax of CD34+ cell count
Time to Emax of CD34+ cell count
Measured: 0 to 360 hours
AUEC0-t of CD34+ cell count
Area under the effect curve of CD34+ cell count
Measured: 0 to 360 hours
Emax of CD34+ cell count
Maximum response (Emax) of CD34+ cell count
Measured: 0 to 360 hours
The proportion of participants with treatment-induced anti-pegfilgrastim antibodies at any time during the study
Measured: 0-84 days
The proportion of participants with treatment-induced anti-filgrastim antibodies at any time during the study
Measured: 0-84 days
The proportion of participants with treatment-induced anti-PEG antibodies at any time during the study
Measured: 0-84 days
The proportion of participants with post dose positive neutralizing antibody result of pegfilgrastim at any time during the study
Measured: 0-84 days
Adverse event (AE) assessments (including injection site reactions)
Frequency of Adverse event (AE) (including injection site reactions)
Measured: 0-84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start3 Jul 2026
- Primary completion9 Nov 2026 (estimated)
- Study completion12 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Crossover Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738991
- Sponsor's protocol ID
- NKF-PEG-101
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT07738991
- Acronym / sponsor ID
- NKF-PEG-101
- Conditions
- Healthy Participants
- Keywords
- Pegfilgrastim, Pharmacokinetic, Pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- 9 Nov 2026 (estimated)
- Study completion
- 12 Apr 2027 (estimated)
- First posted
- 31 Jul 2026 (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.
A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers
Detailed description
Participants will be admitted to the clinical research unit (CRU) on Day -1. Eligible participants will be randomized (1:1) on Day -1 to 1 of 2 treatment sequences. Participants will then receive a single 6 mg SC dose during Treatment Period 1 of either NKF-PEG, or US-Neulasta, according to the randomization schedule. Participants will be discharged from the CRU on Day 13 and will return to the CRU on Day 16 for PK/PD analysis and for safety assessments.
Following the washout period of 6 weeks, the same schedule will be followed for Treatment Period 2, where participants will receive a single 6 mg SC dose of the final product according to their treatment sequence, then discharge from the CRU on Day 13 of Treatment Period 2 and will return for ambulatory visits on Day 16 of Treatment Period 2 and Safety Visit (Day 84).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Study
| Arm | Type | Receives |
|---|---|---|
| NKF-PEG | Experimental | Biological: NKF-PEG |
| US-Neulasta® | Active comparator | Biological: US-Neulasta |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participant must be 18 to 55 years of age, at the time of signing the informed consent.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5-30.0 kg/m2 (inclusive).
- Male assigned at birth, inclusive of all gender identities. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
- •Refrain from donating sperm
Key exclusion criteria (7 listed)
- Sensitivity to any of the study interventions, or components thereof including E. coli derived proteins, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- With any clinically significant abnormalities identified during screening in physical examination, vital signs, laboratory tests, or 12-lead ECG.
- History or presence of cardiovascular, respiratory, psychiatric, metabolic, hepatic, renal, gastrointestinal, endocrinological, hematological, oncological, or neurological disorders determined to be clinically significant by the Investigator.
- Evidence of active infection, including chronic or localized infections, by history, physical examination findings, or laboratory data, as determined by the Investigator within 1 week prior to Day 1.
- Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment.
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 |
|---|---|---|
| NKF-PEGNKF-PEG administered as a single 6 mg SC dose in the periumbilical area | Biological | NKF-PEG |
| US-NeulastaUS-Neulasta administered as a single 6 mg SC dose in the periumbilical area | Biological | US-Neulasta® |
Primary outcome
AUC0-t
Time frame: 0 to 360 hours
Area under the concentration-time curve from time 0 to the last quantifiable concentration
Cmax
Time frame: 0 to 360 hours
Maximum observed serum concentration
AUEC0- t for ANC
Time frame: 0 to 360 hours
Area under the effect curve for ANC
Emax of ANC
Time frame: 0 to 360 hours
Maximum response (Emax) of ANC
12 secondary outcomes
AUC0-inf
Time frame: 0 to 360 hours
Tmax
Time frame: 0 to 360 hours
T1/2
Time frame: 0 to 360 hours
Tmax of ANC
Time frame: 0 to 360 hours
Tmax of CD34+ cell count
Time frame: 0 to 360 hours
AUEC0-t of CD34+ cell count
Time frame: 0 to 360 hours
Emax of CD34+ cell count
Time frame: 0 to 360 hours
The proportion of participants with treatment-induced anti-pegfilgrastim antibodies at any time during the study
Time frame: 0-84 days
The proportion of participants with treatment-induced anti-filgrastim antibodies at any time during the study
Time frame: 0-84 days
The proportion of participants with treatment-induced anti-PEG antibodies at any time during the study
Time frame: 0-84 days
The proportion of participants with post dose positive neutralizing antibody result of pegfilgrastim at any time during the study
Time frame: 0-84 days
Adverse event (AE) assessments (including injection site reactions)
Time frame: 0-84 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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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.
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 NKF-PEG and US-Neulasta in people with Healthy Participants, run by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. at 1 site in China.
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 13 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jinxi chen (+86 138 4905 6696, chenjinxi6688@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: 0 to 360 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.