A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers
- 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
- Short title
- A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-04-12
- First posted
- 2026-07-31
- Registry last updated
- 2026-07-31
- Primary completion date
- 2026-11-09
- Start date
- 2026-07-03
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07738991
- ClinicalTrials.gov ID
- NCT07738991
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Quadruple masking
- Masking description
- Clinical Research Coordinator
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
AUC0-t
Timeframe: 0 to 360 hours
Area under the concentration-time curve from time 0 to the last quantifiable concentration
Cmax
Timeframe: 0 to 360 hours
Maximum observed serum concentration
AUEC0- t for ANC
Timeframe: 0 to 360 hours
Area under the effect curve for ANC
Emax of ANC
Timeframe: 0 to 360 hours
Maximum response (Emax) of ANC
AUC0-inf
Timeframe: 0 to 360 hours
Area under the concentration-time curve from time 0 extrapolated to infinity
Tmax
Timeframe: 0 to 360 hours
Time to Cmax
T1/2
Timeframe: 0 to 360 hours
Terminal half-life
Tmax of ANC
Timeframe: 0 to 360 hours
Time to Emax of ANC
Tmax of CD34+ cell count
Timeframe: 0 to 360 hours
Time to Emax of CD34+ cell count
AUEC0-t of CD34+ cell count
Timeframe: 0 to 360 hours
Area under the effect curve of CD34+ cell count
Emax of CD34+ cell count
Timeframe: 0 to 360 hours
Maximum response (Emax) of CD34+ cell count
The proportion of participants with treatment-induced anti-pegfilgrastim antibodies at any time during the study
Timeframe: 0-84 days
The proportion of participants with treatment-induced anti-filgrastim antibodies at any time during the study
Timeframe: 0-84 days
The proportion of participants with treatment-induced anti-PEG antibodies at any time during the study
Timeframe: 0-84 days
The proportion of participants with post dose positive neutralizing antibody result of pegfilgrastim at any time during the study
Timeframe: 0-84 days
Adverse event (AE) assessments (including injection site reactions)
Timeframe: 0-84 days
Frequency of Adverse event (AE) (including injection site reactions)
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
-
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.
a. 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
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.
- 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).
- Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,Zhengzhou, ChinaRecruiting