> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-pharmacokinetics-pharmacodynamics-c530f908-7900-4a20-a3dd-8b30f050b050 > Record changed: 2026-10-13 # A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers NCT07738991 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) Participants 202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) Lead sponsor Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) Start date 2026-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Short title** A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Dates **Completion date** 2027-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **First posted** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Primary completion date** 2026-11-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Start date** 2026-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Size and sites **Participants** 202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Planned participants** 202 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Lead sponsor** Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Identifiers **Registry ID** NCT07738991 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **ClinicalTrials.gov ID** NCT07738991 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Other **Masking** Quadruple masking **Masking description** Clinical Research Coordinator **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Outcomes ### Primary outcomes 1. AUC0-t Timeframe: 0 to 360 hours Area under the concentration-time curve from time 0 to the last quantifiable concentration 2. Cmax Timeframe: 0 to 360 hours Maximum observed serum concentration 3. AUEC0- t for ANC Timeframe: 0 to 360 hours Area under the effect curve for ANC 4. Emax of ANC Timeframe: 0 to 360 hours Maximum response (Emax) of ANC ### Secondary outcomes 1. AUC0-inf Timeframe: 0 to 360 hours Area under the concentration-time curve from time 0 extrapolated to infinity 2. Tmax Timeframe: 0 to 360 hours Time to Cmax 3. T1/2 Timeframe: 0 to 360 hours Terminal half-life 4. Tmax of ANC Timeframe: 0 to 360 hours Time to Emax of ANC 5. Tmax of CD34+ cell count Timeframe: 0 to 360 hours Time to Emax of CD34+ cell count 6. AUEC0-t of CD34+ cell count Timeframe: 0 to 360 hours Area under the effect curve of CD34+ cell count 7. Emax of CD34+ cell count Timeframe: 0 to 360 hours Maximum response (Emax) of CD34+ cell count 8. The proportion of participants with treatment-induced anti-pegfilgrastim antibodies at any time during the study Timeframe: 0-84 days 9. The proportion of participants with treatment-induced anti-filgrastim antibodies at any time during the study Timeframe: 0-84 days 10. The proportion of participants with treatment-induced anti-PEG antibodies at any time during the study Timeframe: 0-84 days 11. The proportion of participants with post dose positive neutralizing antibody result of pegfilgrastim at any time during the study Timeframe: 0-84 days 12. Adverse event (AE) assessments (including injection site reactions) Timeframe: 0-84 days Frequency of Adverse event (AE) (including injection site reactions) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Participant must be 18 to 55 years of age, at the time of signing the informed consent. 2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18.5-30.0 kg/m2 (inclusive). 3. 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. 4. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 5. Willingness to follow protocol defined restrictions and Investigator/staff instructions and protocol procedures. ### Exclusion criteria 1. 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. 2. With any clinically significant abnormalities identified during screening in physical examination, vital signs, laboratory tests, or 12-lead ECG. 3. 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. 4. 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. 5. Rash, scarring, dermatological condition, or tattoo in the area of the injection site that could interfere with the injection or injection site assessment. 6. 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. 7. 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). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Sites - Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,Zhengzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07738991) ## Related records ### Drugs (1) - [Pegfilgrastim](https://trialight.com/data/asset/pegfilgrastim-1d67f09f-a3d2-4dbc-bfb9-efed1a49c050.md) ### Lead sponsors (1) - [Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.](https://trialight.com/data/company/nanjing-king-friend-biochemical-pharmaceutical-co-ltd-7aa0a1f6-69b7-4685-830d-90014a91b64c.md) ### Targets (1) - [CSF3R](https://trialight.com/data/target/csf3r-7b84eab7-d92f-5a62-9246-8b76c06b0b44.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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