A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers

NCT07738991 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NKF-PEG-101
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Participants

Keywords

Pegfilgrastim; Pharmacokinetic; Pharmacodynamic

Outcome Measures

Primary Outcomes (4)

• AUC0-t

  Area under the concentration-time curve from time 0 to the last quantifiable concentration

  0 to 360 hours

• Cmax

  Maximum observed serum concentration

  0 to 360 hours

• AUEC0- t for ANC

  Area under the effect curve for ANC

  0 to 360 hours

• Emax of ANC

  Maximum response (Emax) of ANC

  0 to 360 hours

Secondary Outcomes (12)

• AUC0-inf

  0 to 360 hours

• Tmax

  0 to 360 hours

• T1/2

  0 to 360 hours

• Tmax of ANC

  0 to 360 hours

• Tmax of CD34+ cell count

  0 to 360 hours

Study Arms (2)

NKF-PEG

EXPERIMENTAL

Biological: NKF-PEG

US-Neulasta®

ACTIVE COMPARATOR

Biological: US-Neulasta

Interventions

NKF-PEG BIOLOGICAL

NKF-PEG administered as a single 6 mg SC dose in the periumbilical area

NKF-PEG

US-Neulasta BIOLOGICAL

US-Neulasta administered as a single 6 mg SC dose in the periumbilical area

US-Neulasta®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,

Zhengzhou, China

RECRUITING

Central Study Contacts

jinxi chen

CONTACT

+86 138 4905 6696; chenjinxi6688@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical Research Coordinator
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover Study

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 31, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): November 9, 2026
• Study Completion (Estimated): April 12, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CN (1)