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
Inclusion Criteria:
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.
Exclusion Criteria:
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Clinical Research Coordinator
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