A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers
Recruiting
Phase 1
Interventional Study
Healthy Participants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Male
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 202 (estimated)
- Sponsor
- Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 participa…
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