A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neul… (NCT07738991) | Clinical Trial Compass
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers
China202 participantsStarted 2026-07-03
Plain-language 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
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).