Not Yet RecruitingPhase 1ACTRN12610000363088

Effect of Ascending dose of F-627 in Healthy Male Volunteers

Phase I, Open Labeled, Dose Escalation trial in healthy male subjects to examine the Pharmacokinetics, Pharmacodynamics, and safety of single dose usage of F-627.

Sponsor

Nucleus Network

Enrollment

24 participants

Start Date

May 10, 2010

Study Type

Interventional

Conditions

Neutropenia

Summary

Neutropenia is a complex haematological disorder charactarised by a abnormally low level of neutrophils in the blood. F-627 is being developed to treat neutropenia especially for the management of neutropenia in patients with cancer. F-627 is being developed by Generon (Shanghai) Corporation to provide additional benefits to cancer patients by shortening the duration and lessening the severity of neutropenia after chemotherapy. The purpose of this study is to researech the safety of the use of F-627 in Healthy Male Volunteers. There will be no benefits from participating in this trial, Patients will receive only one dose of study drug.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests increasing doses of a new drug called F-627 in healthy men aged 18-45 to check its safety and how the body handles it. F-627 is being developed to help the body produce white blood cells. Participants must be in good health with normal blood counts and organ function.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ascending dose of F-627 Cohort 1 will receive 30ug/kg F-627 in a single subcutaneous dose Cohort 2 will receive 60ug/kg F-627 in a single subcutaneous dose Cohort 3 will receive 120ug/kg F-627 in a

Ascending dose of F-627 Cohort 1 will receive 30ug/kg F-627 in a single subcutaneous dose Cohort 2 will receive 60ug/kg F-627 in a single subcutaneous dose Cohort 3 will receive 120ug/kg F-627 in a single subcutaneous dose Cohort 4 will receive 240ug/kg F-627 in a single subcutaneous dose