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.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000363088

Enrollment

Registered

2010-05-06

Start date

2010-05-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 single subcutaneous dose Cohort 4 will receive 240ug/kg F-627 in a single subcutaneous dose

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects must be healthy male volunteers * Subjects must have a body mass index greater than or equal to 19 (kg/m2)and less than or equal to 34 (kg/m2). *No clinically significant findings in the medical and physical examination, especially normal full blood count (at screening), hepatic and renal function.

Exclusion criteria

* Family history of premature CHD (Coronary Heart Disease) * Any condition which can cause splenomegaly * Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to screening * Prior history of a haematological malignancy, or current history of a haematological disorder (even if it does not require treatment) * Any abnormality of red cell count, mean corpuscular volume,platelet count, white cell count or white cell differential * Subjects at risk of tuberculosis (TB)

Outcome results