Reduction in the duration of neutropenia and the incidence of Febrile neutropenia in patients treate
Conditions
Interventions
Single dose 3.6 mg MYL-1401H or G-Lasta Subcutaneous Injection administered as subcutaneous injection.
Sponsors
Koichi Iwai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible at the screening visit (unless otherwise stated) if all of the Protocol apply 1 Willingness and ability to provide informed consent. 2 Japanese male and/or female 3 Age: 20-55 years, inclusive. 4 Weight: >45 kg. In addition, follow the criteria of the clinical trial protocol
Exclusion criteria
Exclusion criteria: A subject will be not be eligible at the screening visit (unless otherwise stated) if any of the Protocol apply 1 Unable to follow protocol instructions in the opinion of the PI/SI. 2 Any past or concurrent medical conditions that potentially increase the subjects risks or affect the evaluation of any study results. Examples of these include medical history with evidence of clinically relevant pathology (e.g., sickle cell disorders,spleen pathologies, hematologic malignancies or myelodysplastic disorders, and pulmonary illnesses such as acute respiratory distress syndrome (ARDS), interstitial pneumonia, pulmonary edema, pulmonary infiltrates and pulmonary fibrosis) and history of relevant drug and/or food allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK Endpoints,PD Endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| PK Endpoints,PD Endpoints,Safety Endpoints | — |
Contacts
Public ContactClinical trials information
CMIC Co., Ltd.
Outcome results
None listed