Phase 1 Comparative PK/PD and safety study of MYL-1401H Vs G-Lasta

JRCT ID: jRCT2071210138

Registered date:26/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Reduction in the duration of neutropenia and the incidence of Febrile neutropenia in patients treate
• Date of first enrollment: 17/03/2022
• Target sample size: 172
• Study type: Interventional
• Intervention(s): Single dose 3.6 mg MYL-1401H or G-Lasta Subcutaneous Injection administered as subcutaneous injection.

Outcome(s)

• Primary Outcome: PK Endpoints,PD Endpoints
• Secondary Outcome: PK Endpoints,PD Endpoints,Safety Endpoints

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Koichi Iwai