Oncology Studies in Healthy Volunteers

Compared to the past chemotherapeutic agents, oncology drugs' recent improvements enable us to obtain more focused therapeutic effects without damaging healthy cells in the human body.

Based on the scientific grounds and thorough investigation of benefits over potential risks, global regulators now openly allow starting clinical trials in healthy normal volunteers depending on the nature of the drugs.

At SOUSEIKAI, we have actively engaged in FIH/Phase 1 Oncology Studies in healthy volunteers, leveraging our experience and know-how with healthy volunteer studies.

Our experience with Oncology Studies includes:

• FIH Studies
• Phase 1 SAD, MAD Studies
• Food Effect Study in accordance with the FDA guidance
• Japanese PK Studies
• Female Studies
• TQT Studies
• Biosimilar Phase 1 Studies

Advantages of Oncology Studies in Healthy Volunteers

• Unbiased safety and PK profiles
• Overall reductions in study cost and time compared to cancer patient studies
• Speedy subject enrolment
• Uncomplicated assessments of key aspects, such as TQT, FE, DDI, and Female Studies