souseikai global clinical research center

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 allow conducting clinical trials in healthy normal volunteers unless the compound directly damages their DNA.

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

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
  • Safety in TQT