Status:

COMPLETED

Study in Healthy Adult Female Subjects

Lead Sponsor:

InventisBio Co., Ltd

Conditions:

Mass Balance Recovery

Eligibility:

FEMALE

18-65 years

Phase:

PHASE1

Brief Summary

An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of \[14C\] D-0502 Following Single Oral Dose Administration

Eligibility Criteria

Inclusion

  • Healthy adult female volunteers not of child-bearing potential between the ages of 18 and 65. Other inclusion criteria will be reviewed by the Principal Investigator.

Exclusion

  • History or presence of any condition or prior surgery that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
  • Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG, or laboratory tests
  • Other exclusion criteria will be reviewed by the Principal Investigator.

Key Trial Info

Start Date :

March 29 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 31 2022

Estimated Enrollment :

8 Patients enrolled

Trial Details

Trial ID

NCT05339633

Start Date

March 29 2022

End Date

October 31 2022

Last Update

April 6 2023

Active Locations (1)

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1

Site Location

Baltimore, Maryland, United States, 21201