Graves' disease
Conditions
Interventions
KSP-0914 suspension will be administered orally to participants in single or multiple doses.
Sponsors
Shimizu Yoshitaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy Japanese participants with a BMI of 18.5 kg/m2 or higher and less than 25 kg/m2, and healthy Caucasian participants with a BMI of 18.5 kg/m2 or higher and less than 30 kg/m2 - Male participants with a body weight of 50 kg or more and less than 90 kg, and female participants with a body weight of 45 kg or more and less than 90 kg - Female participants who had experienced at least two menstrual periods in the three months prior to screening examination
Exclusion criteria
Exclusion criteria: Participants who have any abnormal finding in medical examination, vital signs, or 12-lead ECG, which is considered by the principal investigator or subinvestigator to be clinically significant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of adverse events and adverse drug reactions - Plasma concentrations and pharmacokinetic profile of KSP-0914 and metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| - Ratio of pharmacokinetic parameters of KSP 0914 and metabolites - Changes from baseline in thyroid-related hormones | — |
Contacts
Public ContactYoshitaka Shimizu
Kissei Pharmaceutical Co., Ltd.
Outcome results
None listed