Single-dose and repeated-dose phase I SCO-267 study

Phase 1

Completed

• Conditions: Healthy male adult, subjects with impaired glucose tolerance

• Registration Number: JPRN-jRCT2080224969
• Lead Sponsor: SCOHIA PHARMA, Inc.

Brief Summary

SCO-267 was safe and well tolerated and exhibits once-daily oral dosing potential. Its robust therapeutic effects on hormonal secretion and glycemic control were shown in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-29
• Study Completion: 2020-11-06
• Results First Posted: 2021-07-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 96

Inclusion Criteria

Healthy adult Japanese males or subjects with impaired glucose tolerance (both parents and grandparents of the subject are Japanese) or healthy adult Caucasian males (both parents and grandparents of the subject are Caucasian)
-Subjects aged 20 to 45 years (excluding cohorts 8, 9, and 12) at the time of informed consent, subjects aged 20 to 70 years at the time of informed consent (cohorts 8 and 9 only), or subjects aged 65 to 85 years at the time of informed consent (cohort 12 only).
-Subjects with body weight >= 50 kg at screening and BMI between 18.5 kg/m2 and 25.0 kg/m2 (excluding cohort 7b, 8, 9 and 12) or with body weight >= 50 kg at screening and BMI between 18.5 kg/m2 and 30.0 kg/m2 (cohort 7b, 8, 9 and 12 only)
-Subjects with a screening HbA1c of 10% or less (cohorts 8 and 9 only)
-Subjects with a blood glucose level of 230 mg/dL 2 hours after the screening 75g oral glucose tolerance test (75 g OGTT) (cohorts 8 and 9 only)

Exclusion Criteria

-Subjects who received investigational product within 16 weeks (112 days) prior to the initiation of investigational product treatment
-Subjects with a C-peptide of 0.5 ng/mL or less at screening (cohorts 8 and 9 only)
-Subjects with neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urinary or endocrine disorders or other abnormalities with poor control and clinically significant problems, who may affect the participation in the clinical trial or the results of the clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified