臨床研究等提出・公開システム

A randomized, single-center, double-blind, placebo-controlled, phase 1 study to investigate the safety, tolerability, and pharmacokinetics of single and repeated oral doses of SCO-267 in healthy adults and subjects with impaired glucose tolerance

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

96

Healthy Japanese male subjects, healthy Caucasian male subjects, Japanese subjects with glucose intolerance

A total of 219 subjects provided informed consent to participate in the study. Of them, 96 were randomized. All of the 96 randomized subjects received at least 1 dose of the randomly assigned study drug and were therefore included in the safety analysis set, PK analysis set, and PD analysis set.

No deaths, serious TEAEs, or TEAEs leading to study drug discontinuation were reported in the study. The most common TEAEs were diarrhoea, nausea, decreased appetite, and vomiting.

[Safety] Overall, the single oral dose administration of SCO-267 at a dose range from 5 mg to 320 mg to Japanese subjects, at 320 mg to Caucasian subjects, and at 40 mg and 80 mg to Japanese subjects with impaired glucose tolerance, with the repeated oral dose administration of SCO-267 at 80 mg and 160 mg to Japanese subjects, were safe and well tolerated. [Pharmacokinetics] Following the single-dose administration of SCO-267 at a dose range from 5 mg to 320 mg to Japanese subjects, the plasma concentration of SCO-267 increased with the dose. When SCO-267 at 80 mg and 160 mg was administered once daily to Japanese subjects for 4 days, plasma concentration reached a steady state by Day 2. No remarkable accumulation of SCO-267 was observed. Urinary excretion of SCO-267 was negligible.

[Pharmacodynamics] Following the single-dose administration of SCO-267 at 40 mg and 80 mg to Japanese subjects with glucose intolerance loaded with 75 g glucose, blood glucose level remarkably decreased with the dose of SCO-267 compared with the placebo. Also serum/plasma hormones involved in glucose metabolism (i.e. insulin, glucagon, GLP-1, GIP, PYY) increased with the dose. of SCO-267

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.

July. 28, 2021

https://diabetes.diabetesjournals.org/lookup/doi/10.2337/db21-0451

No

SCOHIA PHARMA, Inc.

26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa

SCOHIA PHARMA, Inc.

26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa

completed

Dec. 09, 2019

Interventional

Randomized, single-center, double-blind, placebo-controlled study

other

1

-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)

-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.

Male

Healthy male adult, subjects with impaired glucose tolerance

investigational material(s)
Generic name etc : SCO-267
INN of investigational material : -
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : [Single-dose part] SCO-267 5 mg, 10 mg, 20 mg, 40 mg, 80 mg, 160 mg, or 320 mg will be administered orally in a single dose while fasting in the morning. [Repeat-dose part] SCO-267 80 mg or 160 mg will be administered once daily while fasting in the morning for 7 days.

control material(s)
Generic name etc : SCO-267 placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : [Single-dose part] SCO-267 placebo will be administered orally in a single dose while fasting in the morning. [Repeat-dose part] SCO-267 placebo will be administered once daily while fasting in the morning for 7 days.

safety
pharmacokinetics
[Single-dose part]
Safety: Adverse events, vital signs, body weight, safety assessment ECG, continuous digital 12-lead Holter ECG (Japanese healthy adult males only), laboratory tests
Pharmacokinetics: Plasma concentrations and urinary excretions of SCO-267
[Repeat-dose part]
Primary endpoint
Safety: Adverse events, vital signs, body weight, safety assessment electrocardiogram, laboratory tests
Pharmacokinetics: Plasma concentrations and urinary excretions of SCO-267

pharmacodynamics
[Single-dose part]
Pharmacodynamic effects (only in subjects with impaired glucose tolerance):75 g oral glucose tolerance test (75 g OGTT), plasma insulin concentration, plasma glucagon concentration, plasma GLP-1 concentration, plasma GIP concentration, and plasma PYY concentration
[Repeat-dose part]
Pharmacodynamic effects: Plasma GLP-1 concentration, Plasma GIP concentration, Plasma PYY concentration, Plasma glucagon concentration, Plasma insulin concentration

Nov. 21, 2019