臨床研究等提出・公開システム

Date of registration	June. 11, 2020
Last modified on	Aug. 17, 2022
Trial ID	jRCT1080225227

Scientific Title	Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial to investigate tolerability, safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SCO-094 subcutaneously administered in patients with type 2 diabetes
Public Title	Safety, tolerability, PK and PD of SCO-094 in type 2 diabetic patients

Completion Date or Terminated date	Dec. 23, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa
	Phone Number
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Aug. 05, 2020
Target Sample Size		68
Study Type		Interventional
Study Design	Study Design	Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Type 2 diabetic Caucasian male or females will be included if they are aged between 18 and 65 (inclusive), with a body mass index (BMI) between 18.0 and 35.0 kg/m2. Patients must be stable and treated with either diet and exercise alone or an anti-glycaemic monotherapy (metformin, DPP-4i, pioglitazone, an SU or an SGLT-2i). Patients must agree to use effective methods of contraception.
	Exclusion Criteria	Patients treated with insulin such as type 1 diabetes or evidence of C-peptide deficiency and patients with current or recurrent disease; e.g., cardiovascular, haematological, neurological, endocrine, immunological, renal, hepatic or gastrointestinal or other conditions) that could affect the action, absorption, or disposition of SCO-094, or could affect clinical assessments or clinical laboratory evaluations.
	Minimum Age	18age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		Type 2 diabetes
Intervention(s)		investigational material(s) Generic name etc : SCO-094 INN of investigational material : - Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Part 1: A single dose of trial treatment on Day1. Part 2: A single dose of trial treatment once daily on Days 1 to 5. control material(s) Generic name etc : SCO-094 placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Part 1: A single dose of trial treatment on Day1. Part 2: A single dose of trial treatment once daily on Days 1 to 5.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety The safety and tolerability of SCO-094 as measured by the incidence of treatment emergent adverse events (TEAEs), proportion of patients with clinically significant changes in laboratory safety tests (haematology, chemistry, coagulation, and urinalysis), proportion of patients with morphological and/or rhythm abnormalities on electrocardiogram (ECG), proportion of patients with clinically significant changes in ECG time intervals (PR, QRS, QT and QTc intervals) and proportion of patients with clinically significant changes in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation and body temperature).
Secondary Outcome		pharmacokinetics PK endpoints

Primary Sponsor	SCOHIA PHARMA, Inc.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	London Bridge REC
Address	Health Research Authority Skipton House 80 London Road SE1 6LH
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	June. 08, 2020

Secondary ID No.	JapicCTI-205323
Name of Other Registries

Countries / Regions of Recruitment	Europe

History of Changes

No	Publication date
4	Aug. 17, 2022	(this page)	Changes
3	Aug. 25, 2021	Detail	Changes
2	Aug. 07, 2020	Detail	Changes
1	June. 12, 2020	Detail

List of change history