UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects
Title of the study (Brief title)	GT-02037 single dose study
Region	Japan

Condition
Condition	Acromegaly
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary objective Investigation for safety of GT-02037 in male healthy adult subjects. Secondary objective Investigation for pharmacokinetics of GT-02037.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of GT863 Physical examination (The day prior to administration (Day-1), Pre, 1*, 4, 24, 48hours, Follow up (Day7) ) Injection site reaction (Pre, 1*, 4, 24, 48hours, Day7) Vital sign (Day-1, Pre, 1*, 4, 24, 48hours, Day7) Electrocardiogram (Day-1, 1*, 4, 24hours, Day7) SpO2 (Pre, 15minutes) Laboratory examination (Day-1, 24hours, Day7) Adverse event * Only Step 1
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	GT-02037 (0.1, 0.5, 1.0, 2.0mg) single dose
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	(1) Japanese male healthy adult subjects (2) between 20 and 40 years old (3) Body weight over 50 kg (4) BMI over 18.5 under 25.0 kg/m2 (5) Having given written informed consent prior to any procedure related to the study
Key exclusion criteria	(1) Any subject who have present and/or past history of disease of heart and circulatory system, liver, kidney, digestive system, and blood system, central nerves system, respiratory system. (2) Hypersensitivity or Idiosyncratic to drugs (3) History of allergy to any clinically important allergy (4) A constitution prone to hypersensitivity reaction such as rash (erythema, wheal, etc) (5) Any subject have present and/or past history of drug and alcohol addiction. (6) Positive serologic findings for treponema pallidum (syphilis), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg),and/or hepatitis C virus (HCV) antibodies. (7) Positive findings of urine drug screen. (8) Any drug history within 2weeks before study day 1. (9) Use of any investigational drug within 16weeks before study day 1. (10) Donation of blood over 400mL within 14 weeks, 200mL within 4weeks before study day 1. Blood compornent donation within 2weeks. (11) Any subject not able to agree to make contraception during the study. (12) A past medical history of somatostatin analog administration (13) Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results. (14) Subjects deemed by the investigator to be inappropriate according for inclusion in the study.
Target sample size	24

Research contact person
Name of lead principal investigator	Setsuo Hasegawa
Organization	Pharmaspur Inc.
Division name	Internal medicine
Address	1-2-10 Nihonbashi. Chuo-ku, Tokyo, Japan
TEL	03-6214-2670
Email	setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person	Ayaka Kiyota
Organization	Pharmaspur Inc.
Division name	Clinical study
Address	1-2-10 Nihonbashi. Chuo-ku, Tokyo, Japan
TEL	03-6214-2670
Homepage URL
Email	ayaka_kiyota@pharmaspur.com

Sponsor
Institute	Pharmaspur Inc.
Institute
Department

Funding Source
Organization	Gly Tech, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 20 Day
Last modified on	2017 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032128