Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects

Single-dose-administration study of GT-02037 subcutaneous injection in healthy Japanese male subjects - GT-02037 single dose study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028302

Enrollment

Registered

2017-07-20

Start date

2017-07-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Interventions

GT-02037 (0.1, 0.5, 1.0, 2.0mg) single dose

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAyaka Kiyota

Pharmaspur Inc. Clinical study

ayaka_kiyota@pharmaspur.com03-6214-2670

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026