臨床研究等提出・公開システム

単施設、無作為化、プラセボ対照、二重盲検、単回・反復皮下投与試験

A single-center, randomized, double-blind, placebo-controlled single and multiple subcutaneous injection study

(1)健康な日本人成人男性
(2)20歳以上40歳以下の者（同意取得時）
(3)体重が50kg以上の者
(4)BMIが18.5以上25.0未満の者（スクリーニング検査時）
(5)文書による同意が得られた者

(1) Healthy Japanese adult male
(2) 20 to 40 years old at the time of consent
(3) Body weight: over 50 kg
(4) Body Mass Index: between 18.5 and 25.0 at the screening examination
(5) Provided written informed consent

(1)中枢神経系、循環器系、呼吸器系、血液・造血機能系、消化管系、肝・腎機能などに本治験に不適当と考えられる既往歴を有する者
(2)薬物等に対する過敏症又は特異体質がある者
(3)本治験に不適当と考えられる食物アレルギー又はアレルギー疾患を有する者
(4)発疹（紅斑・膨疹等）の過敏症状を起こしやすい体質の者
(5)アルコール又は薬物依存者
(6)免疫学的検査（HBs抗原、HCV抗体、梅毒検査（RPR法、TP抗体）、HIV抗原・抗体）の結果、異常が認められた者
(7)尿中薬物スクリーニング検査において陽性であった者
(8)治験薬投与前1週間以内にアルコール、グレープフルーツ（果実・果肉）、セント・ジョーンズ・ワートを含有する食品・サプリメントを摂取した者
(9)治験薬投与1週間以内に筋肉痛を伴うような激しい運動や日焼けをした者
(10)治験薬投与前2週間以内に何らかの薬剤を使用した者
(11)治験薬投与前16週間以内（他の生物学的同等性試験の場合には、12週間以内）に他の治験又は臨床試験等に参加し薬剤の投与を受けた者
(12)治験薬投与前12週間以内に400mL以上、4週間以内に200mL以上の全血採血、又は2週間以内に成分採血をした者
(13)治験薬投与後から事後検査（又は追跡検査）まで避妊ができない者
(14)GT-02037 又はソマトスタチンアナログ製剤の投与経験のある者
(15)スクリーニング検査時の臨床検査、バイタルサイン、12誘導心電図検査、診察において、臨床的に有意な異常が認められた者
(16)その他、治験責任医師又は治験分担医師が本治験参加に不適当と判断した者

(1) Those who have prior medical history of central nervous system, circulatory system, respiratory system, blood / hematopoietic system, gastrointestinal system, hepatic / renal function, etc. conditions that are considered inappropriate for this study
(2) Hypersensitivity or idiosyncratic reaction to any drug
(3) Those having a food allergy or allergic disease considered inappropriate for this study
(4) Those who are susceptible to hypersensitivity rash symptoms (erythema, wheal, etc.)
(5) Alcohol or drug dependence
(6) Those having immunological test result abnormalities (HBs antigen, HCV antibody, syphilis test (RPR method, TP antibody), HIV antigen / antibody)
(7) Those who have a positive result in the urine drug screening test
(8) Those who have consumed foods / supplements containing alcohol, grapefruit (fruit / pulp), or St. John's wort within one week prior to investigational drug administration
(9) Those who have experienced muscle pain due to intense exercise or sunburn within one week prior to investigational drug administration
(10) Those administrated of any investigational drug within two weeks before this study
(11) Those who have participated in other clinical trials or studies and received the drug within 16 weeks before this study (in the case of other clinical bioequivalence studies, within 12 weeks)
(12) Those who have given 400mL or more of whole blood within 12 weeks, 200mL or more within 4 weeks, or blood components within 2 weeks before this study
(13) Those who cannot practice contraception from the administration of the investigational drug to post-test (or follow-up)
(14) Those previously administrated GT-02037 or somatostatin analog drug
(15) Those with clinically significant abnormalities in laboratory tests, vital signs, 12-lead ECG tests, or medical examinations at the time of subject screening
(16)Those who are judged by the clinical investigator or sub-investigators to be inappropriate for participation in this study

20歳以上

20age old over

40歳以下

40age old under

男性

Male

試験完了

completed