臨床研究等提出・公開システム

Dose escalation study of single and multiple subcutaneous injections of GT-02037 in healthy Japanese adult males

Phase1 study of GT-02037 in Healthy Volunteers

No

GlyTech, Inc.

134, Chudoji minami-machi, Shimogyo-ku, Kyoto

taiji-shimoda@glytech.jp

GlyTech, Inc.

134, Chudoji minami-machi, Shimogyo-ku, Kyoto

+81-75-315-9218

taiji-shimoda@glytech.jp

completed

Mar. 16, 2020

Interventional

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

treatment purpose

1

(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) 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

Male

Healthy adult subjects

investigational material(s)
Generic name etc : GT-02037
INN of investigational material : -
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Dosage and Administration for Investigational material : Subcutaneous injection

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Subcutaneous injection

safety
AEs, Clinical examination, Injection site reaction, Vital signs, 12-lead ECGs, Laboratory tests

pharmacokinetics
pharmacodynamics
Secondary endopoint: Pharmacokinetics(Plasma GT-02037 concentrations, urinary GT-02037 excretions, PK parameters)
Exploratory endopoint: Pharmacodynamics(Insulin, Glucagon, HbA1c, IGF-1)

+81-92-283-7701

Feb. 28, 2020