JRCT ID: jRCT2071220046
Registered date:27/08/2022
A RELATIVE AND ABSOLUTE BIOAVAILABILITY STUDY OF AMY109 WITH HEALTHY MALE VOLUNTEERS
Basic Information
Recruitment status | Complete |
---|---|
Health condition(s) or Problem(s) studied | Endometriosis |
Date of first enrollment | 07/10/2022 |
Target sample size | 60 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | AMY109 is administered subcutaneously at the prescribed dose. AMY109 is administered intravenously at the prescribed dose. |
Outcome(s)
Primary Outcome | Safety, Bioavailability, Phamacokinetics Adverse Events and Adverse Drug Reactions Vital Signs 12 lead ECG Laboratory Values Plasma AMY 109 concentration and pharmacokinetic parameters |
---|---|
Secondary Outcome | Other Anti-AMY109 antibody in plasma |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
---|---|
Age maximum | <= 55age old |
Gender | Male |
Include criteria | Written informed consent must be obtained from the subject. Body mass index (BMI) between 18.5 and < 30.0 kg/m2 at screening. |
Exclude criteria | Subject with cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, or pulmonary disease. History of malignancy or leukemia within 10 years before screening. |
Related Information
Primary Sponsor | Hashimoto Akiko |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Clinical trials information |
Address | 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120-189-706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Akiko Hashimoto |
Address | 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120-189-706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |