NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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) studiedEndometriosis
Date of first enrollment07/10/2022
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)AMY109 is administered subcutaneously at the prescribed dose. AMY109 is administered intravenously at the prescribed dose.

Outcome(s)

Primary OutcomeSafety, Bioavailability, Phamacokinetics Adverse Events and Adverse Drug Reactions Vital Signs 12 lead ECG Laboratory Values Plasma AMY 109 concentration and pharmacokinetic parameters
Secondary OutcomeOther Anti-AMY109 antibody in plasma

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 55age old
GenderMale
Include criteriaWritten informed consent must be obtained from the subject. Body mass index (BMI) between 18.5 and < 30.0 kg/m2 at screening.
Exclude criteriaSubject 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

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
E-mail 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
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co., Ltd.