NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210091

Registered date:17/05/2021

A Phase I Single Ascending Dose Study of RO7126209 in Healthy Japanese Subjects

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedAlzheimer's disease
Date of first enrollment07/07/2021
Target sample size32
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)RO7126209 will be administered once intravenously at designated dose

Outcome(s)

Primary Outcomesafety Observation
Secondary Outcomesafety Measurement

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 40age old
GenderMale
Include criteria1. Written informed consent. 2. Healthy Japanese man who is 20 to 40 years of age at the time of informed consent. 3. Individuals who are judged to be healthy based on their medical, history surgical history, or physical examination. 4. Body mass index (weight [kg]/[height [m]2) of 18.5 to 25.0 kg/m2 at screening. 5. Individuals who have agreed to abstinence or to use contraception methods and to refrain from sperm donation during the study treatment period and for a certain period after administration of the investigational drug.
Exclude criteria1. Individuals with cardiovascular, renal, hepatic, gastrointestinal, immunological, neurological, endocrine, metabolic, cerebrovascular, or bronchopulmonary diseases and individuals with a history of these diseases and disorder kidney, liver, or cardiorespiratory function. 2. Individuals affected by hypersensitivity to biological products or excipients in pharmaceutical products. 3. Subjects who participated in any clinical trial within 4 months before administration of the investigational product and who received the investigational product (including placebo). 4. Individuals who have received or have taken prescription drugs within 1 month before administration of the investigational product.

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 Toshihiro Nanki
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 Division of Rheumatology, Department of internal Medicine, Toho University School of Medicine