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

JRCT ID: jRCT2031210091

Registered date:17/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 07/07/2021
• Target sample size: 32
• Study type: Interventional
• Intervention(s): RO7126209 (trontinemab) : RO7126209 will be administered once intravenously at designated dose

Outcome(s)

Primary Outcome

safety
Observation

Secondary Outcome

safety
Measurement

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Nanki Toshihiro