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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031210091
Enrollment
32
Registered
2021-05-17
Start date
2021-07-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers disease

Interventions

RO7126209 (trontinemab) : RO7126209 will be administered once intravenously at designated dose

Sponsors

Nanki Toshihiro
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
safety Observation

Secondary

MeasureTime frame
safety Measurement

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026