Phase I Study of RO7105705 in HV/AD patients

A Phase I Clinical Study of RO7105705 in Japanese Male Healthy Volunteers and Patients with Alzheimer's Disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224616

Enrollment

Registered

2019-03-27

Start date

2019-04-15

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

investigational material(s) Generic name etc : RO7105705 INN of investigational material : semorinemab Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Body weight between 40 kg and 100 kg, inclusive, at screening - Aged between 20 and 60 years, inclusive - Aged between 50 and 80 years, inclusive - Diagnosis of probable AD dementia based on National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria - Screening MMSE score of 16 to 28 points - Evidence of AD pathology as indicated by brain amyloid accumulation determined by quantitative determination of Abeta 42 concentration in CSF

Exclusion criteria

Exclusion criteria: - Prior treatment with any other anti-tau antibody - History or presence of a neurologic disease other than AD that may affect cognitive function - Abnormal findings on brain MRI at screening

Design outcomes

Primary

Measure	Time frame
safety Observation / Examination	—

Secondary

Measure	Time frame
other pharmacokinetics other (immunogenicity) Examination	—

Countries

Japan

Outcome results

None listed

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