Phase I Study of RO7105705 in HV/AD patients

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2019
INTERVENTION: Intervention name : RO7105705 INN of the intervention : ‐ Dosage And administration of the intervention : < Male healthy volunteers >Single dose of RO7105705 or placebo will be administered by IV infusion. < Patients with AD >A total of 4 doses of RO7105705 or placebo will be administered by IV infusion over 8 weeks, with the first 3 doses administered at 2‐week intervals and the 4th dose administered 4 weeks after the 3rd dose. Control intervention name : ‐ INN of the control intervention : ‐ Dosage And administration of the control intervention : ‐ CONDITION: Alzheimer's disease PRIMARY OUTCOME: safety; Observation / Examination SECONDARY OUTCOME: pharmacokinetics, other; other (immunogenicity); Examination INCLUSION CRITERIA: < Male HV and Patients with AD > ‐ Body weight between 40 kg and 100 kg, inclusive, at screening < Male HV only > ‐ Aged between 20 and 60 years, inclusive < Patients with AD only > ‐ 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
Epistemonikos ID: bccde05d91a29ead6a0dda9b8407a0037e5d5c29
First added on: Aug 24, 2024