A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
Condition: Alzheimers Disease
MeSH terms: Alzheimer Disease
Intervention: RO7126209; Placebo
Intervention description: Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed.; Participants will be administered a single intravenous dose of matching placebo.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to
      investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending
      intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for
      the treatment of Alzheimer's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy status is defined by the absence of evidence of any active or chronic disease
             following a detailed medical and surgical history, a complete physical examination
             including vital signs, 12-lead ECG, ophthalmologic examination, hematology, blood
             chemistry, coagulation, serology, and urinalysis.

          -  Body mass index (BMI) of 18-30 kg/m2 inclusive

          -  During the treatment period and until the final follow up visit, agreement to: (1)
             Remain abstinent or use contraceptive measures such as a condom plus an additional
             contraceptive method that together result in a failure rate of <1% per year, with a
             partner who is a woman of childbearing potential. (2) With pregnant female partner,
             remain abstinent or use contraceptive measures such as a condom to avoid exposing the
             embryo. (3) Refrain from donating sperm from Day 1 of the study until 90 days after
             last dose.

        Exclusion Criteria:

          -  Concomitant disease or condition that could interfere with, or treatment of which
             might interfere with, the conduct of the study, or that would, in the opinion of the
             Investigator, pose an unacceptable risk to the participant in this study.

          -  History of any clinically significant gastrointestinal, renal, hepatic,
             broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological,
             ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or
             cirrhosis.

          -  Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of
             drug of abuse within the last 5 years.

          -  Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency
             virus (HIV) 1 and 2.

          -  History or presence of clinically significant ECG abnormalities or cardiovascular
             disease.

          -  Clinically-significant abnormalities in laboratory test results.

          -  Any major illness within one month before the screening examination or any febrile
             illness within one week prior to screening and up to first dose administration.

          -  Impaired hepatic function as indicated by screening aspartate aminotransferase (AST)
             or alanine aminotransferase (ALT) >=1.5 x the upper limit of normal (ULN) or abnormal
             total bilirubin unless due to Gilbert's disease.

          -  Any clinically relevant history of hypersensitivity or allergic reactions, either
             spontaneous or following drug administration, or exposure to foods or environmental
             agents.

          -  History of hypersensitivity to biologic agents or any of the excipients in the
             formulation.

          -  History of raised intra-cerebral pressure or vertebral joint pathology

          -  Use of prohibited medication or herbal remedies as described in the section of
             concomitant medications

          -  Prior administration of gantenerumab (RO4909832)

          -  Any vaccination within two months prior to Day 1

          -  Participation in an investigational drug medicinal product or medical device study
             within 30 days before screening or within seven times the elimination half-life if
             known, whichever is longer.

          -  Participants who regularly smoke more than 5 cigarettes daily or equivalent and are
             unable or unwilling not to smoke during the in-house period.

          -  Donation or loss of blood over 500 mL within three months prior to Day 1 and donation
             of blood for the duration of the study until follow-up.

          -  Evidence of clinically significant brain magnetic resonance imaging (MRI) findings,
             including lacunar infarct, territorial infarct or macroscopic hemorrhage, microbleed
             or area of leptomeningeal hemosiderosis, or deep white matter lesions corresponding to
             an overall Fazekas score of ≥ 2.

          -  Claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear
             implants, or foreign metal objects in the eyes, skin, or body that would
             contraindicate an MRI scan.