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RO7105705

Phase 1

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Jul 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

RO7105705 · 1 trial · 1 indication

Phase 1 1
NCT02820896A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED74 Analytics
PHASE1COMPLETED
A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events
Screening up to Day 134
Number of Participants with Dose Limiting Adverse Events (DLAEs)
Day 1 up to Day 36
Change from Baseline in Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Baseline, up to approximately 134 days

Secondary Endpoints

Change From Baseline to Week 19 in Global Function as Assessed Using the Clinical Dementia Rating (CDR) Global Score in Alzheimer's Disease Participants
Baseline, Week 19
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Baseline, Days 29, 57, 113
Serum Concentration of RO7105705 - Single Dose Cohorts: IV Administration
Pre-dose, end of infusion (60-90 minutes), Hour 4, 8, 12 on Day 1, Days 2, 3, 8, 15, 29, 43, 57, 85, 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Multiple Dose Placebo IVPLACEBO_COMPARATORHealthy participants or participants with Alzheimer's disease will receive multiple doses of matching placebo IV QW, a total of 4 doses.
Multiple Dose RO7105705 IVEXPERIMENTALHealthy participants or participants with Alzheimer's disease will receive multiple doses of RO7105705 IV QW, a total of 4 doses.
Single Dose RO7105705 SCEXPERIMENTALHealthy participants will receive a single dose of RO7105705 SC on Day 1.
Single dose Placebo IVPLACEBO_COMPARATORHealthy participants will receive a single dose of placebo IV on Day 1.
Single dose RO7105705 IVEXPERIMENTALHealthy participants will receive a single dose of RO7105705 IV on Day 1.

Interventions

NameTypeDescription
PlaceboDRUGParticipants will receive single or multiple doses of RO7105705 matching placebo IV.
RO7105705DRUGParticipants will receive single or multiple doses of RO7105705 IV or SC.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All participants * Total body weight between 45 and 120 kilogram (kg), inclusive * Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug * In good health, determined by no clinically significa...

Countries:United States
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Frequently asked questions about RO7105705

What is RO7105705 used for?

RO7105705 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with mild-to-moderate Alzheimer's Disease, as well as in healthy participants.

Who makes RO7105705?

RO7105705 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule for Alzheimer's Disease. Roche is responsible for the drug's development program.

What phase is RO7105705 in?

RO7105705 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in healthy participants and participants with mild-to-moderate Alzheimer's Disease. The drug is investigational and has not been approved for any use.

What clinical trials is RO7105705 in?

RO7105705 has one completed clinical trial registered as NCT02820896, titled "A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease." This Phase 1 study enrolled 74 participants in the United States and was a randomized, double-blind, placebo-controlled trial.

Is RO7105705 FDA approved?

RO7105705 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer's Disease. The completed Phase 1 trial was designed to assess safety and tolerability, and further studies would be needed before any regulatory approval could be considered.