Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7126209 · 2 trials · 1 indication
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Dose Finding) Cohort 1: Dose Level 1 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 1 once every 4 weeks (Q4W) for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 1 Q4W for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 2: Dose Level 2 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 2, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 3: Dose Level 3 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 4: Dose Level 4 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 4: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 5: Dose Level 5 of RO7126209 | EXPERIMENTAL | Participants will receive a total of 2 doses of RO7126209 at dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 1 (Dose Finding) Cohort 5: Placebo | PLACEBO_COMPARATOR | Participants will receive a total of 2 doses of matching placebo to dose level 5 Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 2 (Expansion) Cohort 1: Dose Level 3 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 3, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 2: Dose Level 4 of RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 at dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo to dose level 4, Q4W, for 28 weeks followed by a 28-week safety follow-up period. |
| Part 2 (Expansion) Cohort 3: Dose Level 5 of RO7126209 | EXPERIMENTAL | Participants will receive a total of 2 doses of RO7126209 at dose level 5, Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 2 (Expansion) Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants will receive a total of 2 doses of matching placebo to dose level 5, Q4W, for 28 weeks followed by an 8-week safety follow-up period. |
| Part 3 (Dose/Frequency/Pharmacodynamic (PD) Relationship): Dose Level 1: RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 1, Q4W, for 24 weeks followed by a 28-week safety follow-up period. |
| Part 3 Dose/Frequency/PD Relationship: Dose Level 2: RO7126209 | EXPERIMENTAL | Participants will receive multiple doses of RO7126209 in an open-label treatment period at dose level 2, Q12W, for 24 weeks followed by a 28-week safety follow-up period. |
| Part 4: Open Label Extension (OLE) | EXPERIMENTAL | Participants who completed Part 1, 2, or 3 will receive RO7126209 for a maximum of 205 weeks. |
| Placebo | PLACEBO_COMPARATOR | In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. |
| RO7126209 (0.1 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.1 mg/kg). |
| RO7126209 (0.4 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.4 mg/kg). |
| RO7126209 (1.2 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| RO7126209 (3.6 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| RO7126209 (7.2 mg/kg) | EXPERIMENTAL | Healthy volunteers will be administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
| Name | Type | Description |
|---|---|---|
| RO7126209 | DRUG | RO7126209 will be administered intravenously as specified in each treatment arm. |
| Placebo | DRUG | RO7126209-matching placebo will be administered intravenously as specified in each treatment arm. |
Key inclusion criteria for part 1, 2 and 3: * Ability to provide written consent signed by the participant * Availability of a person (referred to as the "study partner") who: consents to participate throughout the duration of study, in the Investigator's judgment, has frequent and sufficient conta...
RO7126209 is an investigational small molecule being developed by Roche Holding AG for the treatment of Alzheimer's disease. It is currently in Phase 1 clinical development, with studies evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants and in patients with prodromal or mild to moderate Alzheimer's disease.
RO7126209 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Alzheimer's disease, with studies taking place in multiple countries including the United States, Australia, Canada, Chile, Japan, Poland, South Korea, Spain, and the United Kingdom.
RO7126209 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in two Phase 1 trials: one completed single ascending dose study in healthy participants and one active multiple ascending dose study in patients with prodromal or mild to moderate Alzheimer's disease.
RO7126209 has two clinical trials. NCT04023994 is a completed Phase 1 single ascending dose study in healthy participants in the United States. NCT04639050 is an active Phase 1 multiple ascending dose study, known as Brainshuttle AD, in patients with prodromal or mild to moderate Alzheimer's disease across nine countries.
RO7126209 is the drug being tested in the Brainshuttle AD study, which is the title of the multiple ascending dose trial (NCT04639050). The study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7126209 following intravenous infusion in participants with prodromal or mild to moderate Alzheimer's disease.