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RO7806881 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RO7806881: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will receive single doses of RO7806881, at 8 dose levels across 9 different cohorts (A1-A9) including one optional SAD cohort of East Asian participants (Cohort A9). |
| Placebo: SAD | PLACEBO_COMPARATOR | Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881. |
| RO7806881: Multiple Ascending Doses (MAD) | EXPERIMENTAL | Participants will receive multiple doses of RO7806881, at 4 dose levels across 4 different cohorts (B1-B4), per the predefined dosing regimen. |
| Placebo: MAD | PLACEBO_COMPARATOR | Participants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen. |
| Name | Type | Description |
|---|---|---|
| RO7806881 | DRUG | RO7806881 will be administered as per the schedule specified in the protocol. |
| Placebo | DRUG | Placebo will be administered as per the schedule specified in the protocol. |
Inclusion Criteria: * Participants must be males or females who are overtly healthy as determined by medical evaluation * Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (...
RO7806881 is an investigational small molecule drug being developed by Roche Holding AG. It is currently in Phase 1 clinical development, with a single active trial evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants. No therapeutic indication has been disclosed for this asset.
RO7806881 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sole sponsor of the Phase 1 study listed for this compound.
RO7806881 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency, and it remains an investigational agent. One Phase 1 trial is currently recruiting, and no trials have been completed.
RO7806881 is being studied in NCT07271693, titled A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants. The trial is a recruiting Phase 1 study with an estimated enrollment of 128 healthy volunteers, conducted in New Zealand.
The Phase 1 trial of RO7806881, NCT07271693, is a randomized, double-blind, placebo-controlled study enrolling 128 healthy volunteers aged 18 years and older of all sexes. It is being conducted in New Zealand and is currently recruiting participants.