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RO6864018 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RO6864018 | EXPERIMENTAL | Asian participants will receive a single oral dose of RO6864018 capsule on Day 1. The first dose escalation cohort will receive a single 400 mg oral dose. Dose will be escalated in subsequent cohorts (up to Cohort 4) up to a maximum of 1600 mg, based on safety, pharmacokinetic, and pharmacodynamic data available from lower dose cohorts. The Cohort 5 will include Caucasian participants who will receive a single 1200 mg (or the highest dose well-tolerated by Asian participants, if lower than 1200 mg) oral dose of RO6864018 capsules on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single oral dose of placebo matching to RO6864018. |
| Name | Type | Description |
|---|---|---|
| RO6864018 | DRUG | A single oral ascending dose of RO6864018 capsules on Day 1. |
| Placebo | DRUG | A single oral dose of placebo matching RO6864018 capsules on Day 1. |
Inclusion Criteria: * Healthy male participants of ethnic Chinese, Korean, Japanese origin or Caucasian * No signs of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, ...
RO6864018 is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development. The drug has been studied in a completed trial involving healthy volunteers, with a focus on evaluating its safety, pharmacokinetics, and pharmacodynamics.
RO6864018 is being studied for use in healthy volunteers. The completed Phase 1 trial assessed the drug's safety, pharmacokinetics, and pharmacodynamics in this population. It is not approved for any medical condition and remains in clinical development.
RO6864018 is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.
RO6864018 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and the drug is not yet approved. It remains an investigational agent under study.
RO6864018 has one completed clinical trial, identified as NCT02015715. This Phase 1 study evaluated the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in male, healthy Asian participants in Singapore. The trial enrolled 48 participants and was placebo-controlled and double-blind.
RO6864018 is the sole name provided for this investigational drug. No alternative names have been associated with it in the available clinical trial information.