Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CMS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, RO7033877; Period 2, CMS; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment. |
| Treatment Sequence 2 | EXPERIMENTAL | Participants will be randomized to one of two treatment sequences. Sequence 2 is: Period 1, CMS; Period 2, RO7033877; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment. |
| Name | Type | Description |
|---|---|---|
| CMS | DRUG | Multiple doses of CMS over 2.5 days |
| RO7033877 | DRUG | Multiple doses of RO7033877 over 2.5 days |
| RO7033877 + CMS | DRUG | Multiple doses of RO7033877 and CMS over 2.5 days |
Inclusion Criteria: * Adult male or female (of non childbearing potential) healthy volunteers between 18 to 55 years * Body mass index (BMI) between 18 and 30 kg/m2 * Non smokers * Use adequate contraception methods Exclusion Criteria: * Evidence of active of chronic disease * Regular consumption...
CMS is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy volunteers, where it was given in combination with colistin methanesulfonate sodium to investigate a drug-drug interaction. CMS has not been approved by the FDA and remains in clinical development.
CMS is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche sponsored the Phase 1 drug-drug interaction study of CMS conducted in the Netherlands. No other developers are identified for this asset.
CMS is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The study enrolled 28 healthy volunteers and was a controlled, randomized design without blinding. CMS is investigational and has not been approved by the FDA.
CMS has been evaluated in one completed Phase 1 trial, NCT02156323. The study investigated the drug-drug interaction between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate sodium (CMS) in healthy volunteers. It enrolled 28 participants in the Netherlands and included adults aged 18 years and older of all sexes.
Yes, CMS is also known as RO7033877. The completed Phase 1 trial NCT02156323 refers to the drug as RO7033877 while studying its drug-drug interaction with colistin methanesulfonate sodium, which is also abbreviated CMS. Both names refer to the same Roche investigational small molecule.