Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RG7625 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Healthy volunteers will receive the placebo equivalent to RG7625 as oral capsules once or twice daily for 8 days. Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin purified protein derivative \[PPD\], Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. |
| RG7625 | EXPERIMENTAL | Participants will undergo a series of Screening visits prior to treatment and 7- to 14-day follow-up. Healthy volunteers will be enrolled in up to 4 cohorts and will receive RG7625 as oral capsules once or twice daily for 8 days. The first cohort is planned to receive 100 milligrams (mg) on Day 1, followed by 100 mg twice daily on Days 3 to 9. Subsequent dose and frequency decisions will be based upon observations in previous cohort(s). Each cohort will receive intradermal administration of 4 antigens (tetanus toxoid, tuberculin PPD, Candida albicans, and Trichophyton species) and a negative control at Screening and on Day 7 of treatment to assess for DTH. |
| Cohort A | EXPERIMENTAL | - |
| Cohort B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants will receive the placebo equivalent to RG7625 once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9. |
| RG7625 | DRUG | Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9. |
Inclusion Criteria: * Healthy adult males and females 18 to 60 years of age, inclusive * Body mass index 18.0 to 30.0 kilograms per meter-squared (kg/m\^2), inclusive Exclusion Criteria: * Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laborato...
RG7625 is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development, studied in healthy volunteers. Two Phase 1 trials have been completed, with a total enrollment of 50 participants. RG7625 is not approved and remains in clinical development.
RG7625 is being studied for use in healthy volunteers as part of early clinical development. The completed Phase 1 trials assessed the drug in healthy participants to evaluate its safety, tolerability, and pharmacokinetics. It is not approved for any specific disease or condition.
RG7625 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has conducted two Phase 1 clinical trials of RG7625 in healthy volunteers, both of which have been completed.
RG7625 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a single ascending-dose study and a multiple ascending-dose study, both in healthy volunteers. The drug is investigational and has not been approved.
RG7625 has been studied in two completed Phase 1 trials: NCT02295332, a study of RG7625 in healthy volunteers with 17 participants, and NCT02521610, a multiple ascending-dose study with 33 participants. Both trials were conducted in the Netherlands.
RG7625 is not known to be the same as any other drug. It is a distinct investigational small molecule developed by Roche Holding AG. No alternative names have been associated with RG7625 in the available clinical trial information.