Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DSTA4637S · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| DSTA4637S low dose level + SOC | EXPERIMENTAL | DSTA4637S low dose level intravenous (IV) infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| DSTA4637S intermediate dose level+ SOC | EXPERIMENTAL | DSTA4637S intermediate dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| DSTA4637S high dose level+ SOC | EXPERIMENTAL | DSTA4637S high dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| Placebo + SOC | PLACEBO_COMPARATOR | Placebo matched to DSTA4637S IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics. |
| DSTA4637S | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DSTA4637S | DRUG | DSTA4637S will be administered as an IV infusion at 3 dose levels. |
| Placebo | DRUG | Placebo matched to DSTA4637S IV infusion will be administered as specified. |
| SOC | DRUG | Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines. |
Inclusion Criteria: * Body mass index greater than or equal (\>/=) 18 to less than or equal to (\</=) 40 kg/m\^2 * At randomization, participants must have \>/=1 blood culture or molecular diagnostic that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120 hours * In the...
DSTA4637S is an investigational small molecule being studied for use in healthy volunteers and in patients with Staphylococcus aureus bacteremia. It is being developed by Roche Holding AG (RHHBY) for the infectious disease therapeutic area. The drug is currently in Phase 1 clinical development and is not yet approved.
DSTA4637S is a small molecule being developed by Roche Holding AG (RHHBY) for infectious disease. It is being studied in healthy volunteers and in patients with Staphylococcus aureus bacteremia. The drug is in Phase 1 clinical trials, and its specific molecular target has not been disclosed.
DSTA4637S is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule for infectious disease, currently in Phase 1 clinical development. It is being studied for use in healthy volunteers and in patients with Staphylococcus aureus bacteremia.
DSTA4637S is in Phase 1 clinical development. It is an investigational small molecule being developed by Roche Holding AG (RHHBY) for infectious disease. The drug is not yet approved and is being studied in healthy volunteers and in patients with Staphylococcus aureus bacteremia.
DSTA4637S has been studied in two completed Phase 1 clinical trials. NCT02596399 investigated safety, tolerability, and pharmacokinetics in healthy volunteers. NCT03162250 investigated safety, tolerability, and pharmacokinetics in participants with Staphylococcus aureus bacteremia receiving standard-of-care antibiotics. Both trials are completed.