Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANX-188 Therapeutic Dose · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ANX-188 Therapeutic dose level | EXPERIMENTAL | IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours |
| ANX-188 Supratherapeutic dose | EXPERIMENTAL | IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours |
| Saline | PLACEBO_COMPARATOR | IV administration. Six hour infusion. |
| Moxifloxacin | ACTIVE_COMPARATOR | Oral tablet. 400 mg. |
| Name | Type | Description |
|---|---|---|
| ANX-188 Therapeutic Dose | DRUG | - |
| ANX-188 Supratherapeutic dose | DRUG | - |
| Saline | DRUG | - |
| Moxifloxacin | DRUG | - |
Inclusion Criteria: * Healthy male and female subjects aged 18 to 65 (inclusive) in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory testing at screening. Exclusion Criteria: * Participation in a clinical trial within the last...
ANX-188 Therapeutic Dose is an investigational small molecule being developed by Savara, Inc. (SVRA). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic dose is being evaluated for safety and tolerability.
ANX-188 Therapeutic Dose is being studied for use in healthy volunteers as part of early clinical development. The drug is intended to be evaluated for safety and pharmacological effects, though its specific therapeutic indication has not been disclosed in the available information.
ANX-188 Therapeutic Dose is being developed by Savara, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVRA. Savara is responsible for the clinical development and regulatory strategy for this investigational small molecule.
ANX-188 Therapeutic Dose is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a thorough QT/QTc study in healthy volunteers. The drug remains investigational and has not been approved by regulatory authorities.
ANX-188 Therapeutic Dose has been studied in one completed Phase 1 clinical trial, NCT01790087, titled 'ANX-188 Thorough QT/QTc Study in Healthy Volunteers.' This trial enrolled 72 healthy participants in the United States and was a randomized, double-blind, placebo-controlled study.
ANX-188 Therapeutic Dose is a formulation or dosing regimen of the investigational drug ANX-188. The clinical trial NCT01790087 refers to the drug as ANX-188, and the Therapeutic Dose designation indicates the specific dose level being evaluated in that study.