Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HKI-357 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | 10mg |
| 2 | PLACEBO_COMPARATOR | 20mg |
| 3 | PLACEBO_COMPARATOR | 40mg |
| 4 | PLACEBO_COMPARATOR | 80mg |
| 5 | PLACEBO_COMPARATOR | 160mg |
| 6 | PLACEBO_COMPARATOR | 240mg |
| 7 | PLACEBO_COMPARATOR | 400mg |
| 8 | PLACEBO_COMPARATOR | 640mg |
| 9 | PLACEBO_COMPARATOR | 960mg |
| 10 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| HKI-357 | DRUG | Single-dose capsule |
Eligibility Criteria: * Healthy adult men or women of nonchildbearing potential, aged 18-50.
HKI-357 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The only completed trial evaluated its safety, tolerability, and pharmacokinetics after oral administration in healthy subjects.
HKI-357 is being developed by Pfizer, Inc. (NYSE: PFE). The company sponsored a Phase 1 clinical trial to evaluate the drug's safety, tolerability, and pharmacokinetics in healthy subjects.
HKI-357 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
HKI-357 has one completed clinical trial, NCT00550381, titled "Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects." This Phase 1 trial enrolled 72 healthy volunteers and was placebo-controlled and double-blind.
No, HKI-357 is not FDA approved. It is an investigational drug in Phase 1 clinical development. The completed trial in healthy subjects was designed to assess safety, tolerability, and pharmacokinetics, not to support an approval application.
HKI-357 is a small molecule, but its molecular target has not been disclosed in the available clinical trial information. The completed Phase 1 study focused on safety, tolerability, and pharmacokinetics in healthy volunteers, without biomarker selection or target-specific endpoints.