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 drug developed by Pfizer, Inc. It has been studied in a Phase 1 clinical trial involving healthy adult volunteers. The study evaluated its safety, tolerability, and pharmacokinetics when administered orally. HKI-357 has not been approved by the FDA and remains in clinical development.
HKI-357 is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer sponsored the Phase 1 clinical trial of HKI-357 that evaluated the drug in healthy subjects. No other developer or partner is associated with HKI-357 based on its clinical development record.
HKI-357 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication. Its development stage remains early, with only a single completed study in healthy volunteers.
HKI-357 has been studied in one clinical trial, NCT00550381, titled "Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects." This Phase 1 trial was completed and enrolled 72 healthy adult volunteers. It was randomized, double-blind, and placebo-controlled.
The Phase 1 trial of HKI-357, NCT00550381, was a randomized, double-blind, placebo-controlled study conducted in healthy adult volunteers. It enrolled 72 participants aged 18 years and older, regardless of sex. The trial assessed the safety, tolerability, and pharmacokinetics of orally administered HKI-357 and has been completed.