Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HSD-016 · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | HSD-016 |
| 2 | PLACEBO_COMPARATOR | placebo |
| Active | ACTIVE_COMPARATOR | Active |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| HSD-016 | DRUG | - |
| placebo | DRUG | - |
Inclusion criteria: 1. Men or women of nonchildbearing potential aged 18 to 50 years. 2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day. Exclusion c...
HSD-016 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in Phase 1 clinical trials involving healthy volunteers, and its specific therapeutic indication has not been disclosed. It is not described as an approved medicine.
HSD-016 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 clinical program for the compound, including the single ascending dose studies conducted in the United States and Japan.
HSD-016 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and no trials are currently active. The studies enrolled a total of 180 participants, all healthy volunteers, and the program has not advanced beyond this early stage.
HSD-016 has been evaluated in three completed Phase 1 trials: NCT00838461, which studied safety, pharmacokinetics, and pharmacodynamics in 32 healthy subjects in the United States; NCT00740649, a single ascending dose study in 74 healthy male subjects in Japan; and NCT00739232, a single ascending dose study in 74 healthy subjects in the United States.
The HSD-016 Phase 1 trials were randomized, double-blind, and placebo-controlled. They enrolled healthy volunteers, including a Japan-based study limited to male participants aged 20 years and older, and assessed safety, tolerability, pharmacokinetics, and pharmacodynamics. Total enrollment across the three completed studies was 180 participants.