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 being studied in healthy subjects. It has been evaluated in Phase 1 clinical trials to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. It is not approved for any medical condition and remains in clinical development.
HSD-016 is being developed by Pfizer, Inc. (NYSE: PFE). The company has sponsored Phase 1 clinical trials of this investigational small molecule in healthy volunteers.
HSD-016 is in Phase 1 clinical development. It has completed three Phase 1 trials, all of which were single or multiple ascending dose studies in healthy subjects. It is not FDA approved and remains investigational.
HSD-016 has completed three Phase 1 trials: NCT00739232 (single ascending dose study in the US, 74 participants), NCT00740649 (single ascending dose study in Japan, 74 male participants), and NCT00838461 (safety, PK, and PD study in the US, 32 participants). All trials enrolled healthy volunteers.
No alternative names for HSD-016 have been disclosed. It is identified solely by its code name HSD-016 in clinical trial registries and is distinct from other investigational agents.