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PF 06252616 · 1 trial · 1 indication
Adverse events include subject-reported symptoms as well as clinically-significant changes in laboratory testing, vital signs, and suicide screening (based on the Columbia Suicide Severity Rating Scale).
| Arm | Type | Description |
|---|---|---|
| Low Dose, Cohort 1 | ACTIVE_COMPARATOR | 4 subjects will be enrolled in cohort 1 and will receive an initial dose of 5mg/kg PF 06252616 IV every 4 weeks. Following 32 weeks of treatment and a safety review, if no stopping rules have been met, subjects will be receive an additional 32 weeks of treatment with 40 mg/kg PF 06252616 IV every 4 weeks. |
| Middle dose, Cohort 2 | ACTIVE_COMPARATOR | 8 subjects will be enrolled in cohort 2 and receive 20 mg/kg of PF 06252616 IV every 4 weeks for 32 weeks. |
| High dose, Cohort 3 | ACTIVE_COMPARATOR | 8 subjects will be enrolled in cohort 3 and receive 40 mg/kg of PF06252616 IV every 4 weeks for 32 weeks. |
| Name | Type | Description |
|---|---|---|
| PF 06252616 | DRUG | - |
Inclusion Criteria: 1. Male and female patients age ≥ 18 2. Diagnosis of LGMD2I as defined by clinical presentation consistent with LGMD2I and FKRP gene testing showing biallelic alterations known or likely to be pathogenic. Diagnosis must be confirmed in subject's medical history and by genetic te...
PF 06252616 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It has been studied in Phase 1 clinical trials for the treatment of LGMD2I, a form of limb-girdle muscular dystrophy, as well as in healthy volunteers. The drug is not approved and remains in clinical development.
PF 06252616 is being investigated for use in LGMD2I, a genetic muscle disorder, and has also been studied in healthy subjects to evaluate its safety and tolerability. It is an investigational drug and has not been approved for any indication.
PF 06252616 is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company has conducted clinical trials to evaluate the drug's safety and tolerability.
PF 06252616 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy subjects and one in participants with LGMD2I. The drug is investigational and has not received FDA approval.
PF 06252616 has been studied in two completed Phase 1 trials: NCT01616277, which evaluated safety and tolerability in healthy subjects, and NCT02841267, which assessed the drug in ambulatory participants with LGMD2I. Both trials were conducted in the United States.
Yes, PF 06252616 and PF-06252616 refer to the same investigational drug developed by Pfizer. The hyphenated version is the standard naming format used in clinical trial registries and scientific literature.