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PF-05230905

Phase 1

Healthy | Small molecule | Other |Sanofi|Last Updated: Jan 31, 2013

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

PF-05230905 · 1 trial · 1 indication

Phase 1 1
NCT01284036A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy SubjectsHealthy
COMPLETED63 Analytics
PHASE1COMPLETED
A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
Healthy
NCT0128403663
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Study Endpoints

Primary Endpoints

Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.
day 168
Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.
day 168
Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects.
day 168

Secondary Endpoints

Incidence of development of Anti Drug Antibody.
day 168
Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters.
day 168
Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined.
day 168
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Study Design & Arms

AllocationNA
MaskingTRIPLE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
PF-05230905OTHER9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo

Interventions

NameTypeDescription
PF-05230905DRUGSingle dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Treatment with an investigational drug within 30 days (or as determined by the local requi...

Countries:United States
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Frequently asked questions about PF-05230905

What is PF-05230905?

PF-05230905 is an investigational small molecule being developed by Sanofi. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety and to measure investigational product levels in the blood.

What is PF-05230905 used for?

PF-05230905 is being studied for use in healthy subjects. The completed Phase 1 trial assessed the safety and investigational product level measurement of a single dose of the drug. It is not approved for any specific medical condition and remains in early clinical development.

Who makes PF-05230905?

Sanofi (ticker: SNY) is the developer of PF-05230905. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.

What phase is PF-05230905 in?

PF-05230905 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing early-stage clinical testing.

What clinical trials is PF-05230905 in?

PF-05230905 has one completed clinical trial, NCT01284036, titled "A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects." This Phase 1 study enrolled 63 healthy participants in the United States and was double-blind but uncontrolled.

Is PF-05230905 FDA approved?

PF-05230905 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial was a Phase 1 study in healthy subjects, and the drug has not yet progressed to later-stage trials or regulatory approval.