A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 31
- Locations
- 4
- Primary Endpoint
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.
Exclusion Criteria
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.
- •Women of childbearing potential.
- •History or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.
Time Frame: Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).
Time Frame: Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
Time Frame: Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.
Time Frame: Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.
Time Frame: From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.
Time Frame: Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).
Time Frame: Screening up to Day 168
Mean change from baseline and placebo in body temperature.
Time Frame: Screening up to Day 168
Secondary Outcomes
- Area under the concentration-time curve from zero to infinite time postdose (AUCinf).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Time to maximum concentration (Tmax).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Maximum concentration (Cmax).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Terminal elimination half-life (t½).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Clearance (CL).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)
- Volume of distribution (Vz).(Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168)