Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: PF-06823859Drug: Placebo injection SC/IV
- Registration Number
- NCT02766621
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF 06823859 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- Healthy female subjects of non childbearing potential and male subjects who, at the time of screening, are between the ages of 18 and 55 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 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test.
- Subjects with a history of autoimmune disorders.
- Subjects with a history of or positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-06823859 PF-06823859 Study Drug being used in the study Placebo injection SC/IV Placebo injection SC/IV Placebo for injection SC/IV
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs Dosing through approximately Day 189 Safety
- Secondary Outcome Measures
Name Time Method Apparent Clearance (CL) of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously Pre dose to approximately Day 189 Pharmacokinetics
Volume of Distribution at Steady State (Vss) of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
C av of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859 Pre dose to approximately Day 189 Immunogenicity
bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Maximum Observed Plasma Concentration (Cmax) of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Plasma Decay Half-Life (t1/2) Pre dose to approximately Day 189 Pharmacokinetics
AUCtau (dose normalized) Pre dose to approximately Day 189 Pharmacokinetics
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Mean residence of time for PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859 Pre dose to approximately Day 189 Pharmacokinetics
Trial Locations
- Locations (1)
Pfizer New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States