Healthy
Conditions
Keywords
First in human, Phase 1, Healthy volunteers
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.
Interventions
BIOLOGICALPF-06823859
Comparison of different dosages of PF-06823859 to placebo
DRUGPlacebo injection SC/IV
Comparison of Placebo to different doses of PF-06823859
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion criteria
1. History of active or latent tuberculosis (TB) regardless of treatment; positive Quantiferon - TB test. 2. Subjects with a history of autoimmune disorders. 3. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs | Dosing through approximately Day 189 | Safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau (dose normalized) | Pre dose to approximately Day 189 | Pharmacokinetics |
| C av 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 |
| Apparent Clearance (CL) 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 |
| Volume of Distribution at Steady State (Vss) 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 |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] 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 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously | Pre dose to approximately Day 189 | Pharmacokinetics |
| 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 End of Dosing Interval (AUCtau) of PF-06823859 | Pre dose to approximately Day 189 | Pharmacokinetics |
Countries
United States
Outcome results
None listed