Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859

Study Overview
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Brief Summary
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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.

Official Title
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Phase 1, Randomized, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous And Subcutaneous Doses Of Pf-06823859 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Biological: PF-06823859
* Drug: Placebo injection SC/IV


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo injection SC/IV<br>Placebo for injection SC/IV | Drug: Placebo injection SC/IV<br>* Comparison of Placebo to different doses of PF-06823859<br>* Other names: Placebo;|
| Active Comparator: PF-06823859<br>Study Drug being used in the study | Biological: PF-06823859<br>* Comparison of different dosages of PF-06823859 to placebo<br>* Other names: Study drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs | Safety | Dosing through approximately Day 189 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apparent Clearance (CL) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859 | Immunogenicity | Pre dose to approximately Day 189 | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Maximum Observed Plasma Concentration (Cmax) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Plasma Decay Half-Life (t1/2) | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Volume of Distribution at Steady State (Vss) of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| AUCtau (dose normalized) | Pharmacokinetics | Pre dose to approximately Day 189 | 
| C av of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Mean residence of time for PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 
| bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859 | Pharmacokinetics | Pre dose to approximately Day 189 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First in human, Phase 1, Healthy volunteers