Clinical trial NCT02766621: Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: First in human, Phase 1, Healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-05-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs
timeFrame: Dosing through approximately Day 189
Secondary outcomes:
measure: Apparent Clearance (CL) of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Maximum Observed Plasma Concentration (Cmax) of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Pre dose to approximately Day 189
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06823859 administered subcutaneously
timeFrame: Pre dose to approximately Day 189
measure: Volume of Distribution at Steady State (Vss) of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: AUCtau (dose normalized)
timeFrame: Pre dose to approximately Day 189
measure: C av of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Mean residence of time for PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: Maximum Observed Plasma Concentration (Cmax) dose normalized of PF-06823859
timeFrame: Pre dose to approximately Day 189
measure: bioavailability of PF-06823859 subcutaneous doses compared to intravenous doses of PF-06823859
timeFrame: Pre dose to approximately Day 189
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Neelakantan S, Oemar B, Johnson K, Rath N, Salganik M, Berman G, Pelletier K, Cox L, Page K, Messing D, Tarabar S. Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon beta Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study. Clin Pharmacol Drug Dev. 2021 Mar;10(3):307-316. doi: 10.1002/cpdd.887. Epub 2020 Dec 22.