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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo injection SC/IV; Biological: PF-06823859

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo injection SC/IV; Placebo for injection SC/IV	Drug: Placebo injection SC/IV; Comparison of Placebo to different doses of PF-06823859; Other Names: Placebo
ACTIVE_COMPARATOR: PF-06823859; Study Drug being used in the study	Biological: PF-06823859; Comparison of different dosages of PF-06823859 to placebo; Other Names: Study drug

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2016
• Primary Completion (ACTUAL): August 30, 2017
• Study Completion (ACTUAL): September 26, 2017

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (ESTIMATE): May 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: First in human, Phase 1, Healthy volunteers
• Other Study ID Numbers: C0251001