NCT02766621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

May 27, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

May 6, 2016

Last Update Submit

November 13, 2017

Conditions

Healthy

Keywords

First in human, Phase 1, Healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs

    Safety

    Dosing through approximately Day 189

Secondary Outcomes (14)

  • Apparent Clearance (CL) of PF-06823859

    Pre dose to approximately Day 189

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-06823859

    Pre dose to approximately Day 189

  • Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06823859

    Pre dose to approximately Day 189

  • Number of Participants With Anti-Drug Antibody (ADA) to PF-06823859

    Pre dose to approximately Day 189

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of PF-06823859

    Pre dose to approximately Day 189

  • +9 more secondary outcomes

Study Arms (2)

Placebo injection SC/IV

PLACEBO COMPARATOR

Placebo for injection SC/IV

Drug: Placebo injection SC/IV

PF-06823859

ACTIVE COMPARATOR

Study Drug being used in the study

Biological: PF-06823859

Interventions

PF-06823859BIOLOGICAL

Comparison of different dosages of PF-06823859 to placebo

Also known as: Study drug
PF-06823859
Placebo injection SC/IVDRUG

Comparison of Placebo to different doses of PF-06823859

Also known as: Placebo
Placebo injection SC/IV

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 33352008DERIVED

Related Links

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

May 27, 2016

Primary Completion

August 30, 2017

Study Completion

September 26, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

US(1)