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

NCT ID: NCT02766621

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-27

Study Completion Date

2017-09-26

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.

Detailed Description

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Conditions

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Healthy

Keywords

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First in human, Phase 1, Healthy volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo injection SC/IV

Placebo for injection SC/IV

Group Type PLACEBO_COMPARATOR

Placebo injection SC/IV

Intervention Type DRUG

Comparison of Placebo to different doses of PF-06823859

PF-06823859

Study Drug being used in the study

Group Type ACTIVE_COMPARATOR

PF-06823859

Intervention Type BIOLOGICAL

Comparison of different dosages of PF-06823859 to placebo

Interventions

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PF-06823859

Comparison of different dosages of PF-06823859 to placebo

Intervention Type BIOLOGICAL

Placebo injection SC/IV

Comparison of Placebo to different doses of PF-06823859

Intervention Type DRUG

Other Intervention Names

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Study drug Placebo

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33352008 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C0251001&StudyName=Phase+1%2C+Randomized%2C+Double-blind%2C+Third-party+Open+Placebo-controlled%2C+Dose+Escalating+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+Pharmacokinetics+And+Pharmacodynamics+Of+Single+And+Multiple+Intravenous++And+Subcutaneous+Doses+Of+Pf-06823859+In+Healthy+Subjects

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

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C0251001&StudyName=Phase+1%2C+Randomized%2C+Double-blind%2C+Third-party+Open+Placebo-controlled%2C+Dose+Escalating+Study+To+Evaluate+The+Safety%2C+Tolerability%2C+Pharmacokinetics+And+Pharmacodynamics+Of+Single+And+Multiple+Intravenous+And+Subcutaneous+Doses+Of+Pf-06823859+In+Healthy+Subjects

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

Other Identifiers

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C0251001

Identifier Type: -

Identifier Source: org_study_id