Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept

NCT ID: NCT04543344

Last Updated: 2022-01-10

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-17

Study Completion Date

2021-11-26

Brief Summary

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This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Only cohort 1 of the study is blinded.

Study Groups

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Low Dose

Repeated multiple doses

Group Type EXPERIMENTAL

Recifercept

Intervention Type DRUG

recifercept powder for solution for injection

placebo

Repeated multiple doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

solution for injection

High Dose

Repeated multiple doses

Group Type EXPERIMENTAL

Recifercept

Intervention Type DRUG

recifercept powder for solution for injection

Interventions

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Recifercept

recifercept powder for solution for injection

Intervention Type DRUG

Placebo

solution for injection

Intervention Type OTHER

Other Intervention Names

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PF-07256472

Eligibility Criteria

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Inclusion Criteria

* Male participants and female participants of nonchildbearing potential
* Participants who are overtly healthy
* Capable of giving signed informed consent

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing
Minimum Eligible Age

21 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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Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, Belgium

Site Status

Countries

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Belgium

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4181004

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

Other Identifiers

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2020-000545-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C4181004

Identifier Type: -

Identifier Source: org_study_id

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