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A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects

NCT ID: NCT00991159

Last Updated: 2012-07-04

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.

Detailed Description

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Conditions

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Healthy

Keywords

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Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RN316

Group Type EXPERIMENTAL

RN316

Intervention Type BIOLOGICAL

Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.

Interventions

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RN316

Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive.
* Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl.
* BMI 18.5 to 35, and body weight ≤150 kg, inclusive.

Exclusion Criteria

* Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results.
* Secondary hyperlipidemia.
* Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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 Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Miami Gardens, Florida, United States

Site Status

Countries

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United States

References

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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.

Reference Type DERIVED
PMID: 37994400 (View on PubMed)

Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.

Reference Type DERIVED
PMID: 28181260 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1481001&StudyName=A%20Study%20To%20Access%20The%20Safety%20And%20Tolerability%20Of%20RN316%20%28PF-04950615%29%20When%20Administered%20To%20Healthy%20Adult%20Subjects

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

Other Identifiers

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RN316-101

Identifier Type: -

Identifier Source: secondary_id

B1481001

Identifier Type: -

Identifier Source: org_study_id