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

NCT00991159 | Completed Phase 1

• 2 other identifiers: B1481001RN316-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects

  Entire duration of study

Secondary Outcomes (3)

• pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects

  Entire duration of study

• pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects

  Entire duration of study

• single dose immunogenicity

  Entire duration of study

Study Arms (1)

RN316

EXPERIMENTAL

Biological: RN316

Interventions

RN316 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.

RN316

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Phoenix, Arizona, 85013, United States

Location

Pfizer Investigational Site

Miami Gardens, Florida, 33169, United States

Location

Related Publications (2)

• 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.

  PMID: 37994400 DERIVED

• 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.

  PMID: 28181260 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias

Interventions

bococizumab

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 7, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

US (2)