You are here

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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85013 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00991159
Pfizer
Completed
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
NCT02743871
All Genders
18+
Years
Multiple Sites
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating, Intravenous Doses Of RN316 (PF-04950615) In Healthy Adult Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
Biological: 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.
Experimental: RN316
Intervention: Biological: RN316
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2010
May 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00991159
B1481001
RN316-101
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now