Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01163838
• Other study ID #: B1481002
• Status: Withdrawn
• Phase: Phase 1
• First received: July 14, 2010
• Last updated: April 21, 2015
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• LDL-C must be greater or equal to 130 mg/dl

• BMI must be between 18.5 and 40 kg/m2

Exclusion Criteria:

• History of cardiovascular or cerebrovascular event during the past year.

• Poorly controlled type 1 or type 2 diabetes mellitus

• Subjects who have taken lipid lowering therapies within the last 3 months of screening.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

Biological:
• Placebo
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
• 1 mg/kg every 2 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
• 2 mg/kg every 4 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
• 4 mg/kg every 4 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
• 4 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
• 8 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
• 12 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting or intolerable treatment related adverse events (AEs).		Every Scheduled Visit	Yes
Primary	Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).		Every Scheduled Visit	Yes
Primary	Incidence of abnormal and clinically relevant safety laboratories.		Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197	Yes
Primary	Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.		Every Scheduled Visit	Yes
Primary	Incidence of anti-drug-antibodies.		Baseline and Day 15 and monthly thereafter	Yes
Secondary	PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316.		Day 1 and every scheduled visit thereafter	No
Secondary	Absolute and percentage change in LDL C from baseline.		Every scheduled visit except Day 1	No
Secondary	Proportion of subjects who achieve a target LDL C of <100 mg/mL.		Every scheduled visit except Day 1	No
Secondary	Proportion of subjects who achieve a target LDL C of <70 mg/dL.		Every scheduled visit except Day 1	No
Secondary	Proportion of subjects achieving 50% decrease in LDL C from baseline.		Every scheduled visit except Day 1	No

External Links

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