Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Hypercholesterolemia; Dyslipidemia

Treatments: Biological: 4 mg/kg every 4 weeks; Biological: Placebo; Biological: 1 mg/kg every 2 weeks; Biological: 12 mg/kg every 8 weeks; Biological: 4 mg/kg every 8 weeks; Biological: 2 mg/kg every 4 weeks; Biological: 8 mg/kg every 8 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT01163838

B1481002

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo

RN316: 1 mg/kg every 2 weeks

Experimental group

Treatment:

Biological: 1 mg/kg every 2 weeks

RN316: 2 mg/kg every 4 weeks

Experimental group

Treatment:

Biological: 2 mg/kg every 4 weeks

RN316: 4 mg/kg every 4 weeks

Experimental group

Treatment:

Biological: 4 mg/kg every 4 weeks

RN316: 4 mg/kg every 8 weeks

Experimental group

Treatment:

Biological: 4 mg/kg every 8 weeks

RN316: 8 mg/kg every 8 weeks

Experimental group

Treatment:

Biological: 8 mg/kg every 8 weeks

RN316: 12 mg/kg every 8 weeks

Experimental group

Treatment:

Biological: 12 mg/kg every 8 weeks