NCT01163838|WithdrawnPhase 1

Study Stopped

Study was redesigned based on FDA feedback.

Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

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

Pfizer ClinicalTrials.gov

Compare

1 other identifier

B1481002

Study Type

interventional

Target

N/A

Locations

0 countries

Sites

N/A

Timeline

RegisteredJul 2010

StartedAug 2010

CompletionMar 2011

Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Aug 2010

Shorter than P25 for phase_1

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

First Submitted

Initial submission to the registry

July 14, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed

16 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed

Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

July 14, 2010

Last Update Submit

April 21, 2015

Conditions

Hypercholesterolemia Dyslipidemia

Keywords

HypercholesterolemiaDyslipidemiaLDLCholesterolHigh Cholesterol

Outcome Measures

Primary Outcomes (5)

Incidence of dose limiting or intolerable treatment related adverse events (AEs).
Every Scheduled Visit
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
Every Scheduled Visit
Incidence of abnormal and clinically relevant safety laboratories.
Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
Every Scheduled Visit
Incidence of anti-drug-antibodies.
Baseline and Day 15 and monthly thereafter

Secondary Outcomes (5)

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
Absolute and percentage change in LDL C from baseline.
Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <100 mg/mL.
Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <70 mg/dL.
Every scheduled visit except Day 1
Proportion of subjects achieving 50% decrease in LDL C from baseline.
Every scheduled visit except Day 1

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Biological: Placebo

RN316: 1 mg/kg every 2 weeks

EXPERIMENTAL

Biological: 1 mg/kg every 2 weeks

RN316: 2 mg/kg every 4 weeks

EXPERIMENTAL

Biological: 2 mg/kg every 4 weeks

RN316: 4 mg/kg every 4 weeks

EXPERIMENTAL

Biological: 4 mg/kg every 4 weeks

RN316: 4 mg/kg every 8 weeks

EXPERIMENTAL

Biological: 4 mg/kg every 8 weeks

RN316: 8 mg/kg every 8 weeks

EXPERIMENTAL

Biological: 8 mg/kg every 8 weeks

RN316: 12 mg/kg every 8 weeks

EXPERIMENTAL

Biological: 12 mg/kg every 8 weeks