HypercholesterolemiaPhase 1NCT01163838
Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
A Phase 1 study testing 1 mg/kg every 2 weeks, 2 mg/kg every 4 weeks and 4 mg/kg every 4 weeks in people with Hypercholesterolemia and Dyslipidemia, run by Pfizer.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemia
- What is being tested?
- 1 mg/kg every 2 weeks, 2 mg/kg every 4 weeks and 4 mg/kg every 4 weeks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- LDL-C must be greater or equal to 130 mg/dl
- BMI must be between 18.5 and 40 kg/m2
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Being tested
- Placebo, 1 mg/kg every 2 weeks, 2 mg/kg every 4 weeks, 4 mg/kg every 4 weeks, 4 mg/kg every 8 weeks
- Keywords
- Hypercholesterolemia, Dyslipidemia, LDL, Cholesterol, High Cholesterol
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
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 weeksBiological
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 weeksBiological
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 weeksBiological
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 weeksBiological
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 weeksBiological
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 weeksBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| RN316: 1 mg/kg every 2 weeks | Experimental | Not described Receives: Biological: 1 mg/kg every 2 weeks |
| RN316: 2 mg/kg every 4 weeks | Experimental | Not described Receives: Biological: 2 mg/kg every 4 weeks |
| RN316: 4 mg/kg every 4 weeks | Experimental | Not described Receives: Biological: 4 mg/kg every 4 weeks |
| RN316: 4 mg/kg every 8 weeks | Experimental | Not described Receives: Biological: 4 mg/kg every 8 weeks |
| RN316: 8 mg/kg every 8 weeks | Experimental | Not described Receives: Biological: 8 mg/kg every 8 weeks |
| RN316: 12 mg/kg every 8 weeks | Experimental | Not described Receives: Biological: 12 mg/kg every 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting or intolerable treatment related adverse events (AEs).
Measured: Every Scheduled Visit
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
Measured: Every Scheduled Visit
Incidence of abnormal and clinically relevant safety laboratories.
Measured: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
Measured: Every Scheduled Visit
Incidence of anti-drug-antibodies.
Measured: 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.
Measured: Day 1 and every scheduled visit thereafter
Absolute and percentage change in LDL C from baseline.
Measured: Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <100 mg/mL.
Measured: Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <70 mg/dL.
Measured: Every scheduled visit except Day 1
Proportion of subjects achieving 50% decrease in LDL C from baseline.
Measured: Every scheduled visit except Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: Study was redesigned based on FDA feedback.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163838
- Sponsor's protocol ID
- B1481002
- Status last verified
- Apr 2015
- First submitted
- 14 Jul 2010
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01163838
- Acronym / sponsor ID
- B1481002
- Conditions
- Hypercholesterolemia, Dyslipidemia
- Keywords
- Hypercholesterolemia, Dyslipidemia, LDL, Cholesterol, High Cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was redesigned based on FDA feedback.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 16 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL-C must be greater or equal to 130 mg/dl
- BMI must be between 18.5 and 40 kg/m2
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects 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. | Biological | Placebo |
| 1 mg/kg every 2 weeksSubjects 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. | Biological | RN316: 1 mg/kg every 2 weeks |
| 2 mg/kg every 4 weeksSubjects 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. | Biological | RN316: 2 mg/kg every 4 weeks |
| 4 mg/kg every 4 weeksSubjects 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. | Biological | RN316: 4 mg/kg every 4 weeks |
| 4 mg/kg every 8 weeksSubjects 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. | Biological | RN316: 4 mg/kg every 8 weeks |
| 8 mg/kg every 8 weeksSubjects 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. | Biological | RN316: 8 mg/kg every 8 weeks |
| 12 mg/kg every 8 weeksSubjects 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. | Biological | RN316: 12 mg/kg every 8 weeks |
Primary outcome
Incidence of dose limiting or intolerable treatment related adverse events (AEs).
Time frame: Every Scheduled Visit
Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
Time frame: Every Scheduled Visit
Incidence of abnormal and clinically relevant safety laboratories.
Time frame: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197
Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
Time frame: Every Scheduled Visit
Incidence of anti-drug-antibodies.
Time frame: Baseline and Day 15 and monthly thereafter
5 secondary outcomes
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.
Time frame: Day 1 and every scheduled visit thereafter
Absolute and percentage change in LDL C from baseline.
Time frame: Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <100 mg/mL.
Time frame: Every scheduled visit except Day 1
Proportion of subjects who achieve a target LDL C of <70 mg/dL.
Time frame: Every scheduled visit except Day 1
Proportion of subjects achieving 50% decrease in LDL C from baseline.
Time frame: Every scheduled visit except Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 mg/kg every 2 weeks, 2 mg/kg every 4 weeks and 4 mg/kg every 4 weeks in people with Hypercholesterolemia and Dyslipidemia, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting or intolerable treatment related adverse events (AEs). (time frame: Every Scheduled Visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.