HealthyPhase 1NCT00991159
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
A Phase 1 study testing RN316 in people with Healthy, run by Pfizer at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RN316
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to May 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Miami Gardens, Florida, 33169
Pfizer Investigational Site
Phoenix, Arizona, 85013
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- RN316
- Keywords
- Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN316Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| RN316 | Experimental | Not described Receives: Biological: RN316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects
Measured: Entire duration of study
Secondary outcomes (3)
pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects
Measured: Entire duration of study
pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects
Measured: Entire duration of study
single dose immunogenicity
Measured: Entire duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT00991159
- Sponsor's protocol ID
- B1481001
- Other IDs
- RN316-101
- Status last verified
- Jul 2012
- First submitted
- 5 Oct 2009
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
PubMed 37994400Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
PubMed 28181260
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. 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 Single, Escalating, Intravenous Doses Of RN316 (PF-04950615) In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00991159
- Acronym / sponsor ID
- B1481001
- Conditions
- Healthy
- Keywords
- Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Oct 2009 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RN316 | Experimental | Biological: RN316 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| RN316Single, 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. | Biological | RN316 |
Primary outcome
Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects
Time frame: Entire duration of study
3 secondary outcomes
pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects
Time frame: Entire duration of study
pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects
Time frame: Entire duration of study
single dose immunogenicity
Time frame: Entire duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
- Derived from this study: PubMed 37994400Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
- Derived from this study: PubMed 28181260Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RN316 in people with Healthy, run by Pfizer at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects (time frame: Entire duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991159, which also lists 2 linked publications.
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 4 Jul 2012.