HealthyPhase 1NCT01740609
A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
A Phase 1 study testing PF-06342674 Dose A, PF-06342674 Dose B and PF-06342674 Dose C in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06342674 Dose A, PF-06342674 Dose B and PF-06342674 Dose C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
- BMI between 18.5 to 32 kg/m2.
- Total body weight ≥40 kg and ≤120 kg.
Who cannot join
- Previous treatment with an antibody within 6 months prior to Day 1.
- Pregnant or nursing females; females of childbearing potential.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
- Conditions
- Healthy
- Being tested
- Placebo, PF-06342674 Dose A, PF-06342674 Dose B, PF-06342674 Dose C, PF-06342674 Dose D
- Keywords
- Phase 1, RN168, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
PF-06342674 Dose ABiological
Single SC Dose
PF-06342674 Dose BBiological
Single SC Dose
PF-06342674 Dose CBiological
Single SC Dose
PF-06342674 Dose DBiological
Single SC Dose
PF-06342674 Dose EBiological
Single SC Dose
PF-06342674 Dose FBiological
Single IV Dose
PF-06342674 Dose GBiological
Single SC Dose
PF-06342674 Dose HBiological
Single IV Dose
PF-06342674 Dose IBiological
Single SC Dose
PF-06342674 Dose JBiological
Single IV Dose
| Study group | Role | What they receive |
|---|---|---|
| 1. Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2.0 | Experimental | Not described Receives: Biological: PF-06342674 Dose A; Biological: PF-06342674 Dose B; Biological: PF-06342674 Dose C; Biological: PF-06342674 Dose D; Biological: PF-06342674 Dose E; Biological: PF-06342674 Dose F; Biological: PF-06342674 Dose G; Biological: PF-06342674 Dose H; Biological: PF-06342674 Dose I; Biological: PF-06342674 Dose J |
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 AEs
Measured: 60 days
Incidence of treatment emergent AEs
Measured: 60 days
Incidence of abnormal laboratory findings
Measured: 60 days
Changes from baseline in safety laboratory assessments
Measured: 60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
Measured: 60 days
Incidence of anti-drug-antibodies
Measured: 60 days
Severity of treatment emergent AEs
Measured: 60 days
Causal relationship of treatment emergent AEs
Measured: 60 days
Secondary outcomes (7)
Area under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: 60 days
Maximum Observed Plasma Concentration (Cmax)
Measured: 60 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 60 days
PK parameter estimates including T1/2.
Measured: 60 days
Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: 60 days
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 60 days
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT01740609
- Sponsor's protocol ID
- B4351001
- Status last verified
- Jun 2014
- First submitted
- 5 Nov 2012
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Escalating Doses Of Pf-06342674 (RN168) In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01740609
- Acronym / sponsor ID
- B4351001
- Conditions
- Healthy
- Keywords
- Phase 1, RN168, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Dec 2012 (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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| 2.0 | Experimental | Biological: PF-06342674 Dose A, Biological: PF-06342674 Dose B, Biological: PF-06342674 Dose C, Biological: PF-06342674 Dose D, Biological: PF-06342674 Dose E, Biological: PF-06342674 Dose F, Biological: PF-06342674 Dose G, Biological: PF-06342674 Dose H, Biological: PF-06342674 Dose I, Biological: PF-06342674 Dose J |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
- BMI between 18.5 to 32 kg/m2.
- Total body weight ≥40 kg and ≤120 kg.
Key exclusion criteria (3 listed)
- Previous treatment with an antibody within 6 months prior to Day 1.
- Pregnant or nursing females; females of childbearing potential.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
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 |
|---|---|---|
| PlaceboPlacebo | Drug | 1. Placebo |
| PF-06342674 Dose ASingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose BSingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose CSingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose DSingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose ESingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose FSingle IV Dose | Biological | 2.0 |
| PF-06342674 Dose GSingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose HSingle IV Dose | Biological | 2.0 |
| PF-06342674 Dose ISingle SC Dose | Biological | 2.0 |
| PF-06342674 Dose JSingle IV Dose | Biological | 2.0 |
Primary outcome
Incidence of dose limiting or intolerable treatment related AEs
Time frame: 60 days
Incidence of treatment emergent AEs
Time frame: 60 days
Incidence of abnormal laboratory findings
Time frame: 60 days
Changes from baseline in safety laboratory assessments
Time frame: 60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
Time frame: 60 days
Incidence of anti-drug-antibodies
Time frame: 60 days
Severity of treatment emergent AEs
Time frame: 60 days
Causal relationship of treatment emergent AEs
Time frame: 60 days
7 secondary outcomes
Area under the Concentration-Time Curve (AUC)
Time frame: 60 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 60 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 60 days
PK parameter estimates including T1/2.
Time frame: 60 days
Systemic Clearance (CL)
Time frame: 60 days
Apparent Oral Clearance (CL/F)
Time frame: 60 days
Apparent Volume of Distribution (Vz/F)
Time frame: 60 days
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 19 Jun 2014.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06342674 Dose A, PF-06342674 Dose B and PF-06342674 Dose C in people with Healthy, run by Pfizer at 1 site 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 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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?
Incidence of dose limiting or intolerable treatment related AEs (time frame: 60 days). The study lists 8 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 19 Jun 2014.