HealthyPhase 1NCT03146065
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
A Phase 1 study testing PF-06730512 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF-06730512 in healthy subjects. 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-06730512
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2017to 3 May 2018
- 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
- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- History of allergic reactions to diagnostic or therapeutic protein. History of recurrent infections or active infection within 28 days of screening.
- Exposure to live vaccines within 28 days of screening.
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of subject vaccination is permissible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double Blind, Sponsor-open, Placebo-controlled, First-in-human Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06730512 After Single And Multiple Ascending Intravenous Infusion Or Subcutaneous Administration To Healthy Adult Subjects And An Open-label Evaluation In Healthy Japanese Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF-06730512 in healthy subjects.
- Conditions
- Healthy
- Being tested
- PF-06730512, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06730512Biological
Comparison of different dosages of PF-06730512 to Placebo
PlaceboDrug
Comparison of Placebo to different doses of PF-06730512
| Study group | Role | What they receive |
|---|---|---|
| PF-06730512 | Experimental | Study Drug being used in the study Receives: Biological: PF-06730512 |
| Placebo | Placebo comparator | Placebo for IV/SC administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Measured: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with injection site reaction(s)
Number of subjects with injection site reaction(s)
Measured: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with laboratory test findings of potential clinical importance
Number of subjects with laboratory test findings of potential clinical importance
Measured: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with vital signs findings of potential clinical importance
Number of subjects with vital signs findings of potential clinical importance
Measured: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with ECG findings of potential clinical importance
Number of subjects with ECG findings of potential clinical importance
Measured: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Secondary outcomes (11)
Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted
Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
Measured: Day 1 to approximately Day 113
Apparent Volume of Distribution of PF-06730512, as permitted
Apparent Volume of Distribution of PF-06730512, as permitted
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Terminal half-life, as permitted
Terminal half-life, as permitted
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Accumulation ratio (Rac), as permitted
Accumulation ratio (Rac), as permitted
Measured: Day 1 to approximately Day 113
Minimum observed concentration during the dosing interval (Cmin)
Minimum observed concentration during the dosing interval (Cmin)
Measured: Day 1 to approximately Day 113
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Measured: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start10 May 2017
- Primary completion3 May 2018
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 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
- NCT03146065
- Sponsor's protocol ID
- C0221001
- Other IDs
- 2016-004493-18, FIH SAD/MAD, 2016
- Status last verified
- May 2018
- First submitted
- 5 May 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Publications
Lim CN, Kantaridis C, Huyghe I, Gorman D, Berasi S, Sonnenberg GE. A Phase 1 first-in-human study of the safety, tolerability, and pharmacokinetics of the ROBO2 fusion protein PF-06730512 in healthy participants. Pharmacol Res Perspect. 2021 Aug;9(4):e00813. doi: 10.1002/prp2.813.
PubMed 34369667
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind, Sponsor-open, Placebo-controlled, First-in-human Trial To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf-06730512 After Single And Multiple Ascending Intravenous Infusion Or Subcutaneous Administration To Healthy Adult Subjects And An Open-label Evaluation In Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03146065
- Acronym / sponsor ID
- C0221001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 May 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 9 May 2017 (actual)
- 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 determine the safety, tolerability and pharmacokinetics of escalating single and multiple intravenous (IV) infusions and subcutaneous (SC) injections of PF-06730512 in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-06730512 | Experimental | Biological: PF-06730512Study Drug being used in the study |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for IV/SC administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure (BP) and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (3 listed)
- History of allergic reactions to diagnostic or therapeutic protein. History of recurrent infections or active infection within 28 days of screening.
- Exposure to live vaccines within 28 days of screening.
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of subject vaccination is permissible.
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 |
|---|---|---|
| PF-06730512Comparison of different dosages of PF-06730512 to Placebo | Biological | PF-06730512 |
| PlaceboComparison of Placebo to different doses of PF-06730512 | Drug | Placebo |
Primary outcome
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Number of subjects with injection site reaction(s)
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with injection site reaction(s)
Number of subjects with laboratory test findings of potential clinical importance
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with laboratory test findings of potential clinical importance
Number of subjects with vital signs findings of potential clinical importance
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with vital signs findings of potential clinical importance
Number of subjects with ECG findings of potential clinical importance
Time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with ECG findings of potential clinical importance
11 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] of PF-06730512, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Clearance (CL) or Apparent Clearance (CL/F) of PF-06730512, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06730512
Time frame: Day 1 to approximately Day 113
Apparent Volume of Distribution of PF-06730512, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Terminal half-life, as permitted
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Accumulation ratio (Rac), as permitted
Time frame: Day 1 to approximately Day 113
Minimum observed concentration during the dosing interval (Cmin)
Time frame: Day 1 to approximately Day 113
Incidence of the development of anti-drug antibody (ADA) and neutralizing antibody (NAb)
Time frame: Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
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 22 May 2018.
- Derived from this study: PubMed 34369667Lim CN, Kantaridis C, Huyghe I, Gorman D, Berasi S, Sonnenberg GE. A Phase 1 first-in-human study of the safety, tolerability, and pharmacokinetics of the ROBO2 fusion protein PF-06730512 in healthy participants. Pharmacol Res Perspect. 2021 Aug;9(4):e00813. doi: 10.1002/prp2.813.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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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-06730512 in people with Healthy, run by Pfizer at 1 site in Belgium.
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: finished, as of the sponsor's last update on 22 May 2018. 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 Belgium. 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?
Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s) (time frame: Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)). 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?
On the ClinicalTrials.gov record for NCT03146065, which also lists 1 linked publication.
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 22 May 2018.