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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004493-18 | EudraCT Number | ||
| FIH SAD/MAD | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06730512 | Experimental | Study Drug being used in the study |
|
| Placebo | Placebo Comparator | Placebo for IV/SC administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06730512 | Biological | Comparison of different dosages of PF-06730512 to Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s) | Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s) | 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) | 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 | 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 | 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 | Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-06730512 | Maximum Observed Plasma Concentration (Cmax) of PF-06730512 | Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) |
| Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512 |
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Inclusion Criteria:
Exclusion Criteria:
- 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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34369667 | Derived | 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. |
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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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| ID | Term |
|---|---|
| C000722615 | PF-06730512 |
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| Placebo |
| Drug |
Comparison of Placebo to different doses of PF-06730512 |
|
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512 |
| 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 | 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 | 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 | 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 | Day 1 to approximately Day 113 |
| Apparent Volume of Distribution of PF-06730512, as permitted | Apparent Volume of Distribution of PF-06730512, as permitted | Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) |
| Terminal half-life, as permitted | Terminal half-life, as permitted | Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) |
| Accumulation ratio (Rac), as permitted | Accumulation ratio (Rac), as permitted | Day 1 to approximately Day 113 |
| Minimum observed concentration during the dosing interval (Cmin) | Minimum observed concentration during the dosing interval (Cmin) | 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) | Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose) |
| To obtain contact information for a study center near you, click here. | View source |