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The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
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| 2 | Placebo Comparator |
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| 3 | Placebo Comparator |
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| 4 | Placebo Comparator |
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| 5 | Placebo Comparator | Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram |
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| 6 | Placebo Comparator |
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| 7 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06252616 | Biological | 1.0 milligram per kilogram of PF-06252616, IV infusion, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment related Adverse Events. | Day 197 | |
| Severity of treatment related Adverse Events. | Day 197 | |
| Incidence of abnormal lab findings. | Day 197 | |
| Magnitude of abnormal lab findings. | Day 197 | |
| Abnormal and clinically relevant changes in Blood Pressure. | Day 197 | |
| Abnormal and clinically relevant changes in Pulse Rate. | Day 197 | |
| Abnormal and clinically relevant changes in Respiratory Rate. | Day 197 | |
| Abnormal and clinically relevant changes in temperature. | Day 197 | |
| Abnormal and clinically relevant changes in ECG parameters. | Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration) | Through Day 197 post dosing | |
| Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay | Through Day 197 post dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36104012 | Derived | Wojciechowski J, Purohit VS, Harnisch LO, Dua P, Tan B, Nicholas T. Population PK and PD Analysis of Domagrozumab in Pediatric Patients with Duchenne Muscular Dystrophy. Clin Pharmacol Ther. 2022 Dec;112(6):1291-1302. doi: 10.1002/cpt.2747. Epub 2022 Oct 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C000634266 | domagrozumab |
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| Placebo |
| Drug |
Placebo for PF-06252616, IV infusion, single dose |
|
| PF-06252616 | Biological | 3.0 milligram per kilogram of PF-06252616, IV infusion, single dose |
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| Placebo | Drug | Placebo for PF-06252616, IV infusion, single dose |
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| PF-06252161 | Biological | 10.0 milligram per kilogram of PF-06252616, IV infusion, single dose |
|
| Placebo | Drug | Placebo for PF-06252616, IV infusion, single dose |
|
| PF-06252616 | Biological | 3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose |
|
| Placebo | Drug | Placebo for PF-06252616, Subcutaneous injection, single dose |
|
| PF-06252616 | Biological | 10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose |
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| Placebo | Drug | Placebo for PF-06252616, IV infusion, repeat dose |
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| PF-06252616 | Biological | 20.0 milligram per kilogram of PF-06252616, IV infusion, single dose |
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| Placebo | Drug | Placebo for PF-06252616, IV infusion, single dose |
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| PF-06252616 | Biological | 40.0 milligram per kilogram of PF-06252616, IV infusion, single dose |
|
| Placebo | Drug | Placebo for PF-06252616, IV infusion, single dose |
|
| Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay | Through Day 197 post dosing |
| Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA | Through Day 113 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half). | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for AUCĪ (area under the curve serum concentration by dose interval) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug. | Through Day 197 post dosing |
| Steady state volume of distribution is the apparent volume of distribution at steady-state.) | Through Day 197 post dosing |
| PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC) | Through Day 197 post dosing |