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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06675188 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn if the study medicine (called PF-07275315) is safe and how it is processed in healthy Chinese participants. This study is seeking participants who:
All participants in this study will receive study medicine. About three-fourths will receive PF-07275315 and one-fourth will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The study medicine will be given as an IV infusion (directly into a vein) at the study clinic only one time.
The study will compare the experiences of people receiving PF-07275315 to those of people who do not. This will help see if PF-07275315 is safe and how it behaves inside the human body.
Participants will take part in this study for up to 181 days. During this time, the participants will stay at the study clinic for 5 days. After the stay, the participants will have 8 study visits at the study clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07275315 | Experimental | Participants will receive a single dose of PF-07275315 via IV infusion |
|
| Placebo | Placebo Comparator | Participants will receive a single dose of placebo via IV infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07275315 | Drug | PF-07275315 solution for injection (single use only) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Up to Day 181 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Up to Day 181 | |
| area under the concentration-time curve from time 0 to 336 hours (AUC336) | Up to Day 181 | |
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | Up to Day 181 | |
| Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast) | Up to Day 181 | |
| Terminal phase half-life (t½) | Up to Day 181 | |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to Day 181 | |
| Incidence of treatment-emergent serious adverse events (SAEs) | Up to Day 181 | |
| Incidence of abnormal and clinically relevant changes in vital signs | Up to Day 181 | |
| Incidence of abnormal and clinically relevant changes in electrocardiogram | Up to Day 181 | |
| Incidence of abnormal and clinically relevant changes in laboratory assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) of PF-07275315 | Up to Day 181 | |
| volume of distribution (Vss) | Up to Day 181 | |
| mean residence time (MRT) |
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Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | 201107 | China |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Placebo |
| Other |
Placebo solution for injection (single use only) |
|
| Up to Day 181 |
| Up to Day 181 |
| Incidence of the Development of Anti-Drug Antibodies (ADA) against PF-07275315 | Up to Day 181 |
| Incidence of the neutralizing antibodies (NAb) against PF-07275315, if appropriate and feasible | Up to Day 181 |
| Change from baseline in serum levels of chemokine (C-C motif) ligand 17 (CCL17) / thymus and activation regulated chemokine (TARC) | Up to Day 181 |
| Change from baseline in serum levels of total immunoglobulin E (IgE) | Up to Day 181 |