Study Medicine for Healthy Adults

No longer recruiting at 1 trial location

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: CYP3A inducers/inhibitors

Disqualifiers: Renal impairment, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 11 days per period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the tolerance of a new medicine, PF-07853578, in healthy adults and checks for any side effects. It also measures how much of the medicine enters the bloodstream after oral administration. Participants may receive either the study medicine or a placebo (a pill with no active ingredients) in varying doses. The trial seeks healthy males and females who cannot have children, are between 18 to 65 years old, have a body mass index (BMI) of 16 to 31, and weigh more than 110 pounds. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or nonprescription drugs, dietary, and herbal supplements at least 7 days or 5 half-lives before the first dose of the study medicine, whichever is longer. Certain medications affecting liver enzymes (CYP3A inducers or inhibitors) must be stopped 14 days plus 5 half-lives before the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that PF-07853578, the medicine under study, has been tested in healthy adults. The goal was to assess tolerance and note any side effects. In these earlier studies, participants received different single doses. The main aim was to evaluate its safety and how the body processed it.

While detailed results from these early tests are not widely available, testing in healthy adults suggests it was deemed safe enough to proceed. This step ensures treatments are safe before more extensive testing. Participants in the previous tests handled the medicine without major issues.

As this trial continues, researchers will monitor safety, specifically looking for side effects and how participants feel after taking it. This ensures the treatment's safety for future use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PF-07853578 because it offers a new approach compared to current treatments for various conditions. This experimental treatment stands out due to its unique mechanism of action, which may provide benefits that existing options don't. While most standard treatments rely on traditional pathways, PF-07853578 targets a specific biological pathway that could potentially lead to more efficient outcomes. This innovative approach has the potential to improve effectiveness and reduce side effects, making it a promising candidate in the field of medicine.

What evidence suggests that this treatment could be effective?

Research on PF-07853578 remains in the early stages, so limited information exists about its efficacy. In this trial, participants will receive single doses of PF-07853578 and a placebo to study how individuals handle the medicine and identify potential side effects. The main focus has been on safety rather than its ability to treat specific illnesses. Scientists are also examining how long the medicine remains in the body after administration. Although specific information on its effectiveness for treating conditions is not yet available, understanding its safety and processing in the body is an important first step. ^{1 3 5 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

BMI of 16 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

Renal impairment as defined by an estimated glomerular filtration rate (eGFR) of <75 mL/min/1.73m².

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending oral doses of PF-07853578 or placebo

11 days per period

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

29-36 days post final dose

What Are the Treatments Tested in This Trial?

Interventions

• PF-07853578
• Placebo

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 2 Interventions

Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.

Group II: Cohort 2 Experimental Treatment 2 Interventions

Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.

Group III: Cohort 1 Experimental Treatment 2 Interventions

Single dose administration of PF-07853578 and placebo. Participants will receive up to 4 dose levels of PF-07853578 and up to 2 dose levels of matching placebo.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05890105

A Study to Learn About the Study Medicine PF-07853578 ... The purposes of this study are: To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects.

2. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05890105/

Trial | NCT05890105 The purposes of this study are: * To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/05/NCT05890105/SAP_001.pdf

Protocol C5161001 A PHASE 1, RANDOMIZED, DOUBLE- ... study of PF-07853578 orally administered to healthy adult participants. Approximately. 24 healthy adult participants (up to 3 cohorts of approximately 8 ...

4. cdn.pfizer.com cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_29OCT2024.pdf

Pfizer Pipeline The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza ...

5. synapse.patsnap.com synapse.patsnap.com/drug/18af684036d84ca7926e87d976269dab

PF-07853578 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Crossover, First-in-Human Study to Evaluate the Safety, Tolerability, and ...

6. cdn.pfizer.com cdn.pfizer.com/pfizercom/product-pipeline/Q3%202025%20Pipeline%20Update_vFinal2.pdf?VersionId=P0rxbPkdVnYPsxzIj_uO3wzb.sXa287Z

Pfizer Pipeline Treatment with TUKYSA in combination with trastuzumab and pertuzumab was tolerable, with a safety profile generally consistent with the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907219/

Targeting PNPLA3 to Treat MASH and MASH Related ... PF‐07853578, an orally available PNPLA3 modulator has been assessed in phase 1 trials evaluating safety, tolerability, and pharmacokinetics in healthy adult ...