What is the mechanism of action of this treatment?

The clinical trial for PF-07275315 aims to assess the safety and tolerability of the drug in healthy subjects through intravenous infusions. Treatments like PF-07275315 often work by targeting specific biological pathways to modulate physiological responses without causing harm. For healthy subjects, understanding these mechanisms is crucial as it ensures that the drug does not induce adverse effects and maintains overall health. This knowledge helps in determining safe dosage levels and potential side effects, which is essential for the development of safe and effective medications.

What side effects are associated with this type of intervention?

In clinical trials involving treatments similar to PF-07275315, which are administered via intravenous infusion, common side effects often include local injection site reactions such as erythema, pain, or bruising. Other frequently reported adverse events can include fatigue, dizziness, and gastrointestinal issues like diarrhea. Serious adverse effects are generally uncommon, but hypersensitivity reactions such as rash and urticaria have been noted. Overall, these treatments are typically well-tolerated with most side effects being mild to moderate in intensity.

What prior FDA approvals exist?

The FDA has approved various drugs after evaluating their safety and tolerability in healthy subjects through clinical trials. These trials typically involve administering the drug or a placebo to healthy participants to monitor adverse effects and overall safety. For example, drugs like sildenafil have undergone such evaluations, where different doses were tested to determine their safety profile before being approved for specific conditions. Similarly, the trial for PF-07275315 aims to assess its safety and tolerability in healthy individuals, following a well-established process for ensuring that new drugs are safe for broader clinical use.

What other types of research exist?

Promising alternatives to PF-07275315 for healthy subjects include MYL-1401O, a trastuzumab biosimilar, which has shown similar pharmacokinetics and safety profiles to EU-trastuzumab and US-trastuzumab without serious adverse events. Additionally, new tyrosine kinase inhibitors targeting vascular endothelial growth factor receptors are under investigation, although their optimal dosing and long-term safety are still being studied.

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PF-07275315 in Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a body mass index (BMI) of 17.5 to 32 kg/m2 and a total body weight >50 kg (110 lb)

Be older than 18 years old

Must not have

Participants with any acute or chronic infections or infection history

Participants with evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) and history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-561 days

Summary

This trial tests a new medicine called PF-07275315 in healthy adults to see if it is safe. The medicine is given in increasing amounts to observe its effects.

Who is the study for?

Healthy individuals who have a BMI of 17.5 to 32 and weigh over 110 pounds can join this study. They must be free from significant recent trauma, major surgeries, TB, HIV, hepatitis B or C, and cannot have current or past malignancies except for certain skin cancers or cervical carcinoma in situ.

What is being tested?

The trial is testing PF-07275315's safety and effects compared to a placebo in healthy people. Participants will receive either the drug or placebo through an IV infusion across different groups with increasing doses deemed safe by the sponsor.

What are the potential side effects?

Since PF-07275315 is being tested for the first time in humans, potential side effects are unknown but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My BMI is between 17.5 and 32, and I weigh more than 110 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of infections or currently have an infection.

Select...

I do not have active TB, HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-561 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-561 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-561 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with Adverse Events (AEs)

Number of participants with Serious AEs (SAEs)

Number of participants with clinically meaningful change from baseline in ECG parameters

+2 more

Secondary study objectives

AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours

Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time

Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

PF-07275315

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-07275315

2022

Completed Phase 1

~70

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The clinical trial for PF-07275315 aims to assess the safety and tolerability of the drug in healthy subjects through intravenous infusions. Treatments like PF-07275315 often work by targeting specific biological pathways to modulate physiological responses without causing harm. For healthy subjects, understanding these mechanisms is crucial as it ensures that the drug does not induce adverse effects and maintains overall health. This knowledge helps in determining safe dosage levels and potential side effects, which is essential for the development of safe and effective medications.

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