12 Participants NeededMy employer runs this trial

Tilrekimig + rHuPH20 for Healthy Subjects

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body processes a new treatment called tilrekimig when combined with rHuPH20. rHuPH20 enhances the absorption of some medicines when injected under the skin. Individuals who are generally healthy, can adhere to the study schedule, and weigh over 110 pounds may qualify. Those with serious medical conditions or past allergic reactions to certain treatments should not participate. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that tilrekimig is safe for patients, causing few problems and demonstrating safety similar to a placebo, a harmless pill used in tests. Common side effects included infections and skin issues, but they were not serious.

The other treatment in this study, rHuPH20, is already approved for use with other medicines. It has been tested and found safe for aiding the absorption of medicines when injected under the skin. Together, these treatments have demonstrated positive safety results in past research.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of tilrekimig and rHuPH20 because it introduces a novel approach to drug delivery. Unlike traditional treatments that might rely on separate administration, this combination utilizes rHuPH20 to enhance the dispersion and absorption of tilrekimig. This potentially allows for more efficient and rapid action of the drug. Additionally, tilrekimig may offer a new mechanism of action by targeting different pathways compared to existing treatments, which could lead to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective?

Research has shown that recombinant human hyaluronidase PH20 (rHuPH20) helps certain medicines absorb more effectively when injected under the skin by breaking down a substance in the body that can slow drug absorption. Studies have found that this process allows medicines to enter the system more quickly and work better. In this trial, participants will receive a single dose of co-mixed tilrekimig and rHuPH20. Currently, there is limited information on tilrekimig's effectiveness in humans. However, it is being investigated as a new treatment, and using it with rHuPH20 might improve its delivery and effectiveness. The goal of combining them is to leverage rHuPH20's ability to enhance drug absorption.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and able to safely receive injections under the skin.

Inclusion Criteria

I am able to understand and sign the consent form.
BMI of 16-32 kg/m2 and total body weight greater than 50 kg (110 lb)
Participants willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures

Exclusion Criteria

Evidence or history of any clinically significant medical condition
I have a history of HIV, hepatitis B, or hepatitis C infection.
I have an active, past, or untreated tuberculosis infection.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of co-mixed tilrekimig and rHuPH20

Single dose
1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics after the single dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • rHuPH20
  • Tilrekimig

Trial Overview

The study is testing how a single dose of tilrekimig behaves in the body when given together with rHuPH20, which helps medicines get absorbed better when injected under the skin. Both are given as one-time shots.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: tilrekimig and rHuPH20Experimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Pfizer's Phase 2 Study of Trispecific Antibody Positive in ...

Tilrekimig was well-tolerated with a favorable safety profile and no dose dependent safety signals; adverse event (AE) rates were comparable to ...

Pfizer Phase II Data Supports Once-Monthly Trispecific ...

tilrekimig was well-tolerated across all doses, with adverse events comparable to placebo. Common adverse events included infections, skin and ...

Pfizer's Phase 2 Study of Trispecific Antibody Tilrekimig ...

Tilrekimig was well-tolerated with a favorable safety profile and no dose dependent safety signals; adverse event (AE) rates were comparable to ...

AD Pipeline Watch: Tilrekimig, a Trispecific Antibody, Hits ...

Tilrekimig was well-tolerated with a favorable safety profile and no dose-dependent safety signals; adverse event (AE) rates were comparable to placebo.

Pfizer's trispecific heads to Phase III on mid-stage AD ...

Rates of treatment-emergent adverse events (TEAEs) across the tilrekimig cohorts were also comparable to placebo, with patients given the drug ...