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OpenTrials
Not yet recruiting

NCT Number: NCT07792941

A Study to Learn About the Single Dose Pharmacokinetics of Study Medicine Called Tilrekimig in Healthy Adults When Co-Mixed With rHuPH20

This study aims to learn how the body handles tilrekimig when given with another medicine called recombinant human hyaluronidase PH20 (rHuPH20). rHuPH20 is approved to help some medicines be taken up by the body when they are given together as an injection (shot) under the skin.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Pfizer Clinical Research Unit (NH PCRU)

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Participants should be able to understand and sign informed consent

Exclusion criteria

  • Evidence or history of clinically significant any medical condition
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb or HCVAb.
  • Evidence of active, latent, or inadequately treated infection with Mycobacterium TB
  • History of allergic or anaphylactic reaction with any biologic agents.

Treatment and study plan

tilrekimig and rHuPH20

Drug

subcutaneous injection

Primary outcomes

  1. Tilrekimig area under the serum concentration-time curve from time zero to infinity (AUCinf)

    Time frame: pre-dose, hours 12, 24, 48, 72, and 96 hours post dose. Days 8, 15, 30, 45, 60, 90, 120, and 150 post -dose

  2. Tilrekimig Maximum Observed Plasma Concentration (Cmax)

    Time frame: pre-dose, hours 12, 24, 48, 72, and 96 hours post dose. Days 8, 15, 30, 45, 60, 90, 120, and 150 post dose

Secondary outcomes

  1. Incidence of Treatment-emergent adverse events

    Time frame: Baseline through day 150

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A RANDOMISED, PHASE 1, OPEN-LABEL, SINGLE-DOSE, STUDY TO EVALUATE THE PHARMACOKINETICS AND TOLERABILITY OF TILREKIMIG IN HEALTHY PARTICIPANTS WHEN CO-MIXED WITH RHUPH20 AS A SUBCUTANEOUS INJECTION

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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