A Study to Learn About the Single Dose Pharmacokinetics of Study Medicine Called Tilrekimig in Healthy Adults When Co-Mixed With rHuPH20
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
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Aug 2026
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2026
CompletedStudy Start
First participant enrolled
August 27, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 11, 2027
August 28, 2026
August 1, 2026
6 months
August 25, 2026
August 25, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Tilrekimig area under the serum concentration-time curve from time zero to infinity (AUCinf)
pre-dose, hours 12, 24, 48, 72, and 96 hours post dose. Days 8, 15, 30, 45, 60, 90, 120, and 150 post -dose
Tilrekimig Maximum Observed Plasma Concentration (Cmax)
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
Baseline through day 150
Study Arms (1)
tilrekimig and rHuPH20
EXPERIMENTALa single dose of co-mixed tilrekimig and rHuPH20
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
New Haven Pfizer Clinical Research Unit (NH PCRU)
New Haven, Connecticut, 06511, United States
Related Links
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2026
First Posted
August 28, 2026
Study Start
August 27, 2026
Primary Completion (Estimated)
February 11, 2027
Study Completion (Estimated)
February 11, 2027
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
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.