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RecruitingNCT07792941Updated Sep 4, 2026

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

A Phase 1 interventional study of tilrekimig and rHuPH20 in Healthy, sponsored by Pfizer. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    tilrekimig and rHuPH20

    a single dose of co-mixed tilrekimig and rHuPH20

    Drug: tilrekimig and rHuPH20

Interventions

  • Drugtilrekimig and rHuPH20

    subcutaneous injection

05

What researchers measure

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

06

Study locations

1 of 1 sites recruiting
  • New Haven Pfizer Clinical Research Unit (NH PCRU)
    New Haven, Connecticut 06511, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — 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.

08

Registry details

Key details

Study ID
NCT07792941
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Aug 27, 2026
Primary completion
Feb 11, 2027 (estimated)
Completion
Feb 11, 2027 (estimated)
Last update
Sep 4, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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