Healthy
Conditions
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.
Interventions
subcutaneous injection
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of Treatment-emergent adverse events | Baseline through day 150 |
Countries
United States
Contacts
Pfizer