HealthyPhase 1NCT07792941
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 study testing tilrekimig and rHuPH20 in people with Healthy, run by Pfizer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tilrekimig and rHuPH20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to 20 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Pfizer Clinical Research Unit (NH PCRU)
New Haven, Connecticut, 06511
About this study
Official 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
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.
- Conditions
- Healthy
- Being tested
- tilrekimig and rHuPH20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tilrekimig and rHuPH20Drug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| tilrekimig and rHuPH20 | Experimental | a single dose of co-mixed tilrekimig and rHuPH20 Receives: Drug: tilrekimig and rHuPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilrekimig area under the serum concentration-time curve from time zero to infinity (AUCinf)
Measured: 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)
Measured: 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
Measured: Baseline through day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start27 Aug 2026
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792941
- Sponsor's protocol ID
- C4531039
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07792941
- Acronym / sponsor ID
- C4531039
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tilrekimig and rHuPH20 | Experimental | Drug: tilrekimig and rHuPH20a single dose of co-mixed tilrekimig and rHuPH20 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tilrekimig and rHuPH20subcutaneous injection | Drug | tilrekimig and rHuPH20 |
Primary outcome
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
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
1 secondary outcome
Incidence of Treatment-emergent adverse events
Time frame: Baseline through day 150
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tilrekimig and rHuPH20 in people with Healthy, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.