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Healthy ParticipantPhase 1NCT07235137

A Study to Learn How the Study Medicine Called Ibuzatrelvir is Taken up Into the Blood in Healthy Chinese Adults

A Phase 1 study testing Ibuzatrelvir in people with Healthy Participant, run by Pfizer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study to learn how the study medicine called Ibuzatrelvir is taken up into the blood in healthy Chinese adults. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Participant
What is being tested?
Ibuzatrelvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
16 Oct 2025to 21 Nov 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female participants aged from 18 years old or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
  • BMI of 16-32 kg/m2 (both inclusive); and a total body weight >45 kg (99 lbs.).
  • Chinese male and female participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
  • Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
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  • A positive urine drug test. A single repeat for positive drug screen may be allowed.
  • Pregnant or breastfeeding women.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times, and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (e.g., QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST segment and/or T wave changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmia or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs with abnormal findings should be overread by a physician experienced in reading ECGs before excluding a participant.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: ALT, AST, Bilirubin ≥1.5× ULN

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

Other trials in China

About this study

Official title: A Phase 1, Single Arm Study to Evaluate the Pharmacokinetics Following Single Dose of PF-07817883 (Ibuzatrelvir) in Healthy Chinese Adult Participants.

A study to learn how the study medicine called Ibuzatrelvir is taken up into the blood in healthy Chinese adults.

Read the detailed description

To evaluate the PK profile of ibuzatrelvir after administration in Chinese healthy participants

Being tested
Ibuzatrelvir
Keywords
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), coronavirus disease 2019 (COVID-19)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbuzatrelvirDrug

    Also called PF-07817883

    Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers

Study groups in NCT07235137
Study groupRoleWhat they receive
IbuzatrelvirExperimentalIbuzatrelvir will be given by mouth to adult Chinese healthy volunteers
Receives: Drug: Ibuzatrelvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax)

    Measured: up to Day 3

  2. AUCinf

    Measured: up to Day 3

  3. Terminal phase half-life (t½)

    Measured: up to Day 3

Secondary outcomes (4)

  1. Adverse events and severe adverse events

    Measured: up to Day 3

  2. Incidence of abnormal and clinically relevant changes in vital signs

    Measured: up to Day 3

  3. Incidence of abnormal and clinically relevant changes in electrocardiogram

    Measured: Up to Day 3

  4. Incidence of abnormal and clinically relevant changes in laboratory assessments

    Measured: Up to Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start16 Oct 2025
  3. Primary completion21 Nov 2025
  4. Study completion21 Nov 2025

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235137
Sponsor's protocol ID
C5091002
Status last verified
Jan 2026
First submitted
14 Nov 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibuzatrelvir in people with Healthy Participant, run by Pfizer at 1 site in China.

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 3 inclusion and 11 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: finished, as of the sponsor's last update on 7 Jan 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Observed Plasma Concentration (Cmax) (time frame: up to Day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07235137.

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 7 Jan 2026.

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