HealthyPhase 1NCT07235163
A Study to Learn How Different Amounts of the Study Medicine Called PF-08065010 Are Tolerated and Act in the Body of Healthy Adults
A Phase 1 study testing PF-08065010 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08065010) for possible treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). 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?
- PF-08065010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Apr 2026to 1 Sep 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
- male or female between 18 and 65 years of age
- deemed to be healthy
Who cannot join
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg)or hepatitis C antibody (HCVAb).
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- A positive urine drug test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: AN INTERVENTIONAL, PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE AND MULTIPLE DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF PF-08065010 IN HEALTHY ADULT PARTICIPANTS
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08065010) for possible treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
This study is seeking participants who are:
Read more
- male or female between 18 and 65 years of age
- deemed to be healthy
Participants in this study will receive PF-08065010 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-08065010 or placebo will be given as a shot (in the abdomen, thigh or back of the arms) or as an IV infusion in the arm (given directly into a vein) at the study clinic.
In Part A, participants will take PF-08065010 or placebo only 1 time and will take part in this study for about 5 months. During this time, they will stay at the study clinic for about 9-10 days and will have about 6 more study visits at the study clinic.
Participants in Part B of the study will take PF-08065010 or placebo once a month, for 3 months and will take part in this study for about 7 months. During this time, they will stay at the study clinic for about 4 days each month and will have about 6 more study visits at the study clinic.
During study clinic stays and study visits, urine, blood samples, and physical exams will be done.
- Conditions
- Healthy
- Being tested
- PF-08065010, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08065010Drug
Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV).
PlaceboDrug
Placebo which will be SC or IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 3: single ascending dose (SAD) | Experimental | Dose C - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 8: single ascending dose (SAD) | Experimental | Optional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 1: single ascending dose (SAD) | Experimental | Dose A - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 5: single ascending dose (SAD) | Experimental | Dose E - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 7: single ascending dose (SAD) | Experimental | Dose G - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 4: single ascending dose (SAD) | Experimental | Dose D - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 2: single ascending dose (SAD) | Experimental | Dose B - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 9: single ascending dose (SAD) | Experimental | Optional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 6: single ascending dose (SAD) | Experimental | Dose F - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 10: single ascending dose (SAD) | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part A: Cohort 11: single ascending dose (SAD) | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part B: Cohort 12: multiple dose | Experimental | Dose F - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part B: Cohort 13: multiple dose | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
| Part B: Cohort 14: multiple dose | Experimental | Optional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. Receives: Drug: PF-08065010; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part A
Measured: Baseline, approximately up to 5 months
Number of Participants With Clinically Significant Laboratory Abnormalities
Part A
Measured: Baseline, approximately up to 5 months
Number of Participants With Vital Sign Abnormalities
Part A
Measured: Baseline, approximately up to 5 months
Number of Participants with Change from Baseline in Physical Exam (PE) Parameters
Part A
Measured: Baseline, approximately up to 5 months
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Part A
Measured: Baseline, approximately up to 5 months
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part B
Measured: Baseline, approximately up to 7 months
Number of Participants With Clinically Significant Laboratory Abnormalities
Part B
Measured: Baseline, approximately up to 7 months
Number of Participants with Vital Sign Abnormalities
Part B
Measured: Baseline, approximately up to 7 months
Number of Participants with Change from Baseline in Physical Exam (PE) Parameters
Part B
Measured: Baseline, approximately up to 7 months
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Part B
Measured: Baseline, approximately up to 7 months
Secondary outcomes (9)
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Part A
Measured: Predose (Day 1), approximately up to 5 months
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)
Part A
Measured: Predose (Day 1), approximately up to 5 months
Maximum Observed Plasma Concentration (Cmax)
Part A
Measured: Predose (Day 1), approximately up to 5 months
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Part A
Measured: Predose (Day 1), approximately up to 5 months
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.
Part A
Measured: Predose (Day 1), approximately up to 5 months
Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau)
Part B
Measured: Predose (Day 1), approximately up to 7 months
Maximum Observed Plasma Concentration (Cmax)
Part B
Measured: Predose (Day 1), approximately up to 7 months
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Part B
Measured: Predose (Day 1), approximately up to 7 months
Plasma Decay Half-Life (t1/2)
Part B
Measured: Predose (Day 1), approximately up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start21 Apr 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
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
- NCT07235163
- Sponsor's protocol ID
- C6341001
- Other IDs
- 2025-523759-76-01, 2025
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 24 Aug 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN INTERVENTIONAL, PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE AND MULTIPLE DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF PF-08065010 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07235163
- Acronym / sponsor ID
- C6341001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Nov 2025 (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.
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08065010) for possible treatment of rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).
This study is seeking participants who are:
- male or female between 18 and 65 years of age
- deemed to be healthy
Participants in this study will receive PF-08065010 or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-08065010 or placebo will be given as a shot (in the abdomen, thigh or back of the arms) or as an IV infusion in the arm (given directly into a vein) at the study clinic.
In Part A, participants will take PF-08065010 or placebo only 1 time and will take part in this study for about 5 months. During this time, they will stay at the study clinic for about 9-10 days and will have about 6 more study visits at the study clinic.
Participants in Part B of the study will take PF-08065010 or placebo once a month, for 3 months and will take part in this study for about 7 months. During this time, they will stay at the study clinic for about 4 days each month and will have about 6 more study visits at the study clinic.
During study clinic stays and study visits, urine, blood samples, and physical exams will be done.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 3: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose C - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 8: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboOptional Japanese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 1: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose A - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 5: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose E - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 7: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose G - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 4: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose D - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 2: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose B - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 9: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboOptional Chinese Cohort dose to be determined - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 6: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboDose F - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 10: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
| Part A: Cohort 11: single ascending dose (SAD) | Experimental | Drug: PF-08065010, Drug: PlaceboOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
| Part B: Cohort 12: multiple dose | Experimental | Drug: PF-08065010, Drug: PlaceboDose F - Participants will receive PF-08065010 or placebo. |
| Part B: Cohort 13: multiple dose | Experimental | Drug: PF-08065010, Drug: PlaceboOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
| Part B: Cohort 14: multiple dose | Experimental | Drug: PF-08065010, Drug: PlaceboOptional Cohort with dose to be determined - Participants will receive PF-08065010 or placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female between 18 and 65 years of age
- deemed to be healthy
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg)or hepatitis C antibody (HCVAb).
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- A positive urine drug test.
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 |
|---|---|---|
| PF-08065010Experimental Pfizer compound which will be subcutaneous (SC) or intravenous (IV). | Drug | Part A: Cohort 10: single ascending dose (SAD), Part A: Cohort 11: single ascending dose (SAD), Part A: Cohort 1: single ascending dose (SAD), Part A: Cohort 2: single ascending dose (SAD), Part A: Cohort 3: single ascending dose (SAD), Part A: Cohort 4: single ascending dose (SAD), Part A: Cohort 5: single ascending dose (SAD), Part A: Cohort 6: single ascending dose (SAD), Part A: Cohort 7: single ascending dose (SAD), Part A: Cohort 8: single ascending dose (SAD), Part A: Cohort 9: single ascending dose (SAD), Part B: Cohort 12: multiple dose, Part B: Cohort 13: multiple dose, Part B: Cohort 14: multiple dose |
| PlaceboPlacebo which will be SC or IV | Drug | Part A: Cohort 10: single ascending dose (SAD), Part A: Cohort 11: single ascending dose (SAD), Part A: Cohort 1: single ascending dose (SAD), Part A: Cohort 2: single ascending dose (SAD), Part A: Cohort 3: single ascending dose (SAD), Part A: Cohort 4: single ascending dose (SAD), Part A: Cohort 5: single ascending dose (SAD), Part A: Cohort 6: single ascending dose (SAD), Part A: Cohort 7: single ascending dose (SAD), Part A: Cohort 8: single ascending dose (SAD), Part A: Cohort 9: single ascending dose (SAD), Part B: Cohort 12: multiple dose, Part B: Cohort 13: multiple dose, Part B: Cohort 14: multiple dose |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline, approximately up to 5 months
Part A
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline, approximately up to 5 months
Part A
Number of Participants With Vital Sign Abnormalities
Time frame: Baseline, approximately up to 5 months
Part A
Number of Participants with Change from Baseline in Physical Exam (PE) Parameters
Time frame: Baseline, approximately up to 5 months
Part A
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline, approximately up to 5 months
Part A
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline, approximately up to 7 months
Part B
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline, approximately up to 7 months
Part B
Number of Participants with Vital Sign Abnormalities
Time frame: Baseline, approximately up to 7 months
Part B
Number of Participants with Change from Baseline in Physical Exam (PE) Parameters
Time frame: Baseline, approximately up to 7 months
Part B
Number of Participants with Change from Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline, approximately up to 7 months
Part B
9 secondary outcomes
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Time frame: Predose (Day 1), approximately up to 5 months
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: Predose (Day 1), approximately up to 5 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose (Day 1), approximately up to 5 months
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Predose (Day 1), approximately up to 5 months
Plasma decay half-life (t1/2) is the time measured for the plasma concentration to decrease by one half.
Time frame: Predose (Day 1), approximately up to 5 months
Area under the serum concentration time profile over the dosing interval of 28 days (AUCtau)
Time frame: Predose (Day 1), approximately up to 7 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose (Day 1), approximately up to 7 months
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Predose (Day 1), approximately up to 7 months
Plasma Decay Half-Life (t1/2)
Time frame: Predose (Day 1), approximately up to 7 months
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 24 Aug 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.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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.
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 PF-08065010 in people with Healthy, run by Pfizer at 1 site in Belgium.
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: looking for participants now, as of the sponsor's last update on 24 Aug 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 Belgium. 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?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline, approximately up to 5 months). The study lists 10 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 24 Aug 2026.