HealthyPhase 1NCT06686797
A Study to Learn How Different Amounts of the Study Medicine Called PF-08049820 Are Tolerated and Act in the Body in Healthy Adults
A Phase 1 study testing PF-08049820 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn about the safety of the study medicine called PF-08049820 in healthy adults. The study will also see: how the body processes the study medicine and if food affects the amount of study medicine in the blood. 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-08049820
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2024to 23 Feb 2026
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females who can no longer have children.
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.). Japanese participants only: a total body weight >45 kg is acceptable.
- Cohort 3 only:
- Have 4 biological Japanese grandparents who were born in Japan
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.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-08049820 IN HEALTHY ADULT PARTICIPANTS
The purpose of this study is to learn about the safety of the study medicine called PF-08049820 in healthy adults. The study will also see:
- how the body processes the study medicine and
- if food affects the amount of study medicine in the blood.
Read more
The study medicine is developed for the treatment of moderate to severe atopic dermatitis, also known as eczema. People with this condition may have severe itching and rashes on the skin.
The study is seeking participants who:
- Are males or females who can no longer have children,
- Are 18 to 65 years old,
- Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). For group or cohort 3 only:
- Have 4 biological Japanese grandparents who were born in Japan.
The study has three parts: Part A, Part B and Part C.
Part A consists of 3 groups (also known as "cohorts"). In Cohorts 1 and 2, there may be up to four dosing periods. During each dosing period, participants will take a single dose of the study medicine or placebo as liquid by mouth with or without food at the study clinic. A placebo does not have any medicine in it but looks just like the medicine being studied. The participants will stay at the study clinic for about 8 days and then can go home. During this time, the study team will observe the participants and take some urine and blood samples to test the level of the study medicine. The participants will return to the study clinic up to three more times to complete up to four dosing periods separated by at least 2 weeks. The participants will take increasing amounts of study medicine during each dosing period. After completion of the final dosing period, the participants will receive a follow-up telephone call about a month later. Cohort 3 consists of one dosing period and will enroll participants who have 4 biological Japanese grandparents who were born in Japan. Participants will be checked as described above and will receive a follow-up telephone call about one month after the last dose of study medicine or placebo.
Part B has 4 cohorts (Cohorts 4 to 7), each consisting of one dosing period. In all cohorts, participants will take multiple doses of the study medicine or placebo as tablets by mouth at the study clinic. Part C has two cohorts (Cohort 8 and 9), each consisting of one dosing period. In both cohorts, participants will take a single dose of the study medicine or placebo as tablets by mouth at the study clinic. Participants will be checked as described above and will receive a follow-up telephone call about one month after the last dose of study medicine or placebo.
- Conditions
- Healthy
- Being tested
- PF-08049820, Placebo
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08049820Drug
Oral solution/suspension for Part A (Cohorts 1 to 3). Tablets for Parts B and C (Cohorts 4 to 9).
PlaceboDrug
Oral solution/suspension for Part A (Cohorts 1 to 3). Tablets for Parts B and C (Cohorts 4 to 9).
| Study group | Role | What they receive |
|---|---|---|
| Part A: Cohort 1 | Experimental | Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo. Receives: Drug: PF-08049820; Drug: Placebo |
| Part A: Cohort 2 | Experimental | Up to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo. Receives: Drug: PF-08049820; Drug: Placebo |
| Part A: Cohort 3 | Experimental | One dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants. Receives: Drug: PF-08049820; Drug: Placebo |
| Part B: Cohort 4 | Experimental | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. Receives: Drug: PF-08049820; Drug: Placebo |
| Part B: Cohort 5 | Experimental | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. Receives: Drug: PF-08049820; Drug: Placebo |
| Part B: Cohort 6 | Experimental | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. Receives: Drug: PF-08049820; Drug: Placebo |
| Part B: Cohort 7 | Experimental | One dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. Receives: Drug: PF-08049820; Drug: Placebo |
| Part C: Cohort 8 | Experimental | One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants. Receives: Drug: PF-08049820; Drug: Placebo |
| Part C: Cohort 9 | Experimental | One dosing period with a single dose of PF-08049820 or placebo in healthy adult participants. Receives: Drug: PF-08049820; 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 (TEAEs)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B
Number of Participants With Serious Adverse Events (SAEs)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B
Secondary outcomes (9)
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Part A (Cohorts 1 to 3) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 8 of last dosing period for Parts A and C
Area under the curve from time zero to end of dosing interval (AUCtau)
Part B (Cohorts 4 to 7)
Measured: Baseline up to Day 13 for Part B
Maximum observed plasma concentration (Cmax)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Time to reach maximum observed plasma concentration (Tmax)
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Plasma decay half-life (t1/2) if data permit
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Measured: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Amount of unchanged drug recovered in urine during dosing interval (Aetau)
Part B (Cohorts 4 to 7)
Measured: Baseline up to Day 10 for Part B
Percent of dose recovered in urine as unchanged drug over dosing interval (Aetau%)
Part B (Cohorts 4 to 7)
Measured: Baseline up to Day 10 for Part B
Renal clearance (CLr)
Part B (Cohorts 4 to 7)
Measured: Baseline up to Day 10 for Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start27 Nov 2024
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
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
- 71 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
- NCT06686797
- Sponsor's protocol ID
- C6231001
- Other IDs
- NCT06686797
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2024
- Last updated
- 8 Sep 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED STUDY WITH DOUBLE-BLIND AND SPONSOR-OPEN, PLACEBO-CONTROLLED SINGLE- AND MULTIPLE-DOSE ESCALATION TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-08049820 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06686797
- Acronym / sponsor ID
- C6231001
- Conditions
- Healthy
- Keywords
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 13 Nov 2024 (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 of the study medicine called PF-08049820 in healthy adults. The study will also see:
- how the body processes the study medicine and
- if food affects the amount of study medicine in the blood.
The study medicine is developed for the treatment of moderate to severe atopic dermatitis, also known as eczema. People with this condition may have severe itching and rashes on the skin.
The study is seeking participants who:
- Are males or females who can no longer have children,
- Are 18 to 65 years old,
- Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). For group or cohort 3 only:
- Have 4 biological Japanese grandparents who were born in Japan.
The study has three parts: Part A, Part B and Part C.
Part A consists of 3 groups (also known as "cohorts"). In Cohorts 1 and 2, there may be up to four dosing periods. During each dosing period, participants will take a single dose of the study medicine or placebo as liquid by mouth with or without food at the study clinic. A placebo does not have any medicine in it but looks just like the medicine being studied. The participants will stay at the study clinic for about 8 days and then can go home. During this time, the study team will observe the participants and take some urine and blood samples to test the level of the study medicine. The participants will return to the study clinic up to three more times to complete up to four dosing periods separated by at least 2 weeks. The participants will take increasing amounts of study medicine during each dosing period. After completion of the final dosing period, the participants will receive a follow-up telephone call about a month later. Cohort 3 consists of one dosing period and will enroll participants who have 4 biological Japanese grandparents who were born in Japan. Participants will be checked as described above and will receive a follow-up telephone call about one month after the last dose of study medicine or placebo.
Part B has 4 cohorts (Cohorts 4 to 7), each consisting of one dosing period. In all cohorts, participants will take multiple doses of the study medicine or placebo as tablets by mouth at the study clinic. Part C has two cohorts (Cohort 8 and 9), each consisting of one dosing period. In both cohorts, participants will take a single dose of the study medicine or placebo as tablets by mouth at the study clinic. Participants will be checked as described above and will receive a follow-up telephone call about one month after the last dose of study medicine or placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 | Experimental | Drug: PF-08049820, Drug: PlaceboUp to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo. |
| Part A: Cohort 2 | Experimental | Drug: PF-08049820, Drug: PlaceboUp to 4 dosing periods in healthy adult participants. Each period consists of a single dose of PF-08049820 or placebo. |
| Part A: Cohort 3 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with a single dose of PF-08049820 or placebo in healthy adult Japanese participants. |
| Part B: Cohort 4 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part B: Cohort 5 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part B: Cohort 6 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part B: Cohort 7 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with multiple doses of PF-08049820 or placebo in healthy adult participants. |
| Part C: Cohort 8 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with a single dose of PF-08049820 or placebo in healthy adult participants. |
| Part C: Cohort 9 | Experimental | Drug: PF-08049820, Drug: PlaceboOne dosing period with a single dose of PF-08049820 or placebo in healthy adult participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy males and females who can no longer have children.
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.). Japanese participants only: a total body weight >45 kg is acceptable.
- Have 4 biological Japanese grandparents who were born in Japan
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.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
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-08049820Oral solution/suspension for Part A (Cohorts 1 to 3). Tablets for Parts B and C (Cohorts 4 to 9). | Drug | Part A: Cohort 1, Part A: Cohort 2, Part A: Cohort 3, Part B: Cohort 4, Part B: Cohort 5, Part B: Cohort 6, Part B: Cohort 7, Part C: Cohort 8, Part C: Cohort 9 |
| PlaceboOral solution/suspension for Part A (Cohorts 1 to 3). Tablets for Parts B and C (Cohorts 4 to 9). | Drug | Part A: Cohort 1, Part A: Cohort 2, Part A: Cohort 3, Part B: Cohort 4, Part B: Cohort 5, Part B: Cohort 6, Part B: Cohort 7, Part C: Cohort 8, Part C: Cohort 9 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline up to Day 21 of last dosing period for Parts A and C and up to Day 31 for Part B
Part A (Cohorts 1 to 3) Part B (Cohorts 4 to 7) Part C (Cohorts 8 and 9)
9 secondary outcomes
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Baseline up to Day 8 of last dosing period for Parts A and C
Area under the curve from time zero to end of dosing interval (AUCtau)
Time frame: Baseline up to Day 13 for Part B
Maximum observed plasma concentration (Cmax)
Time frame: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Time frame: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Plasma decay half-life (t1/2) if data permit
Time frame: Baseline up to Day 8 of last dosing period for Parts A and C and up to Day 13 for Part B
Amount of unchanged drug recovered in urine during dosing interval (Aetau)
Time frame: Baseline up to Day 10 for Part B
Percent of dose recovered in urine as unchanged drug over dosing interval (Aetau%)
Time frame: Baseline up to Day 10 for Part B
Renal clearance (CLr)
Time frame: Baseline up to Day 10 for Part B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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 PF-08049820 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 4 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: finished, as of the sponsor's last update on 8 Sep 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?
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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 35 of last dosing period for Parts A and C and up to Day 45 for Part B). The study lists 5 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 8 Sep 2026.