HealthyPhase 1NCT06965465
A Study to Learn How Different Amounts of the Study Medicine Called PF-07999415 Are Tolerated and Act in the Body in Healthy Adults
A Phase 1 study testing PF-07999415 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-07999415) in healthy adult participants. This study is seeking volunteers aged 18 to 65 years old who do not have any major health issues. 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-07999415
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jun 2025to 21 Aug 2026
- Phase
- Phase 1
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 and female participants of non-childbearing potential aged 18 to 65 years, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body Mass Index (BMI) of 18-33 kg/m2 and a total body weight >50 kg (110 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, dermatological, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- 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.
- Previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBOCONTROLLED, SINGLE DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF PF-07999415 IN HEALTHY ADULT PARTICIPANTS
The purpose of this clinical study is to learn about the safety and effects of the study medicine (called PF-07999415) in healthy adult participants.
This study is seeking volunteers aged 18 to 65 years old who do not have any major health issues.
Read more
Some participants in this study will receive a single dose of PF-07999415 as a shot in the thigh, abdomen, or arm at the study clinic. Afterward, participants will stay in a hospital-like setting for 2 weeks, where they will be monitored for reactions to the study medicine.
The study team will compare the experiences of people receiving PF-07999415 to those of the people who do not. This will help the study team decide if PF-07999415 is safe.
Participants will take part in this study for 3 to 7 months. During this time, participants will stay at the healthcare facility for 2 weeks and then come back for study visits every 2-4 weeks until completing the study.
- Conditions
- Healthy
- Being tested
- PF-07999415, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07999415Biological
Participants will receive single doses of PF-07999415.
PlaceboDrug
Participants will receive matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| PF-07999415 | Experimental | Not described Receives: Biological: PF-07999415 |
| Placebo | Placebo comparator | Not described Receives: 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.
Measured: First dose (Day 1) to up to final follow-up visit (Day 120)
Secondary outcomes (3)
Area under the concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) for PF-07999415
Measured: First dose (Day 1) to up to final follow-up visit (Day 120)
Maximum observed concentration (Cmax) for PF-07999415
Measured: First dose (Day 1) to up to final follow-up visit (Day 120)
Time to maximum observed concentration (Tmax) for PF-07999415
Measured: First dose (Day 1) to up to final follow-up visit (Day 120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start20 Jun 2025
- Primary completion21 Aug 2026
- Study completion21 Aug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 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
- NCT06965465
- Sponsor's protocol ID
- C5671001
- Other IDs
- 2024-520380-13-00
- Status last verified
- Oct 2026
- First submitted
- 2 May 2025
- Last updated
- 22 Oct 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.