💬In plain words
What the trial is, and whether it could suit you
The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.
For Parts A, B, C, D and F, the study is seeking participants who:
* Are healthy (do not have disease) 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 body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight
For Part A (optional group or cohort 3: Japanese participants only):
* A body weight of more than 45 kilograms (100 pounds).
* Have 4 biological Japanese grandparents who were born in Japan.
For Part E only:
* Adults with a documented history of asth
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Key Inclusion criteria (Parts A, B, C, D and F):
1. Are males or females who can no longer have children,
2. Are 18 to 65 years old,
3. 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 Part A (Optional group or cohort 3: Japanese participants only):
1. A total body weight of more than 45 kg (100 pounds).
2. Have 4 biological Japanese grandparents who were born in Japan.
For Part E only:
1. Adults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.
2. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).
Key Exclusion criteria
1. Evidence or history of clinically significant medical conditions.
2. 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).
3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
5. Any history of parasitic infection requiring treatment within 28 days prior to screening.
6. Positive tuberculosis infection test result.
7. Part C only: Evidence or history of conditions interfering with the ability to taste.
8. Part D only: History of irregular bowel movements.
9. Part E only: Evidence of lung disease(s) other than asthma.
10. Part E only: Asthma exacerbation within 3 months prior to screening.
11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.
💊
What it tests
- PF-08103402
- Placebo
- Midazolam
Pfizer Clinical Research Unit - New Haven
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky