Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–55
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Healthy lactating females who are actively breast-feeding or expressing breast milk, at least 12 weeks post-partum and not currently pregnant between 18 and 55 years old
Body Mass Index (BMI): 17.5 kg/m2; and a total body weight \>50 kg (110 lb)
Infants of women enrolled in the study must be able to feed successfully from a bottle or other age-appropriate alternative feeding method prior to the start of the study and must be able to tolerate infant formula if the mother does not have a supply of stored breast milk sufficient to cover the duration of the study
Participants must be willing to temporarily discontinue breast feeding their infants for a total of 4.5 days (108 hours)
Participants must be willing to regularly pump breasts throughout the study and express milk according to a schedule designed to maintain lactation throughout the study period
You may not be if
Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of screening or Day -1
Evidence or history of clinically significant findings
History of febrile illness or mastitis within 5 days prior to the first dose of study medication
Participants who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
Abnormal vital signs such as blood pressure, 12-lead electrocardiogram
History of alcohol abuse and/or illicit drug use, tobacco use in excess of 5 cigarettes/day or 2 chews/day
