Phase I Clinical Protocol of BCG-PPD in Healthy People
Status:
Enrolling by invitation
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
A total of 80 healthy people aged 65 years and below who are randomly assigned to the
experimental group and the control group. The experimental group is injected with BCG-PPD
test drug once, and the control group is injected with BCG-PPD control drug once.Subjects
will undergo physical examination, vital signs, blood routine, urine routine, blood
biochemistry, electrocardiogram, HIV antibody test and blood pregnancy test for women of
childbearing age during the screening period.Vital signs were checked before skin test, the
injection site was photographed at 0min after skin test, and vital signs were checked at
30min after skin test.Vital signs examination, injection site photography and injection site
reaction measurement were performed 48h and 72h after skin test.Physical examination, vital
signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood
pregnancy test of women of childbearing age were performed again 7 days after skin test to
evaluate the safety of BCG-PPD.
Phase:
Phase 1
Details
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborators:
Beijing Kangterike Statistical Technology Co., Ltd. Neijiang Center for Disease Control and Prevention Sichuan Center for Disease Control and Prevention