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Phase I Clinical Protocol of BCG-PPD in Healthy People

NCT04593771 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-02-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BCG-PPD

BCG-PPD was used for skin test in 40 healthy people, and BCG-PPD was marketed in other 40 healthy people (as control)

Sponsors & Collaborators

  • Sichuan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Neijiang Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Beijing Kangterike Statistical Technology Co., Ltd.

    collaborator UNKNOWN

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ting Huang, Master · Sichuan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2021-05-24
Completion
2021-05-24

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04593771 on ClinicalTrials.gov