NCT06975774

Phase II Clinical Clical of the Pure Protein Derivatives of BCG

Randomized, Double-blind, Double-mal Injection, Control Study of Phase II Clinical Dose Calibration of BCG Pure Protein Derivative (BCG-PPD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial used randomized, double-blind, double-arm intradermal injection, and the same marketed products, selected 30 pulmonary tuberculosis patients aged 18-65 years who met the inclusion criteria and did not meet the exclusion criteria, and conducted the double-arm skin test using BCG-PPD and marketed BCG-PPD controls. During the screening period, the subjects underwent evidence collection of confirmed tuberculosis, physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest CT, HIV antibody test, and blood pregnancy examination of women of childbearing age; Vital signs examination before the skin test, The injection site was photographed 0min after the skin test, Vital signs were performed 30min after the skin test; Vital signs were examined, pictures of the injection site was taken, and the injection site reaction was measured; Observe the skin test response, Record the redness, hardening longitudinal diameter and transverse diameter and other related reactions; All adverse events within 72h after the skin test were recorded and safety evaluated.

Detailed description

Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Subjects who are eligible for screening receive the drug number in the order they arrive at the random number allocation room.During the screening period, tuberculosis diagnosis evidence collection, physical examination, vital signs, blood routine, urine routine test, blood biochemistry, electrocardiogram, chest CT, HIV antibody test and blood pregnancy examination of women of childbearing age were conducted; after screening, study number (drug number) was assigned, and double arm BCG-PPD skin test with 0.1ml injection. Vital signs should be taken before skin test, injection site photographed 0min and 30min after skin test; vital signs examined, injection site photographed and measured 48-72h after skin test; observe skin test reaction, record red, hard vertical diameter and transverse diameter and other related reactions of skin test; record all adverse events within 72h after skin test and perform safety evaluation.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	Purified Protein Derivative of BCG（BCG-PPD）	Thirty subjects were randomized, double-blinded to perform a homogeneous double-arm BCG-PPD skin test.

Timeline

• Start date: 2023-07-26
• Primary completion: 2023-12-31
• Completion: 2024-01-15
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: China