NCT06224608

Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis

Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chengdu CoenBiotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group. Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).

Detailed description

The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately for healthy subjects and pulmonary tuberculosis patients, with 20 participants in each dosage group. Enrollment will progress from low to high dosages, first with healthy subjects and then with pulmonary tuberculosis patients. The safety review committee (SRC) will review safety data before each dosage group escalates and before enrollment of tuberculosis patients. See the figure below for details. First, 10 healthy subjects will be enrolled in the low-dose group. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the medium-dose group (10 participants) will be enrolled. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the high-dose group (10 participants) will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm.After the last healthy subject in the low-dose group completes the 72-hour safety assessment following the skin test, pulmonary tuberculosis patients in the low-dose group can be enrolled simultaneously. Ten pulmonary tuberculosis patients will be enrolled in the low-dose group. After confirming the safety of the test drug within 72 hours of the skin test for all participants, the medium-dose group (10 participants) will be enrolled. After confirming the safety of the test drug within 72 hours of injection for all participants, the high-dose group (10 participants) will be enrolled. Participants will receive a single intradermal injection of 0.1 ml of the test drug using the Mantoux method on the volar aspect of the forearm. Within 28 days after the skin test of the test drug, observations were made of reactions at the skin test site, reactions at non-skin test sites, concomitant medication, and any other physical discomfort (skin test site-specific reactions were recorded separately).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)	1.0ml/bottle, containing 2.5μg/ml low dose, 5μg/ml medium dose, and 10μg/ml high dose of active ingredient. Take 0.1ml and inject it into the center of the front 1/3 of the palm side of the forearm by the Montessori method Single dose administration.

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-05-09
• Completion: 2023-05-09
• First posted: 2024-01-25
• Last updated: 2024-01-25

Locations

2 sites across 1 country: China