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 - Trial NCT06224608

Timeline & Enrollment

Primary Outcome

Incidence of adverse events (AEs) at the skin test site and non-skin test site within 28 days after skin testing, with particular attention to the incidence of AEs within 7 days after skin testing.,Incidence of abnormal blood routine, blood biochemistry, urine routine, and electrocardiogram detection indexes on the 3rd day after skin testing.,Incidence of abnormal vital signs within 7 days after skin testing.,Incidence of serious adverse events (SAEs) within 28 days after skin testing.

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).

ICD-10 Classifications