drugset / Trial / 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 1
Completed
60 enrolled
Chengdu CoenBiotech Co., Ltd
Beijing Chest Hospital, Capital Medical University · collabBeijing Friendship Hospital · collab
Non-randomizedSingle-groupOpen-labelDiagnostic
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).
Timeline
- Start
- 2023-01-17
- Primary completion
- 2023-05-09
- Completion
- 2023-05-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) | Protein / enzyme biologic | 2.5 ug/ml | Other |
| Subject | Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) | Protein / enzyme biologic | 5 ug/ml | Other |
| Subject | Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) | Protein / enzyme biologic | 10 ug/ml | Other |