Who is sponsoring NCT06224608?

NCT06224608 is sponsored by Chengdu CoenBiotech Co., Ltd.

What condition does NCT06224608 study?

NCT06224608 studies Tuberculosis.

What drugs are being tested in NCT06224608?

Interventions: Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC).

What is the status of NCT06224608?

NCT06224608 is currently COMPLETED.

Last reviewed 2024-01-25 · How we verify

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

NCT06224608 PHASE1 COMPLETED

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).

Details

Lead sponsor	Chengdu CoenBiotech Co., Ltd
Phase	PHASE1
Status	COMPLETED
Enrolment	60
Start date	Tue Jan 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Tuberculosis

Interventions

Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)

Countries

China