The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497

Chong Kun Dang

Status and phase: Completed; Phase 2

Conditions: Respiratory Infection

Treatments: Drug: CKD-497 300mg; Drug: Comparator placebo; Drug: CKD-497 placebo; Drug: CKD-497 200mg; Drug: Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03726853

176AURI/AB17014

Details and patient eligibility

About

To evaluate the efficacy and safety of CKD-497

Enrollment: 220 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 19 ≤ age < 75
2. Subject with acute upper respiratory infection and acute bronchitis infection
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion criteria

1. Subject who need antibiotics treatment during the clinical trial
2. Subject suffering from severe respiratory diseases such as pneumonia, asthma, chronic closed lung diseases (COPD), tuberculosis, bronchial enlargement, malignant tumors in the lungs, and chronic bronchitis during screening
3. Subject who cannot participate in a clinical trial based on the PI's judgment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups, including a placebo group

CKD-497 200mg

Experimental group

Description:

CKD-497 200mg

Treatment:

Drug: CKD-497 200mg

Drug: Comparator placebo

CKD-497 300mg

Experimental group

Description:

CKD-497 300mg

Treatment:

Drug: CKD-497 300mg

Drug: Comparator placebo

Active Comparator

Active Comparator group

Description:

compartor

Treatment:

Drug: CKD-497 placebo

Drug: Comparator

Placebo

Placebo Comparator group

Description:

CKD-497 placebo and comparator placebo

Treatment:

Drug: CKD-497 placebo

Drug: Comparator placebo