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

A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03726853

Enrollment

220

Registered

2018-11-01

Start date

2018-05-29

Completion date

2019-03-21

Last updated

2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection

Keywords

Acute upper respiratory infection, Acute bronchitis

Brief summary

To evaluate the efficacy and safety of CKD-497

Interventions

DRUGCKD-497 200mg

CKD-497 200mg

DRUGCKD-497 300mg

CKD-497 300mg

DRUGCKD-497 placebo

Placebo of CKD-497

DRUGComparator

Comparator

DRUGComparator placebo

Comparator placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
BSS(Bronchitis Severity Score)	1 week	0(absent) \ 4(very severe), Total Score: 0\ 20
SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)	1 week	0(Never) \ 4(always), Total Score: 0\ 32

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026