Multiple Ascending Doses Study of CG400549

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and tolerability of 3 multiple and escalating dose regimens of CG400549 administered orally in healthy volunteers.

Detailed Description
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This is a Phase 1, 3 cohorts study consisting of a randomised, double-blind, and placebo-controlled design.

Official Title
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Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of Multiple Ascending Doses of CG400549 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: CG400549 640mg
* Drug: CG400549 320 mg
* Drug: CG400549 640 mg
* Drug: CG400549 960 mg
* Drug: Placebo 640mg
* Drug: Placebo 320mg
* Drug: placebo 960 mg
* Drug: Placebo 640mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-55 years, inclusive Body Mass Index :19-30 kg/m2, inclusive Sex:male Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day Exclusion Criteria: Evidence of clinically relevant pathology History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E1. CG400549 640mg<br>CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state | Drug: CG400549 640mg<br>* multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state<br>|
| Experimental: E2: CG400549 320mg<br>CG400549 320mg QD on Day 1-5 in the fed-state. | Drug: CG400549 320 mg<br>* multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state<br>|
| Experimental: E3: CG400549 640mg<br>CG400549 640mg QD on Day 1-5 in the fed-state. | Drug: CG400549 640 mg<br>* multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state<br>|
| Experimental: E4: CG400549 960mg<br>CG400549 960mg QD on Day 1-5 in the fed-state. | Drug: CG400549 960 mg<br>* multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state<br>|
| Placebo Comparator: P1 Placebo<br>Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state | Drug: Placebo 640mg<br>* multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state<br>|
| Placebo Comparator: P2: Placebo 320mg<br>Placebo 320mg QD on Day 1-5 in the fed-state | Drug: Placebo 320mg<br>* multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state<br>|
| Placebo Comparator: P3 Placebo 640mg<br>Placebo 640mg QD on Day 1-5 in the fed-state. | Drug: placebo 960 mg<br>* multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state<br>|
| Placebo Comparator: P4: Placebo 960mg<br>Placebo 960mg QD on Day 1-5 in the fed-state. | Drug: Placebo 640mg<br>* multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | From Time the ICF is signed until Follow up Visit (15 days after study drug administration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics-tmax(h), Cmax (ng/mL), Auc (0-24), T1/2(h) | To determine the pharmacokinetics of CG400549 following oral administration of multiple ascending doses of CG400549 in healthy male subjects. | Day1 and Day5 |