A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects

Study Overview
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Brief Summary
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This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.

Official Title
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A Randomized, Single-blind, Placebo-controlled, Sequential Parallel-Group and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: KBP-7072
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subject Are between the ages of 18 and 55 years (inclusive); Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg. Exclusion Criteria: Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity; Known or suspected malignancy; Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibody; Positive pregnancy test result.

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

Sexes Eligible for Study
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All

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KBP-7072: Cohort 1<br>Healthy Volunteers will receive multiple dose of KBP-7072 and placebo | Drug: KBP-7072<br>* Drug Intervention<br>Other: Placebo<br> <br> |
| Experimental: KBP-7072: Cohort 2<br>Healthy Volunteers will receive multiple dose of KBP-7072 and placebo | Drug: KBP-7072<br>* Drug Intervention<br>Other: Placebo<br> <br> |
| Experimental: KBP-7072: Cohort 3<br>Healthy Volunteers will receive multiple dose of KBP-7072 and placebo | Drug: KBP-7072<br>* Drug Intervention<br>Other: Placebo<br> <br> |
| Experimental: KBP-7072: Cohort 4<br>Healthy Volunteers will receive multiple dose of KBP-7072 and placebo | Drug: KBP-7072<br>* Drug Intervention<br>Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects |  | up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) in healthy subjects | on Day 1 (first dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours post dose; on Days 4, 7, 8, and 9: pre-dose (within 30 minutes prior to dosing); on Day 10 (last dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose. | up to 10 days |