A Multiple Ascending Dose Study of KBP-7072 in Healthy Subjects
- Registration Number
- NCT02654626
- Lead Sponsor
- KBP Biosciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KBP-7072: Cohort 3 Placebo Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 2 Placebo Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 4 KBP-7072 Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 1 Placebo Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 4 Placebo Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 1 KBP-7072 Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 2 KBP-7072 Healthy Volunteers will receive multiple dose of KBP-7072 and placebo KBP-7072: Cohort 3 KBP-7072 Healthy Volunteers will receive multiple dose of KBP-7072 and placebo
- Primary Outcome Measures
Name Time Method 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
Name Time Method Area Under Curve (AUC) in healthy subjects up to 10 days 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.
Trial Locations
- Locations (1)
Frontage Laboratories, Inc.
🇺🇸Secaucus, New Jersey, United States