A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 Following Oral Administration
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- KBP Biosciences
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- The safety and tolerability (i.e., number of participants with adverse events): predose and postdose
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel.
Detailed Description
This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single ascending dose administration and with an open label food effect panel. Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight subjects in each dose cohort, six subjects randomized to active drug and two subjects randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose). Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed conditions. The dose tested in Part 2 will be determined based on the safety, tolerability and PK data available from Part 1. Extensive PK samplings will be collected after dosing (pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose). Safety assessments will include monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.
Investigators
Eligibility Criteria
Inclusion Criteria
- •males and surgically sterile or postmenopausal females
- •aged between 18-45 years
- •body mass index (BMI) 19 ≤ BMI ≤ 30 kg/m2,
- •no significant medical history
- •normal renal function
- •good general health
Exclusion Criteria
- •Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, pulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
Arms & Interventions
KBP-7072 cohort 3
KBP-7072 by mouth once
Intervention: Placebo
KBP-7072 cohort 4
KBP-7072 by mouth once
Intervention: KBP-7072
KBP-7072 cohort 1
KBP-7072 by mouth once
Intervention: KBP-7072
KBP-7072 cohort 1
KBP-7072 by mouth once
Intervention: Placebo
KBP-7072 cohort 2
KBP-7072 by mouth once
Intervention: KBP-7072
KBP-7072 cohort 2
KBP-7072 by mouth once
Intervention: Placebo
KBP-7072 cohort 3
KBP-7072 by mouth once
Intervention: KBP-7072
KBP-7072 cohort 4
KBP-7072 by mouth once
Intervention: Placebo
KBP-7072 cohort 5
KBP-7072 by mouth once
Intervention: KBP-7072
KBP-7072 cohort 5
KBP-7072 by mouth once
Intervention: Placebo
KBP-7072 Fed Group
KBP-7072 by mouth once to the fed group
Intervention: KBP-7072
Outcomes
Primary Outcomes
The safety and tolerability (i.e., number of participants with adverse events): predose and postdose
Time Frame: 10 days
Secondary Outcomes
- Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose(10 days)
- Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose among participants who have had food(10 days)