Safety, Tolerability and Pharmacokinetics of KBP-7072

KBP Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: KBP-7072

Study type: Interventional

Funder types: Industry

Identifiers

NCT02454361

KBP7072-1-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 6 patient groups

KBP-7072 cohort 1

Experimental group

Description:

KBP-7072 by mouth once

Treatment:

Drug: KBP-7072

Drug: Placebo

KBP-7072 cohort 2

Experimental group

Description:

KBP-7072 by mouth once

Treatment:

Drug: KBP-7072

Drug: Placebo

KBP-7072 cohort 3

Experimental group

Description:

KBP-7072 by mouth once

Treatment:

Drug: KBP-7072

Drug: Placebo

KBP-7072 cohort 4

Experimental group

Description:

KBP-7072 by mouth once

Treatment:

Drug: KBP-7072

Drug: Placebo

KBP-7072 cohort 5

Experimental group

Description:

KBP-7072 by mouth once

Treatment:

Drug: KBP-7072

Drug: Placebo

KBP-7072 Fed Group

Experimental group

Description:

KBP-7072 by mouth once to the fed group

Treatment:

Drug: KBP-7072