Safety, Tolerability and Pharmacokinetics of KBP-7072

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: KBP-7072

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • KBP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KBP-7072 cohort 1; KBP-7072 by mouth once	Drug: Placebo; Placebo; Drug: KBP-7072; KBP-7072
Experimental: KBP-7072 cohort 2; KBP-7072 by mouth once	Drug: Placebo; Placebo; Drug: KBP-7072; KBP-7072
Experimental: KBP-7072 cohort 3; KBP-7072 by mouth once	Drug: Placebo; Placebo; Drug: KBP-7072; KBP-7072
Experimental: KBP-7072 cohort 4; KBP-7072 by mouth once	Drug: Placebo; Placebo; Drug: KBP-7072; KBP-7072
Experimental: KBP-7072 cohort 5; KBP-7072 by mouth once	Drug: Placebo; Placebo; Drug: KBP-7072; KBP-7072
Experimental: KBP-7072 Fed Group; KBP-7072 by mouth once to the fed group	Drug: KBP-7072; KBP-7072

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The safety and tolerability (i.e., number of participants with adverse events): predose and postdose	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: KBP Biosciences

Publications and helpful links

General Publications

• Huband MD, Mendes RE, Pfaller MA, Lindley JM, Strand GJ, Benn VJ, Zhang J, Li L, Zhang M, Tan X, Liu Q, Flamm RK. In Vitro Activity of KBP-7072, a Novel Third-Generation Tetracycline, against 531 Recent Geographically Diverse and Molecularly Characterized Acinetobacter baumannii Species Complex Isolates. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02375-19. doi: 10.1128/AAC.02375-19. Print 2020 Apr 21.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimated): May 27, 2015

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Safety; tolerability; pharmacokinetics; KBP-7072
• Other Study ID Numbers: KBP7072-1-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No