Study of KBP-7072 in Healthy Male and Female Subjects

A Phase I, Double-blind, Placebo-controlled, Single and Multiple Intravenous Dose, Safety, Tolerability and Pharmacokinetic Study of KBP-7072 in Healthy Male and Female Subjects

This is a double-blind, randomized, placebo-controlled, single and multiple IV dose study conducted in two parts. Part A (SAD) will comprise an ascending single dose, sequential group design. Each subject will participate in 1 treatment period only. Subjects will reside at the study site from check-in on Day -1 (the day before dosing) to discharge on Day 8. In Part A, serial blood and urine collections will be obtained on Day 1 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings. Part B (MAD) will comprise an ascending multiple dose, sequential group study. Each subject will participate on one treatment period only and reside at the study site from check-in on Day -1 until discharge on Day 17. In Part B, serial blood and urine collections will be obtained on Day 1 pre-dose through 24 hours post start of infusion and on Day 10 pre-dose through 168 hours post start of infusion for analysis of plasma and urine concentrations of KBP-7072 and KBP-6079. Trough blood sample collections for analysis of plasma concentrations of KBP-7072 and KBP-6079 will be obtained pre-dose on Days 3, 4, 5, 6, 7, 8 and 9. Safety will be monitored through recording of adverse events, clinical laboratory evaluations, vital sign measurements, 12-lead ECG and physical examination findings.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel International - Early Phase Clinical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI between 18 and 30 kg/m2 at the time of screening
• In good health, determined b no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements and clinical laboratory evaluations
• Females of nonchildbearing potential defined as permanently sterile or postmenopausal.

Males will agree to use contraception.

Exclusion Criteria:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine or psychiatric disorder as determined by the investigator.
• Abnormal results of ophthalmologic examination within 3 months prior to dosing self-reported by subject.
• Supine systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
• Triglycerides > 200 mg/dL
• Total cholesterol > 240 mg/dL or LDL >190 mg/dL or HDL < 40 mg/dL
• Positive urine drug screen at screening or check-in or positive blood alcohol test result at check-in.
• Positive hepatitis panel and/or positive HIV test
• Administration of a Covid-19 vaccine in the past 28 days prior to dosing
• Interpretation of liver ultrasound with presence of fatty liver disease

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KBP-7072; Proposed dose levels for Part A: 25, 50, 100, 150 and 200mg KBP-7072. Proposed dose levels for Part B: 50 and 100mg. Administration route is intravenous infusion.	Drug: KBP-7072; KBP-7072
Placebo Comparator: Placebo; Placebo for intravenous infusion.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations	Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.	Time Frame: SAD 1- 7 days and MAD 1-17 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Parameters :AUC from time 0 extrapolated to infinity (AUC0-∞)	AUC from time 0 extrapolated to infinity (AUC0-∞)	SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast),	Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma	SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: AUC over a dosing interval (AUC0-τ), from time zero to time of last quantifiable concentration (AUC0-tlast)from time zero to time of last quantifiable concentration (AUC0-tlast)	AUC over a dosing interval (AUC0-τ) - Plasma	MAD samples will be collected on Day 1 pre-dose and at 5, 15, 30, 45 minutes, and at 1, 1.5, 2, 4, 6, 10, 12, 24 (Day 2) hours, pre-dose samples at 48 (Day 3), 72 (Day 4), 96 (Da
Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax)	Maximum observed plasma concentration (Cmax) - Plasma	SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax)	Time of the maximum observed plasma concentration (Tmax) - Plasma	SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168 (Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2)	Apparent terminal elimination half-life (t1/2) - Plasma	SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168(Day 8) hour(s) post start of infusion
Pharmacokinetics Parameters: observed accumulation ratio based on AUC0-τ (ARAUC0-τ)	Observed accumulation ratio based on AUC0-τ (ARAUC0-τ) - Plasma	MAD samples will be collected on Day 1 pre-dose and at 5, 15, 30, 45 minutes, and at 1, 1.5, 2, 4, 6, 10, 12, 24 (Day 2) hours, pre-dose samples at 48 (Day 3), 72 (Day 4), 96 (Da
Pharmacokinetics Parameters: amount of drug excreted in urine (Ae)	Amount of drug excreted in urine (Ae) - Urine	SAD Day 1 predose (within the 30 minutes prior to dosing) and at 5, 15,30,45 minutes and at 1,1.5,2,4,6,10,12,24 (day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7) and 168(Day 8) hour(s) post start of infusion

Collaborators and Investigators

• Sponsor: KBP Biosciences
• Collaborators: Parexel
• Investigators: Principal Investigator: Ronald Goldwater, Parexel

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (Actual): August 19, 2022

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

• Other Study ID Numbers: KBP7072-1-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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