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Completed

NCT Number: NCT05507463

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International - Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KBP-7072

Drug

KBP-7072

Placebo

Drug

Placebo

Primary outcomes

  1. Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

    Time frame: Time Frame: SAD 1- 7 days and MAD 1-17 days

    Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.

Secondary outcomes

  1. Pharmacokinetics Parameters :AUC from time 0 extrapolated to infinity (AUC0-∞)

    Time frame: 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

    AUC from time 0 extrapolated to infinity (AUC0-∞)

  2. Pharmacokinetics Parameters: Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast),

    Time frame: 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

    Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma

  3. 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)

    Time frame: 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

    AUC over a dosing interval (AUC0-τ) - Plasma

  4. Pharmacokinetics Parameters: Maximum observed plasma concentration (Cmax)

    Time frame: 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

    Maximum observed plasma concentration (Cmax) - Plasma

  5. Pharmacokinetics Parameters: time of the maximum observed plasma concentration (Tmax)

    Time frame: 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

    Time of the maximum observed plasma concentration (Tmax) - Plasma

  6. Pharmacokinetics Parameters: apparent terminal elimination half-life (t1/2)

    Time frame: 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

    Apparent terminal elimination half-life (t1/2) - Plasma

  7. Pharmacokinetics Parameters: observed accumulation ratio based on AUC0-τ (ARAUC0-τ)

    Time frame: 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

    Observed accumulation ratio based on AUC0-τ (ARAUC0-τ) - Plasma

  8. Pharmacokinetics Parameters: amount of drug excreted in urine (Ae)

    Time frame: 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

    Amount of drug excreted in urine (Ae) - Urine

Sponsors and collaborators

Lead sponsor

KBP Biosciences

Industry

Collaborators

  • Parexel

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2022
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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