Study of KBP-7072 in Healthy Male and Female Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2023-06-29

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

KBP-7072

Intervention Type DRUG

KBP-7072

Placebo

Placebo for intravenous infusion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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KBP-7072

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes