Study of KBP-7072 in Healthy Male and Female Subjects

KBP Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: KBP-7072

Study type: Interventional

Funder types: Industry

Identifiers

NCT05507463

KBP7072-1-004

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

KBP-7072

Experimental group

Description:

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.

Treatment:

Drug: KBP-7072

Placebo

Placebo Comparator group

Description:

Placebo for intravenous infusion.

Treatment:

Drug: Placebo