NCT05507463

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: KBP Biosciences · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	KBP-7072	KBP-7072
DRUG	Placebo	Placebo

Timeline

• Start date: 2022-08-16
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2022-08-19
• Last updated: 2024-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study