NCT05507463

Study of KBP-7072 in Healthy Male and Female Subjects

Completed Phase 1 Last updated 23 February 2024

What this trial tests

Phase 1 trial testing KBP-7072 in Healthy Subjects in 56 participants. Completed in 29 June 2023.

Timeline

16 August 2022

Primary endpoint
29 June 2023

29 June 2023

Quick facts

Lead sponsor	KBP Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	56
Start date	16 August 2022
Primary completion	29 June 2023
Estimated completion	29 June 2023
Sites	1 location across United States

Drugs / interventions tested

• KBP-7072 — full drug profile →
• Placebo

Conditions studied

• Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

KBP Biosciences — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. ESKAPE pathogens: antimicrobial resistance, epidemiology, clinical impact and therapeutics.
   Miller WR, Arias CA. · · 2024 · cited 481× · PMID 38831030 · DOI 10.1038/s41579-024-01054-w
2. Antibiotics in the clinical pipeline as of December 2022.
   Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8
3. Unveiling the Secrets of <i>Acinetobacter baumannii</i>: Resistance, Current Treatments, and Future Innovations.
   Marino A, Augello E, Stracquadanio S, Bellanca CM, et al · · 2024 · cited 44× · PMID 38999924 · DOI 10.3390/ijms25136814
4. Antibacterials with Novel Chemical Scaffolds in Clinical Development.
   Heimann D, Kohnhäuser D, Kohnhäuser AJ, Brönstrup M. · · 2025 · cited 10× · PMID 39847315 · DOI 10.1007/s40265-024-02137-x