NCT02654626

A Randomized, Single-blind, Placebo-controlled, Sequential Parallel-Group and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-7072 in Healthy Subjects

Completed Phase 1 Last updated 21 February 2024

What this trial tests

Phase 1 trial testing KBP-7072 in Healthy in 16 participants. Completed in 1 December 2015.

Timeline

1 October 2015

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	KBP Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	16
Start date	1 October 2015
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	1 location across United States

Drugs / interventions tested

• KBP-7072 — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

KBP Biosciences — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects
  Time frame: up to 17 days

Sponsor's own description

This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.

Publications & conference data

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

1. 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
2. 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
3. Emerging Treatment Options for Infections by Multidrug-Resistant Gram-Positive Microorganisms.
   Koulenti D, Xu E, Song A, Sum Mok IY, et al · · 2020 · cited 27× · PMID 32019171 · DOI 10.3390/microorganisms8020191
4. <i>In Vitro</i> Activity of KBP-7072, a Novel Third-Generation Tetracycline, against 531 Recent Geographically Diverse and Molecularly Characterized Acinetobacter baumannii Species Complex Isolates.
   Huband MD, Mendes RE, Pfaller MA, Lindley JM, et al · · 2020 · cited 22× · PMID 32071042 · DOI 10.1128/aac.02375-19
5. Novel drug candidates against antibiotic-resistant microorganisms: A review.
   Lim JS, Chai YY, Ser WX, Haeren AV, et al · · 2024 · cited 14× · PMID 38234674 · DOI 10.22038/ijbms.2023.71672.15593
6. 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
7. <i>In Vitro</i> Activity of KBP-7072 against 536 Acinetobacter baumannii Complex Isolates Collected in China.
   Han R, Ding L, Yang Y, Guo Y, et al · · 2022 · cited 10× · PMID 35138143 · DOI 10.1128/spectrum.01471-21