NCT03376529

Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741

Completed Phase 1 Last updated 5 January 2018

What this trial tests

Phase 1 trial testing SPR741 in Healthy Volunteers in 27 participants. Completed in 20 December 2017.

Timeline

10 November 2017

Primary endpoint
19 December 2017

20 December 2017

Quick facts

Lead sponsor	Spero Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	10 November 2017
Primary completion	19 December 2017
Estimated completion	20 December 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• SPR741 — full drug profile →
• Ceftazidime (Ceftazidime) — full drug profile →
• Piperacillin/tazobactam
• Aztreonam (AZTREONAM) — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Spero Therapeutics — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, single-center, multi-arm, open-label, randomized, three-period, crossover study to evaluate the drug-drug interaction, pharmacokinetics, safety, and tolerability of a single dose of SPR741 combined with each of 3 different partner antibiotics (ceftazidime or piperacillin/tazobactam or aztreonam) in healthy volunteers. Participants will be administered single doses of SPR741 alone, a single dose of SPR741 in combination with 1 of 3 different partner antibiotics, and the partner antibiotic alone in a randomized sequence. Twenty-seven (27) adult male and female normal healthy participants 18 to 55 years of age are planned to participate in the study. Women of childbearing potential will not be eligible to participate.

Publications & conference data

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

1. Antibiotic resistance breakers: current approaches and future directions.
   Laws M, Shaaban A, Rahman KM. · · 2019 · cited 193× · PMID 31150547 · DOI 10.1093/femsre/fuz014
2. Antibiotics in the clinical pipeline in October 2019.
   Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
3. 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
4. Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with β-Lactam Antibiotics in Healthy Subjects.
   Eckburg PB, Lister T, Walpole S, Keutzer T, et al · · 2019 · cited 42× · PMID 31262767 · DOI 10.1128/aac.00892-19
5. Anti-<i>Pseudomonas aeruginosa</i> Vaccines and Therapies: An Assessment of Clinical Trials.
   Elmassry MM, Colmer-Hamood JA, Kopel J, San Francisco MJ, et al · · 2023 · cited 27× · PMID 37110338 · DOI 10.3390/microorganisms11040916
6. Advances and perspectives for antimicrobial peptide and combinatory therapies.
   C S, G R R, L F L, M C G DR, et al · · 2022 · cited 15× · PMID 36578509 · DOI 10.3389/fbioe.2022.1051456
7. Minireview on Novel Anti-infectious Treatment Options and Optimized Drug Regimens for Sepsis.
   Hites M. · · 2021 · cited 7× · PMID 33937283 · DOI 10.3389/fmed.2021.640740