ORAvance (BRII-672)
/ Brii Biosci, Shionogi
- LARVOL DELTA
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November 04, 2025
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
(clinicaltrials.gov)
- P1 | N=71 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial primary completion date: Aug 2025 ➔ Dec 2025
Trial primary completion date • Infectious Disease
May 14, 2025
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
(clinicaltrials.gov)
- P1 | N=32 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed
Trial completion • Infectious Disease • Renal Disease
February 27, 2025
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
(clinicaltrials.gov)
- P1 | N=32 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Not yet recruiting ➔ Recruiting
Enrollment open • Infectious Disease • Renal Disease
February 27, 2025
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
(clinicaltrials.gov)
- P1 | N=71 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Sep 2024 ➔ Aug 2025
Trial completion date • Trial primary completion date • Infectious Disease
August 09, 2024
PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment
(clinicaltrials.gov)
- P1 | N=32 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc. | Initiation date: Jun 2024 ➔ Oct 2024
Trial initiation date • Infectious Disease • Renal Disease
April 04, 2024
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
(clinicaltrials.gov)
- P1 | N=72 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Not yet recruiting ➔ Recruiting
Enrollment open • Infectious Disease
December 05, 2023
P1, Open-label, SAD PK & Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Renal Impairment Pts
(clinicaltrials.gov)
- P1 | N=32 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc.
New P1 trial • Infectious Disease • Renal Disease
November 06, 2023
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
(clinicaltrials.gov)
- P1 | N=72 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc. | N=48 ➔ 72
Combination therapy • Enrollment change • Infectious Disease
October 12, 2023
P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants
(clinicaltrials.gov)
- P1 | N=48 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc.
Combination therapy • New P1 trial • Infectious Disease
September 23, 2022
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
(clinicaltrials.gov)
- P1 | N=75 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed
Trial completion • Infectious Disease
February 14, 2022
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
(clinicaltrials.gov)
- P1 | N=78 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial completion date: Apr 2022 ➔ Aug 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022
Trial completion date • Trial primary completion date • Infectious Disease
November 25, 2021
Selection of QPX7831, an Orally Bioavailable Prodrug of Boronic Acid β-Lactamase Inhibitor QPX7728.
(PubMed, J Med Chem)
- "Seventeen prodrugs were synthesized; key properties investigated were rates of cleavage to the active form in vitro, pharmacokinetics across species, and crystallinity. Compound 5-Na (QPX7831 Sodium) emerged with optimal properties across all key attributes."
Journal • Infectious Disease
March 05, 2021
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
(clinicaltrials.gov)
- P1; N=80; Recruiting; Sponsor: Qpex Biopharma, Inc.; Not yet recruiting ➔ Recruiting
Clinical • Enrollment open • Infectious Disease
October 30, 2020
Phase 1 Oral QPX7831 SAD and MAD in Healthy Adults
(clinicaltrials.gov)
- P1; N=80; Not yet recruiting; Sponsor: Qpex Biopharma, Inc.; N=136 ➔ 80
Clinical • Enrollment change • Infectious Disease
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