NCT04376554 is a Phase 1 clinical trial of TBPM-PI-HBr in Healthy Volunteers, sponsored by Spero Therapeutics.

Who is sponsoring NCT04376554?

NCT04376554 is sponsored by Spero Therapeutics.

What drugs are being tested in NCT04376554?

Interventions in NCT04376554: TBPM-PI-HBr, amoxicillin-clavulanate.

What condition does NCT04376554 study?

NCT04376554 studies Healthy Volunteers.

Is NCT04376554 still recruiting?

NCT04376554 is currently completed. Last updated 4 May 2021.

Last reviewed 2021-05-04 · How we verify

NCT04376554

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Tebipenem on Normal Human Intestinal Microbiota

Completed Phase 1 Last updated 4 May 2021

What this trial tests

Phase 1 trial testing TBPM-PI-HBr in Healthy Volunteers in 30 participants. Completed in 6 April 2021.

Timeline

10 February 2020

Primary endpoint
6 April 2021

6 April 2021

Quick facts

Lead sponsor	Spero Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	10 February 2020
Primary completion	6 April 2021
Estimated completion	6 April 2021
Sites	1 location across Sweden

Drugs / interventions tested

TBPM-PI-HBr — full drug profile →
amoxicillin-clavulanate — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Spero Therapeutics — full company profile →

Who can join

18 and older, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall purpose of this study is to support the development of an oral formulation of TBPM-PI-HBr by assessing the potential ecological effects of tebipenem on the normal intestinal microbiota as compared to the effects of oral amoxicillin-clavulanate.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of tebipenem pivoxil hydrobromide on the normal gut microbiota of a healthy adult population in Sweden: a randomised controlled trial.
Sewunet T, Razavi M, Rosenborg S, Camporeale A, et al · · 2024 · cited 5× · PMID 38432233 · DOI 10.1016/s2666-5247(23)00360-9

Verify or expand the search:

Other trials of TBPM-PI-HBr

Trials testing the same drug.

NCT04710407 — Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), an · Phase 1 · completed
NCT04625855 — Study of the Absorption, Metabolism, and Excretion of [14C]-Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) Following a Sin · Phase 1 · completed
NCT03788967 — Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) · Phase 3 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Spero Therapeutics trials

Trials by the same sponsor.

NCT06727136 — A Study to Characterize Single and Repeat Dose Pharmacokinetics of Tebipenem-Pivoxil-Hydrobromide (TBP-PI-HBr) and Its M · Phase 1 · completed
NCT06059846 — A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants · Phase 3 · completed
NCT05966688 — A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in H · Phase 1 · completed
NCT05955586 — A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, a · Phase 1 · completed
NCT05856747 — A Study to Compare Two Bioanalytical Assays for Tebipenem · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04376554 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spero Therapeutics
Last refreshed: 4 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04376554.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing