NCT04654143 is a Phase 1 clinical trial of BVL-GSK098 capsule, placebo in Healthy Volunteers, sponsored by BioVersys AG.

Who is sponsoring NCT04654143?

NCT04654143 is sponsored by BioVersys AG.

What drugs are being tested in NCT04654143?

Interventions in NCT04654143: BVL-GSK098 capsule, placebo.

What condition does NCT04654143 study?

NCT04654143 studies Healthy Volunteers.

Is NCT04654143 still recruiting?

NCT04654143 is currently completed. Last updated 18 January 2023.

Last reviewed 2023-01-18 · How we verify

NCT04654143

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

Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BVL-GSK098 in Healthy Volunteers

Completed Phase 1 Last updated 18 January 2023

What this trial tests

Phase 1 trial testing BVL-GSK098 capsule, placebo in Healthy Volunteers in 80 participants. Completed in 16 January 2023.

Timeline

2 December 2020

Primary endpoint
30 May 2022

16 January 2023

Quick facts

Lead sponsor	BioVersys AG
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	2 December 2020
Primary completion	30 May 2022
Estimated completion	16 January 2023
Sites	2 locations across Spain

Drugs / interventions tested

BVL-GSK098 capsule, placebo — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

BioVersys AG — 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 I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers

Publications & conference data

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

Analysis of the Clinical Pipeline of Treatments for Drug-Resistant Bacterial Infections: Despite Progress, More Action Is Needed.
Butler MS, Gigante V, Sati H, Paulin S, et al · · 2022 · cited 165× · PMID 35007139 · DOI 10.1128/aac.01991-21
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
Revolutionizing tuberculosis treatment: Breakthroughs, challenges, and hope on the horizon.
Kufa M, Finger V, Kovar O, Soukup O, et al · · 2025 · cited 6× · PMID 40370552 · DOI 10.1016/j.apsb.2025.01.023
How a PCR Sequencing Strategy Can Bring New Data to Improve the Diagnosis of Ethionamide Resistance.
Maitre T, Morel F, Brossier F, Sougakoff W, et al · · 2022 · cited 3× · PMID 35889155 · DOI 10.3390/microorganisms10071436
First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug.
Pieren M, Abáigar Gutiérrez-Solana A, Antonijoan Arbós RM, Boyle GW, et al · · 2024 · cited 2× · PMID 38656557 · DOI 10.1093/jac/dkae107

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
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 BioVersys AG trials

Trials by the same sponsor.

NCT07350174 — Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis · Phase 2 · not yet recruiting
NCT05684705 — Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 · Phase 1 · completed
NCT05685615 — PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB · Phase 2 · completed
NCT05684718 — To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100 · Phase 1 · completed
NCT05537142 — A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment · 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 NCT04654143 (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 BioVersys AG
Last refreshed: 18 January 2023

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/NCT04654143.

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