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NCT05955586
A Study to Assess the Intrapulmonary Pharmacokinetics (PK) of SPR719 by Comparing the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations Following the Oral Administration of Multiple Doses of SPR720 in Healthy Volunteers.
Phase 1 trial testing SPR720 in Healthy Volunteer in 33 participants. Completed in 23 February 2024.
9 February 2024
Quick facts
| Lead sponsor | Spero Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 August 2023 |
| Primary completion | 9 February 2024 |
| Estimated completion | 23 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SPR720 — full drug profile →
Conditions studied
- Healthy Volunteer — all drugs for Healthy Volunteer →
Sponsor
Spero Therapeutics — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this study is to evaluate the intrapulmonary PK, including epithelial lining fluid (ELF) and alveolar macrophages (AM) concentrations, of SPR719 compared to plasma concentrations of SPR719 (the active moiety in plasma of the prodrug SPR720) after oral administration of SPR720 1000 milligram (mg) capsules every 24 hours for 7 consecutive doses.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
<i>M. avium Complex</i> Pulmonary Infections: Therapeutic Obstacles and Progress in Drug Development.
Charrier ESA, Dassonville-Klimpt A, Andréjak C, Sonnet P. · · 2025 · cited 2× · PMID 40573286 · DOI 10.3390/ph18060891 -
Intrapulmonary pharmacokinetics of SPR719 following oral administration of SPR720 to healthy volunteers.
Rodvold KA, Gotfried MH, Ussery XT, Wong SL, et al · · 2024 · cited 2× · PMID 39352135 · DOI 10.1128/aac.01103-24
Verify or expand the search:
- PubMed search for NCT05955586
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of SPR720
Trials testing the same drug.
- NCT05966688 — A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in H · Phase 1 · completed
- NCT04553406 — Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Com · Phase 2 · terminated
Other recruiting trials for Healthy Volunteer
Currently open trials in the same condition.
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- NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
- NCT07220122 — Impact of Exogenous Ketones on Breathing in Healthy Volunteers · EARLY_PHASE1 · 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
- NCT05856747 — A Study to Compare Two Bioanalytical Assays for Tebipenem · Phase 1 · completed
- NCT05496374 — A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05955586 (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: 7 March 2024
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/NCT05955586.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing