CompletedPhase 1

Study to Assess the Intrapulmonary Pharmacokinetics of SPR206 in Healthy Volunteers

United Kingdom34 participantsStarted 2021-06-03

Plain-language summary

To evaluate the intrapulmonary pharmacokinetics (PK), including epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations, of SPR206 as well as plasma concentrations of SPR206 in healthy adult volunteers.

Who can participate

Age range18 Years – 55 Years

SexALL

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Exclusion criteria

✕. Fever, chills or sweats (temperature of 38 °C / 100.4 °F or higher)
✕. Difficulty breathing
✕. Cough
✕. Sore throat
✕. New or recent loss of taste or smell
✕. Nausea, vomiting or diarrhea
✕. White blood cell count \< 3,000/mm3, hemoglobin \< 11g/dL
✕. Absolute neutrophil count ≤ 2,000/mm3, platelet count \<120,000/mm3

What they're measuring

Area under the concentration-time curve from time 0 to 8 hours (AUC0-8) for ELF, AM, and plasma

Timeframe: 8 hours after the start of the third study drug IV infusion

Maximum observed concentration (Cmax) for ELF, AM, and plasma

Timeframe: 8 hours after the start of the third study drug IV infusion

Minimum concentration (Cmin) for ELF, AM, and plasma

Timeframe: 8 hours after the start of the third study drug IV infusion

Time to the maximum observed concentration (Tmax) for ELF, AM, and plasma

Timeframe: 8 hours after the start of the third study drug IV infusion

Trial details

NCT IDNCT04868292

SponsorSpero Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-16

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