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SPR720 Pharmacokinetics in Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Spero Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on day 6 and post-dose at multiple time points up to day 8
Awards & highlights

Study Summary

This trial will study the effects of a drug taken orally over 7 days on pulmonary fluid and cells.

Who is the study for?
Healthy volunteers with good lung function (FEV1 ≥80% of predicted), suitable veins for blood sampling, a BMI between 18.0 and 32.0 kg/m^2, and weight from 55 to 100 kg can join this trial. They must avoid alcohol, caffeine, and certain foods before taking the study drug.Check my eligibility
What is being tested?
The trial is testing SPR720 capsules taken orally once daily for a week by healthy people to see how much of the drug gets into different parts of the lungs compared to their blood levels.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include reactions related to oral medication such as gastrointestinal discomfort or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on day 6 and post-dose at multiple time points up to day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on day 6 and post-dose at multiple time points up to day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve from Time Zero to 24 Hours (AUC0-24) of SPR719 in plasma, ELF and AM
Maximum Observed Concentration (Cmax) of SPR719 in plasma, ELF and AM
Time to the Maximum Observed Concentration (Tmax) of SPR719 in plasma, ELF and AM
Secondary outcome measures
Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: SPR720Experimental Treatment1 Intervention
Healthy participants will receive SPR720 1000 mg capsule, orally, for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPR720
2023
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Spero TherapeuticsLead Sponsor
22 Previous Clinical Trials
4,803 Total Patients Enrolled

Media Library

SPR720 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05955586 — Phase 1
Healthy Subjects Research Study Groups: SPR720
Healthy Subjects Clinical Trial 2023: SPR720 Highlights & Side Effects. Trial Name: NCT05955586 — Phase 1
SPR720 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05955586 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research involve participants of thirty years or older?

"The eligibility requirements for this trial specify that the age of participants must be between 18 and 55 years old."

Answered by AI

To what degree does SPR720 pose a risk to those using it medicinally?

"This new drug has only been tested in a Phase 1 clinical trial, so its safety rating is comparatively low at 1. Despite the lack of evidence for SPR720's efficacy and safety, it may still provide promising results."

Answered by AI

Are there still opportunities for individuals to partake in this research?

"This clinical trial, which was first announced on the 1st of August in 2023 and recently updated on the 14th of August, is currently recruiting participants."

Answered by AI

What is the maximum capacity of this research experiment?

"Indeed. Clinicaltrials.gov reveals that this clinical trial is currently seeking applicants and was initially published on August 1st, 2023 with a recent update occurring on the 14th of August. Thirty participants need to be enrolled at one site for the study's completion."

Answered by AI

Who qualifies for participation in this experiment?

"This medical trial requires 30 participants of sound health, aged 18-55. Exclusion criteria include: BMI ranging from 18 to 32 kg/m^2; weight between 55 and 100kg; FEV1 at least 80% of the predicted value upon screening visit; suitable venous access for blood sampling; abstaining from alcohol, caffeine, xanthine-containing beverages or food 48 hours prior to drug administration until discharged from the CRU."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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.
2023. "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.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05955586.
~20 spots leftby Apr 2025
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