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SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mg for Healthy Subjects

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 from the first dose of study drug through follow-up day 13

Awards & highlights

Study Summary

This trial studies how drugs move through the body and interact when taken together in healthy adults.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of study drug through follow-up day 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first dose of study drug through follow-up day 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug through follow-up day 13 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 Dosing Interval (AUC0-τ) for Study Drug

Maximum Observed Plasma Concentration (Cmax) of Study Drug

Time to Attain Maximum Plasma Concentration (tmax) for Study Drug

Secondary outcome measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Trial Design

5Treatment groups

Experimental Treatment

Group I: SPR720 1000 mg + Azithromycin 500 mg + Ethambutol 800 mgExperimental Treatment3 Interventions

Healthy participants will be co-administered SPR720 1000 mg, azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.

Group II: SPR720 1000 mgExperimental Treatment1 Intervention

Healthy participants will receive SPR720 1000 milligrams (mg), orally, once daily (QD) for 7 days.

Group III: Ethambutol 800 mgExperimental Treatment1 Intervention

Healthy participants will receive ethambutol 800 mg, orally, QD for 7 days.

Group IV: Azithromycin 500 mg + Ethambutol 800 mgExperimental Treatment2 Interventions

Healthy participants will be co-administered azithromycin 500 mg, and ethambutol 800 mg, orally, QD for 7 days.

Group V: Azithromycin 500 mgExperimental Treatment1 Intervention

Healthy participants will receive azithromycin 500 mg, orally, QD for 7 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azithromycin

2018

Completed Phase 4

~274950

Ethambutol

2023

Completed Phase 4

~3090

SPR720

2023

Completed Phase 1

~80

Do I qualify?Apply below to find out

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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

4,797 Total Patients Enrolled

Frequently Asked Questions

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

Are elderly individuals being considered as participants in this experiment?

"This research has set the age limit for participation as 18 or above, and no greater than 55."

Answered by AI

What have been the findings on the efficacy and safety of taking Ethambutol 800 mg?

"Due to the sparse evidence of safety and efficacy, our team at Power rated Ethambutol 800 mg a 1 on a scale from 1 to 3."

Answered by AI

Are there any vacancies for participation in this clinical trial?

"Correct. According to clinicaltrials.gov, this study is currently in search of participants and was initially listed on August 1st 2023 before being amended four days later. A total of 30 patients are required across one testing site."

Answered by AI

How many individuals have been invited to participate in this clinical research?

"Affirmative. According to clinicaltrials.gov, this trial is open and actively seeking participants after being first posted on August 1st 2023. Updates were made as recently as August 4th of the same year. 30 individuals are required across a single research site for completion of the experiment."

Answered by AI

What criteria must be met in order to qualify for participation in this clinical investigation?

"This trial is searching for 30 volunteers aged 18-55 who are in good health. Specific requirements include a BMI of between 18.0 and 32.0 kg/m2, weight within the range of 50 - 100kg, ability to provide suitable venous access for repeated blood sampling, and abstaining from alcohol, caffeine or xanthine containing food/beverages 48 hours prior to study drug administration until discharged from the CRU."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants

2023. "A Study to Evaluate the Effect of Co-administration on the Pharmacokinetics of SPR720, Azithromycin, and Ethambutol in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05966688.