A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

December 18, 2018

Primary Completion Date

September 24, 2019

Study Completion Date

September 24, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

SPR720 for SAD

Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered as a single dose.

DRUG

Placebo for SAD

Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally as a single dose.

DRUG

SPR720 for MAD

Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing.

DRUG

Placebo for MAD

Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing

Trial Locations (1)

CF48 4DR

Simbec Research, Ltd., Merthyr Tydfil

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Simbec Research

INDUSTRY

lead

Spero Therapeutics

INDUSTRY

NCT03796910 - A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers | Biotech Hunter | Biotech Hunter