Clinical Trial

Testing Experimental Medication in Healthy Subjects

Study Description

A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults

Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - TBI-223 50mg

TBI-223 50 mg supplied for oral administration.

Drug - Placebo for TBI-223 50mg

Matching placebo for TBI-223 50mg supplied for oral administration.

Drug - TBI-223 100, 300, 600, 1200, 2000, 2600 mg

TBI-223 100, 300, 600, 1200, 2000, 2600 mg supplied for oral administration.

Drug - Placebo for TBI-223 100, 300, 600, 1200, 2000, 2600 mg

Matching placebo for 100, 300, 600, 1200, 2000, 2600 mg TBI-223 supplied for oral administration.

Drug - TBI-223 300 mg capsule

TBI-223 300 mg capsule supplied for oral administration

Drug - Placebo for TBI-223 300 mg capsule

Placebo for TBI-223 300 mg capsule supplied for oral administration

Drug - TBI-223 Prototype 1 SR Tablet

Prototype 1 TBI-223 600 mg sustained-release (SR) tablet

Drug - TBI-223 Prototype 2 SR Tablet

Prototype 2 TBI-223 600 mg SR tablet

Drug - TBI-223 Prototype 3 SR Tablet

Prototype 3 TBI-223 900 mg SR tablet

Drug - TBI-223 IR Tablet

TBI-223 1000 mg immediate release (IR) tablet

Additional Information

Official Study Title

A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) With a Food Effect Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adult Participants.

Clinical Trial ID

NCT03758612

ParticipAid ID

av2mVa