A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB1578 When Administered Orally to Healthy Adult Subjects With One Single-Dose Group Crossing Over to Assess Food Effect

S*BIO1 site in 1 country40 target enrollmentAugust 2010

InterventionsSB1578 Placebo

Overview

Phase: Phase 1
Intervention: SB1578
Conditions: Healthy Volunteer
Sponsor: S*BIO
Enrollment: 40
Locations: 1
Primary Endpoint: Assess number of participants with adverse events as a measure of safety and tolerability
Status: Completed
Last Updated: 14 years ago

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of SB1578 in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

S*BIO

Responsible Party

Sponsor

•Healthy adult males and/or females of non-childbearing potential, 18 to 55 years of age (inclusive).
•Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55 and 100 kg (inclusive).
•Medically healthy with clinically insignificant screening results.

Intervention: SB1578

Intervention: Placebo

Assess number of participants with adverse events as a measure of safety and tolerability

Time Frame: 312 hours postdose

Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve(Predose to 312 hours postdose)
Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5(Predose, 6 and 24 hours postdose)
Assess food effects on pharmacokinetics(Predose to 312 hours postdose)
Determine recommended dose(March 2011)