A Single and Multiple-Dose Study of SB1578

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: SB1578; Drug: Placebo

• Registration Number: NCT01235871
• Lead Sponsor: S*BIO

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-19
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• History or presence of significant disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SB1578	SB1578	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Assess number of participants with adverse events as a measure of safety and tolerability	312 hours postdose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States