A Single and Multiple-Dose Study of SB1578

S*BIO40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

SB1578DRUG

JAK2 Inhibitor

PlaceboDRUG

Control arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 312 hours postdose

Secondary Outcomes

Assess pharmacokinetics to determine study drug half-life, maximum concentration time, elimination time, and area under the curve

Time frame: Predose to 312 hours postdose

Assess pharmacodynamics to determine study drug levels to signal pJAK2, pSTAT3, and pSTAT5

Time frame: Predose, 6 and 24 hours postdose

Assess food effects on pharmacokinetics

Time frame: Predose to 312 hours postdose

Determine recommended dose

Time frame: March 2011

Data from ClinicalTrials.gov

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