A Single and Multiple-Dose Study of SB1578

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235871

Enrollment

Registered

2010-11-08

Start date

2010-08-31

Completion date

2011-03-31

Last updated

2012-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Safety, Tolerability, SB1578

Brief summary

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

Interventions

DRUGSB1578

JAK2 Inhibitor

DRUGPlacebo

Control arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026