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OpenTrials
Completed

NCT Number: NCT01235871

A Single and Multiple-Dose Study of SB1578

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

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB1578

Drug

JAK2 Inhibitor

Placebo

Drug

Control arm

Primary outcomes

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

    Time frame: 312 hours postdose

Secondary outcomes

  1. 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

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

    Time frame: Predose, 6 and 24 hours postdose

  3. Assess food effects on pharmacokinetics

    Time frame: Predose to 312 hours postdose

  4. Determine recommended dose

    Time frame: March 2011

Sponsors and collaborators

Lead sponsor

S*BIO

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 8, 2010
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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