A Single and Multiple-Dose Study of SB1578

S*BIO

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: SB1578

Study type: Interventional

Funder types: Industry

Identifiers

NCT01235871

SB1578-2010-001

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

SB1578

Experimental group

Treatment:

Drug: SB1578

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo