SPC3649 Multiple Dose Study in Healthy Volunteers

Santaris Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: SPC3649; Drug: saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979927

Eudract no 2009-012153-38

SPC3649-202

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Treatment:

Drug: saline

SPC3649

Active Comparator group

Treatment:

Drug: SPC3649