SPC3649 Multiple Dose Study in Healthy Volunteers

A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00979927

Enrollment

Registered

2009-09-18

Start date

2009-09-30

Completion date

2010-09-30

Last updated

2011-10-05

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

Conditions

Hepatitis C

Keywords

Antisense, miR-122 antagonist, safety in healthy Volunteers, Hepatitis C

Brief summary

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

Interventions

DRUGSPC3649

5 weekly doses

DRUGsaline

5 weekly doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Number of subjects experiencing adverse events	Up to 169 Days

Secondary

Measure	Time frame
Peak Plasma Concentration (Cmax) of SPC3649	Up to 169 Days
Effect on total Cholesterol	Up to 169 Days

Countries

Netherlands

Outcome results

None listed

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