NCT00979927

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

September 17, 2009

Last Update Submit

October 4, 2011

Conditions

Hepatitis C

Keywords

AntisensemiR-122 antagonistsafety in healthy VolunteersHepatitis C

Outcome Measures

Primary Outcomes (1)

  • Number of subjects experiencing adverse events

    Up to 169 Days

Secondary Outcomes (2)

  • Peak Plasma Concentration (Cmax) of SPC3649

    Up to 169 Days

  • Effect on total Cholesterol

    Up to 169 Days

Study Arms (2)

Saline

PLACEBO COMPARATOR
Drug: saline

SPC3649

ACTIVE COMPARATOR
Drug: SPC3649

Interventions

SPC3649DRUG

5 weekly doses

SPC3649
salineDRUG

5 weekly doses

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA international

Zuidlaren, 9471, Netherlands

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

miravirsenSodium Chloride

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Salah Hadi, MD,MSc

    PRA Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2009

First Posted

September 18, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

NL(1)