Hepatitis CPhase 1NCT00979927
SPC3649 Multiple Dose Study in Healthy Volunteers
A Phase 1 study testing SPC3649 and saline in people with Hepatitis C, run by Santaris Pharma A/S at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- SPC3649 and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.
- Conditions
- Hepatitis C
- Being tested
- SPC3649, saline
- Keywords
- Antisense, miR-122 antagonist, safety in healthy Volunteers, Hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC3649Drug
5 weekly doses
salineDrug
5 weekly doses
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: saline |
| SPC3649 | Active comparator | Not described Receives: Drug: SPC3649 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing adverse events
Measured: Up to 169 Days
Secondary outcomes (2)
Peak Plasma Concentration (Cmax) of SPC3649
Measured: Up to 169 Days
Effect on total Cholesterol
Measured: Up to 169 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santaris Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Salah Hadi, MD,MSc, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979927
- Sponsor's protocol ID
- SPC3649-202
- Other IDs
- Eudract no 2009-012153-38
- Status last verified
- Oct 2011
- First submitted
- 17 Sep 2009
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
- ClinicalTrials.gov ID
- NCT00979927
- Acronym / sponsor ID
- SPC3649-202
- Conditions
- Hepatitis C
- Keywords
- Antisense, miR-122 antagonist, safety in healthy Volunteers, Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Santaris Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: saline |
| SPC3649 | Active comparator | Drug: SPC3649 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPC36495 weekly doses | Drug | SPC3649 |
| saline5 weekly doses | Drug | Saline |
Primary outcome
Number of subjects experiencing adverse events
Time frame: Up to 169 Days
2 secondary outcomes
Peak Plasma Concentration (Cmax) of SPC3649
Time frame: Up to 169 Days
Effect on total Cholesterol
Time frame: Up to 169 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Hadi, MD,MSc principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPC3649 and saline in people with Hepatitis C, run by Santaris Pharma A/S at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects experiencing adverse events (time frame: Up to 169 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.