HypercholesterolemiaPhase 1NCT01365663
Multiple Ascending Dose Study of SPC4955 in Healthy Subjects
A Phase 1 study testing SPC4955 and Saline 0.9% in people with Hypercholesterolemia, run by Santaris Pharma A/S at 1 site in Germany.
Trial summary
The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- SPC4955 and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Nov 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects, age 18-65 years, inclusive.
- BMI 18-33 kg/m2
- Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:
- LDL-C ≥3.24 mmol/L (≥125 mg/dL)
- Triglycerides (fasted) <2.7mmol/L (<239 mg/dL)
- ALT within normal limits
Who cannot join
- Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
- History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled
- Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
- Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
- Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies.
- Positive results on the following Screening laboratory tests: urine pregnancy test (women only), alcohol breath test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC4955 Administered to Healthy Subjects
The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.
- Conditions
- Hypercholesterolemia
- Being tested
- SPC4955, Saline 0.9%
- Keywords
- Hypercholesterolemia, LDL, HDL, apoB, hyperlipidemia, LNA-oligonucleotide
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPC4955Drug
3 Weekly SC injections
SPC4955Drug
3 Weekly SC injections
SPC4955Drug
3 Weekly SC injections
SPC4955Drug
3 Weekly SC injections
SPC4955Drug
3 Weekly SC injections
Saline 0.9%Drug
3 Weekly SC injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.25 mg/kg in Healthy Subjects Receives: Drug: SPC4955 |
| Cohort 2 | Experimental | 0.5 mg/kg in Healthy Subjects Receives: Drug: SPC4955 |
| Cohort 3 | Experimental | 1.0 mg/kg in Healthy Subjects Receives: Drug: SPC4955 |
| Cohort 4 | Experimental | 1.5 mg/kg in Healthy Subjects Receives: Drug: SPC4955 |
| Cohort 5 | Experimental | 2.0 mg/kg in Healthy Subjects Receives: Drug: SPC4955 |
| Saline 0.9% | Placebo comparator | Not described Receives: Drug: Saline 0.9% |
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 78 days
Secondary outcomes (5)
Peak Plasma Concentration (Cmax) of SPC4955
Measured: Up to 78 Days
total Cholesterol
Measured: up to 78 days
Area under the plasma concentration versus time curve (AUC) of SPC4955
Measured: Up to 78 days
LDL
Measured: up to 78 days
HDL
Measured: up to 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santaris Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Feuerer, Dr. med., Principal investigator, Nuvisan GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365663
- Sponsor's protocol ID
- SPC4955-901
- Other IDs
- EudraCT 2010-024363-40
- Status last verified
- Jan 2012
- First submitted
- 18 May 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human (FIH), Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPC4955 Administered to Healthy Subjects
- ClinicalTrials.gov ID
- NCT01365663
- Acronym / sponsor ID
- SPC4955-901
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, LDL, HDL, apoB, hyperlipidemia, LNA-oligonucleotide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Santaris Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Jun 2011 (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 study safety and tolerability of SPC4955 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SPC49550.25 mg/kg in Healthy Subjects |
| Cohort 2 | Experimental | Drug: SPC49550.5 mg/kg in Healthy Subjects |
| Cohort 3 | Experimental | Drug: SPC49551.0 mg/kg in Healthy Subjects |
| Cohort 4 | Experimental | Drug: SPC49551.5 mg/kg in Healthy Subjects |
| Cohort 5 | Experimental | Drug: SPC49552.0 mg/kg in Healthy Subjects |
| Saline 0.9% | Placebo comparator | Drug: Saline 0.9% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or female subjects, age 18-65 years, inclusive.
- BMI 18-33 kg/m2
- Screening hematology, clinical chemistries, coagulation and urinalysis consistent with overall good health and the following criteria are met:
Key exclusion criteria (6 listed)
- Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.
- History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled
- Active acute or chronic infection, including, but not limited to: upper airway infection, urinary tract infection, and skin infection
- Use of prescription medication within 14 days prior to the planned first drug administration and throughout the study.
- Use of non-prescription or over-the-counter medications is prohibited within 7 days prior to the planned first drug administration and throughout the study. This includes all vitamins, herbal supplements, or remedies.
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 |
|---|---|---|
| SPC49553 Weekly SC injections | Drug | Cohort 1 |
| SPC49553 Weekly SC injections | Drug | Cohort 2 |
| SPC49553 Weekly SC injections | Drug | Cohort 3 |
| SPC49553 Weekly SC injections | Drug | Cohort 4 |
| SPC49553 Weekly SC injections | Drug | Cohort 5 |
| Saline 0.9%3 Weekly SC injections | Drug | Saline 0.9% |
Primary outcome
Number of subjects experiencing adverse events
Time frame: up to 78 days
5 secondary outcomes
Peak Plasma Concentration (Cmax) of SPC4955
Time frame: Up to 78 Days
total Cholesterol
Time frame: up to 78 days
Area under the plasma concentration versus time curve (AUC) of SPC4955
Time frame: Up to 78 days
LDL
Time frame: up to 78 days
HDL
Time frame: up to 78 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 31 Jan 2012.
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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.
Werner Feuerer, Dr. med. principal investigator
Nuvisan GmbH
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 SPC4955 and Saline 0.9% in people with Hypercholesterolemia, run by Santaris Pharma A/S at 1 site in Germany.
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 6 inclusion and 6 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 31 Jan 2012. 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 Germany. 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 78 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 31 Jan 2012.