HypercholesterolemiaPhase 1NCT03427710
A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level
A Phase 1 study testing CiVi007 in people with Hypercholesterolemia, run by Civi Biopharma, Inc. at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- CiVi007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Feb 2018to 18 Aug 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any race, with fasting LDL C >2.6 mmol/L (100 mg/dL) and fasting serum triglycerides <4.52 mmol/L (400 mg/dL)
- haematology and clinical chemistry without clinically significant abnormal values
- Normal renal and hepatic function
- Women must not be pregnant, lactating or of child bearing potential
- Men must be willing to use appropriate contraception during the study
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- Any uncontrolled or serious disease, or any medical or surgical condition
- History or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Secondary dyslipidemia
- History of renal or hepatic diseases, acquired immune deficiency syndrome, positive human immunodeficiency virus test and/or history of viral hepatitis B or C
Show all 11Show fewer
- History of cancer within 5 years
- History of high alcohol consumption or positive alcohol breath test or urinary test for drugs of abuse
- Participation in another clinical study within 3 months prior to screening or participation in another study
- Use of treatment (e.g. antibody) towards PCSK9
- History of multiple drug allergies or intolerance to subcutaneous injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Single Blind, Randomised, Phase I, First In Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CiVi007 in Subjects With an Elevated LDL C Level
The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
- Conditions
- Hypercholesterolemia
- Being tested
- CiVi007, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiVi007Drug
cholesterol lowering drug
PlaceboOther
matching placebo to CiVi007
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 | Experimental | CiVi007 dose 1 Receives: Drug: CiVi007 |
| Cohort A2 | Experimental | CiVi007 dose 2 Receives: Drug: CiVi007 |
| Cohort A3 | Experimental | CiVi007 dose 3 Receives: Drug: CiVi007 |
| Cohort A4 | Experimental | CiVi007 dose 4 Receives: Drug: CiVi007 |
| Cohort A5 | Experimental | CiVi007 dose 5 Receives: Drug: CiVi007 |
| Combined placebo group | Placebo comparator | group response from placebo subsets of dosing cohorts Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL Cholesterol
% LDL-C reduction
Measured: Maximum post dose within 8 weeks
Secondary outcomes (2)
Peak Plasma Concentration (Cmax) of CiVi007
Pharmacokinetic Outcome Measure
Measured: 8 weeks
PCSK9 level
maximal % reduction in the level of circulating PCSK9
Measured: Maximum post dose within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start7 Feb 2018
- Primary completion14 Feb 2020
- Study completion18 Aug 2020
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
- Model description
- Adaptive design allowing modifications in single and multidose arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Civi Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MBChB, PhD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427710
- Sponsor's protocol ID
- CiVi-001
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2018
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single Blind, Randomised, Phase I, First In Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered CiVi007 in Subjects With an Elevated LDL C Level
- ClinicalTrials.gov ID
- NCT03427710
- Acronym / sponsor ID
- CiVi-001
- Conditions
- Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Civi Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 9 Feb 2018 (actual)
- 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 primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Adaptive design allowing modifications in single and multidose arms
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 | Experimental | Drug: CiVi007CiVi007 dose 1 |
| Cohort A2 | Experimental | Drug: CiVi007CiVi007 dose 2 |
| Cohort A3 | Experimental | Drug: CiVi007CiVi007 dose 3 |
| Cohort A4 | Experimental | Drug: CiVi007CiVi007 dose 4 |
| Cohort A5 | Experimental | Drug: CiVi007CiVi007 dose 5 |
| Combined placebo group | Placebo comparator | Other: Placebogroup response from placebo subsets of dosing cohorts |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females, of any race, with fasting LDL C >2.6 mmol/L (100 mg/dL) and fasting serum triglycerides <4.52 mmol/L (400 mg/dL)
- haematology and clinical chemistry without clinically significant abnormal values
- Normal renal and hepatic function
- Women must not be pregnant, lactating or of child bearing potential
- Men must be willing to use appropriate contraception during the study
Key exclusion criteria (11 listed)
- Any uncontrolled or serious disease, or any medical or surgical condition
- History or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease
- Uncontrolled hypertension
- Insulin dependent diabetes mellitus
- Secondary dyslipidemia
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 |
|---|---|---|
| CiVi007cholesterol lowering drug | Drug | Cohort A1, Cohort A2, Cohort A3, Cohort A4, Cohort A5 |
| Placebomatching placebo to CiVi007 | Other | Combined placebo group |
Primary outcome
LDL Cholesterol
Time frame: Maximum post dose within 8 weeks
% LDL-C reduction
2 secondary outcomes
Peak Plasma Concentration (Cmax) of CiVi007
Time frame: 8 weeks
PCSK9 level
Time frame: Maximum post dose within 8 weeks
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 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
Jim Bush, MBChB, PhD principal investigator
Covance
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 CiVi007 in people with Hypercholesterolemia, run by Civi Biopharma, Inc. at 1 site in United Kingdom.
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 11 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 22 Sep 2020. 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 United Kingdom. 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?
LDL Cholesterol (time frame: Maximum post dose within 8 weeks). 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 22 Sep 2020.