NCT03427710
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- CiVi007
- Conditions
- Hypercholesterolemia
- Sponsor
- Civi Biopharma, Inc.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- LDL Cholesterol
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •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
Arms & Interventions
Cohort A1
CiVi007 dose 1
Intervention: CiVi007
Cohort A2
CiVi007 dose 2
Intervention: CiVi007
Cohort A3
CiVi007 dose 3
Intervention: CiVi007
Cohort A4
CiVi007 dose 4
Intervention: CiVi007
Cohort A5
CiVi007 dose 5
Intervention: CiVi007
Combined placebo group
group response from placebo subsets of dosing cohorts
Intervention: Placebo
Outcomes
Primary Outcomes
LDL Cholesterol
Time Frame: Maximum post dose within 8 weeks
% LDL-C reduction
Secondary Outcomes
- Peak Plasma Concentration (Cmax) of CiVi007(8 weeks)
- PCSK9 level(Maximum post dose within 8 weeks)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese VolunteersHealthy VolunteerNCT06632938AbbVie24
Completed
Phase 1
IAMA-6 Oral Dose Study in Healthy AdultsNeurodevelopmental DisordersNCT06300398Iama Therapeutics S.r.l.72
Completed
Phase 1
A Study to Test How Well Different Doses of BI 765845 Are Tolerated by Healthy PeopleHealthyNCT06139315Boehringer Ingelheim92
Completed
Phase 1
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal DysfunctionHeart FailureKidney DiseaseNCT01444872Trevena Inc.17
Completed
Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671HyperuricemiaGoutNCT04060173Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.27