A First In Human Study to Assess CiVi007 in Subjects With an Elevated LDL-Cholesterol Level

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03427710

Enrollment

Registered

2018-02-09

Start date

2018-02-07

Completion date

2020-08-18

Last updated

2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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

Interventions

DRUGCiVi007

cholesterol lowering drug

OTHERPlacebo

matching placebo to CiVi007

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Adaptive design allowing modifications in single and multidose arms

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Key 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. Key

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 * History of multiple drug allergies or intolerance to subcutaneous injection.

Design outcomes

Primary

Measure	Time frame	Description
LDL Cholesterol	Maximum post dose within 8 weeks	% LDL-C reduction

Secondary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax) of CiVi007	8 weeks	Pharmacokinetic Outcome Measure
PCSK9 level	Maximum post dose within 8 weeks	maximal % reduction in the level of circulating PCSK9

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026