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Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by LipimetiX Development, LLC
Sponsor:
Information provided by (Responsible Party):
LipimetiX Development, LLC
ClinicalTrials.gov Identifier:
NCT02100839
First received: March 27, 2014
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated.

The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia.

AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.


Condition Intervention Phase
Hypercholesterolemia
Hyperlipoproteinemia Type II
Drug: AEM-28
Drug: Normal Saline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AEM-28 in Healthy Subjects and Patients With Refractory Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by LipimetiX Development, LLC:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: From 1st dose, Day 1, to Day 8 for SAD study; From 1st dose, Day 1, to Day 57 for MAD study ] [ Designated as safety issue: Yes ]
    Assessment of adverse events (i.e. seriousness, severity, relationship to AEM-28), vital signs, ECG, clinical laboratory parameters, physical examinations, local response to each injection and body weight.


Estimated Enrollment: 51
Study Start Date: March 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AEM-28

Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL

Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.

Drug: AEM-28
Solution for injection
Other Name: apolipoprotein E mimetic
Placebo Comparator: Normal Saline

Single Ascending Dose: Single IV dose for each cohort.

Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.

Drug: Normal Saline
0.9% saline for injection
Other Names:
  • 0.9% NaCl
  • Sterile Normal Saline

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

SAD Study:

  • Male or female non-smoker, ≥18 and ≤55 years of age, with BMI >18.5 and < 32.0 kg/m²
  • Total cholesterol greater or equal to 5.0 mmol/L (≥194 mg/dL) at screening

MAD Study:

  • Male or female non-smoker, ≥18 and ≤75 years of age, with BMI >18.5 and < 35.0 kg/m²
  • Diagnosis of refractory hypercholesterolemia with LDL cholesterol levels > 2.5 mmol/L (97 mg/mL) at screening.
  • On stable lipid lowering therapy for ≥ 8 weeks
  • On stable diet for ≥ 12 weeks.

Exclusion Criteria:

SAD Study:

  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
  • History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.

MAD Study:

  • Significant health problems within 6 months prior to screening, which in the opinion of the Medical Sub-Investigator would prevent the subject from participating in the study, including but not limited to: unstable coronary heart disease; transient ischemic attack; stroke; revascularization procedure; uncontrolled hyperthyroidism; coagulation disorder; peptic ulcers or GI bleeding; significant disease of the central nervous system; liver or renal disease.
  • History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02100839

Locations
Australia, Western Australia
Linear Clinical Research Ltd. Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Janakan Krishnarajah, MBBS, FRACP    +61 8 6382 5100    contactus@linear.org.au   
Principal Investigator: Janakan Krishnarajah, MBBS, FRACP         
Sponsors and Collaborators
LipimetiX Development, LLC
Investigators
Principal Investigator: Janakan Krishnarajah, MBBS, FRACP Linear Clinical Research Ltd.
  More Information

No publications provided

Responsible Party: LipimetiX Development, LLC
ClinicalTrials.gov Identifier: NCT02100839     History of Changes
Other Study ID Numbers: LPMX-112
Study First Received: March 27, 2014
Last Updated: April 1, 2014
Health Authority: Australia: Therapeutic Goods Administration

Keywords provided by LipimetiX Development, LLC:
hypercholesterolemia
apolipoprotein E
First in Human
ApoE

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 24, 2014