Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02100839
Registration number
NCT02100839
Ethics application status
Date submitted
27/03/2014
Date registered
1/04/2014
Date last updated
29/12/2015
Titles & IDs
Public title
Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
LPMX-112
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
0
0
Query!
Hyperlipoproteinemia Type II
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Other metabolic disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - AEM-28
Treatment: Drugs - Normal Saline
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.
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.
Treatment: Drugs: AEM-28
Solution for injection
Treatment: Drugs: Normal Saline
0.9% saline for injection
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants Who Incurred at Least One Treatment Emergent Event
Query!
Assessment method [1]
0
0
Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
Query!
Timepoint [1]
0
0
Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
Query!
Primary outcome [2]
0
0
Number of Participants Who Incurred Mild Treatment Emergent Adverse Events
Query!
Assessment method [2]
0
0
Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
Query!
Timepoint [2]
0
0
Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
Query!
Primary outcome [3]
0
0
Number of Participants Who Incurred Moderate Treatment Emergent Events
Query!
Assessment method [3]
0
0
Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.
Safety and tolerability data were reported using descriptive statistics.
Query!
Timepoint [3]
0
0
Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57
Query!
Secondary outcome [1]
0
0
Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change
Query!
Assessment method [1]
0
0
Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.
Query!
Timepoint [1]
0
0
Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57
Query!
Eligibility
Key inclusion criteria
Single Ascending Dose (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
Multiple Ascending Dose (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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2014
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
52
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
Linear Clinical Research Ltd. - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
6009 - Nedlands
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
LipimetiX Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02100839
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janakan Krishnarajah, MBBS, FRACP
Query!
Address
0
0
Linear Clinical Research
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02100839
Download to PDF