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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03381287




Registration number
NCT03381287
Ethics application status
Date submitted
18/12/2017
Date registered
18/12/2017
Date last updated
9/01/2019

Titles & IDs
Public title
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Scientific title
A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia
Secondary ID [1] 0 0
HTD1801.PCT004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HTD1801 Tablets, 500mg
Treatment: Drugs - HTD1801 Tablets, 1000mg
Treatment: Drugs - HTD1801 Tablets, 2000mg

Experimental: 500mg HTD1801 -

Experimental: 1000mg HTD1801 -

Experimental: 2000mg HTD1801 -


Treatment: Drugs: HTD1801 Tablets, 500mg
16 participants will be randomized 3:1 to receive 500mg of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.

Treatment: Drugs: HTD1801 Tablets, 1000mg
16 participants will be randomized 3:1 to receive 1000mg tablets of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.

Treatment: Drugs: HTD1801 Tablets, 2000mg
16 participants will be randomized 3:1 to receive 2000mg of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
frequency and severity of adverse events
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Maximum plasma concentration of HTD1801 components (Cmax)
Timepoint [1] 0 0
4 weeks
Secondary outcome [2] 0 0
Time to Cmax (Tmax)
Timepoint [2] 0 0
4 weeks
Secondary outcome [3] 0 0
change of Low-density lipoprotein-C (LDL-C)
Timepoint [3] 0 0
4 weeks

Eligibility
Key inclusion criteria
1. Have given written informed consent

2. Males or females aged 18 to 70 years old at the time of first dosing

3. Have a body mass index (BMI) of >25.0 and = 45.0 kg/m2 at Screening

4. Have a documented history of hypercholesterolemia, defined as LDL-C = 2.59 mmol/L
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The use of any anti-dyslipidemia agent within 28 days prior to dosing

2. History of a total cholesterol = 10.35 mmol/L or triglyceride = 11.3 mmol/L

3. History of a clinically significant cardiac arrhythmia or clinically significant
abnormal ECG results at Screening

4. Significant peripheral or coronary vascular disease

5. Clinically significant abnormal blood pressure at Screening or Baseline, defined as
supine blood pressure =160/100 mmHg, or = 90/60 mmHg

6. Primary hypothyroidism (thyroid stimulating hormone [TSH] > upper limit or normal
[ULN] and free T4 < lower limit of normal [LLN]), primary subclinical hypothyroidism
(screening TSH > ULN and free T4 within normal limits [WNL]), or secondary
hypothyroidism (screening TSH < LLN and free T4< LLN) at Screening

7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd. - Herston
Recruitment hospital [2] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
HighTide Biopharma Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose
(MAD) study to evaluate the safety and tolerability, PK, and PD profiles of HTD1801 in
overweight to obese adults with hypercholesterolemia. There will be 3 cohorts of dose levels
as 500, 1000 and 2000mg/day, 16 subjects for each cohort with 12 subjects will administer
HTD1801 and 4 subjects will administer Placebo.
Trial website
https://clinicaltrials.gov/show/NCT03381287
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications