Status:
COMPLETED
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Lead Sponsor:
HighTide Biopharma Pty Ltd
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile...
Eligibility Criteria
Inclusion
- Have given written informed consent
- Males or females aged 18 to 70 years old at the time of first dosing
- Have a body mass index (BMI) of \>25.0 and ≤ 45.0 kg/m2 at Screening
- Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L
Exclusion
- The use of any anti-dyslipidemia agent within 28 days prior to dosing
- History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L
- History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
- Significant peripheral or coronary vascular disease
- Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg
- 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
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03381287
Start Date
April 13 2018
End Date
December 31 2018
Last Update
March 3 2023
Active Locations (3)
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1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia, 4006
2
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia, 5000
3
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009