A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HighTide Biopharma Pty Ltd

Criteria

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

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