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A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Sponsor: HighTide Therapeutics (Hong Kong) Limited
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) profiles of HTD1801 in overweight to obese adults with hypercholesterolemia. There were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with 16 subjects planned for each cohort randomized 3:1 to receive either HTD1801 or Placebo.
Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2018-04-13
Completion Date
2018-12-31
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
HTD1801 Tablets, 500 mg
500 mg/day (250 mg BID)
HTD1801 Tablets, 1000 mg
1000 mg/day (500 mg BID)
HTD1801 Tablets, 2000 mg
2000 mg/day (1000 mg BID)
Placebo to match 500 mg HTD1801
2 tablets/day (1 tablet BID)
Placebo to match 1000 mg HTD1801
4 tablets/day (2 tablet BID)
Placebo to match 2000 mg HTD1801
8 tablets/day (4 tablet BID)
Locations (3)
Q-Pharm Pty Ltd.
Herston, Queensland, Australia
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia