NCT03381287

A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: HighTide Biopharma Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	HTD1801 Tablets, 500 mg	500 mg/day (250 mg BID)
DRUG	HTD1801 Tablets, 1000 mg	1000 mg/day (500 mg BID)
DRUG	HTD1801 Tablets, 2000 mg	2000 mg/day (1000 mg BID)
DRUG	Placebo to match 500 mg HTD1801	2 tablets/day (1 tablet BID)
DRUG	Placebo to match 1000 mg HTD1801	4 tablets/day (2 tablet BID)
DRUG	Placebo to match 2000 mg HTD1801	8 tablets/day (4 tablet BID)

Timeline

• Start date: 2018-04-13
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-12-21
• Last updated: 2023-03-03
• Results posted: 2023-03-03

Locations

3 sites across 1 country: Australia