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COMPLETED
NCT03381287
PHASE1/PHASE2

A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

Sponsor: HighTide Therapeutics (Hong Kong) Limited

View on ClinicalTrials.gov

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

Interventions

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)

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