CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
HTD1801 Tablets, 500 mg +5 moredrug
Likely dose
HTD1801 Tablets, 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03381287
NCT03381287Phase 2Completed
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A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia

HighTide Biopharma Pty Ltd·interventional·Posted Dec 21, 2017·Updated Mar 3, 2023

In Brief

A Phase 2 clinical trial evaluating HTD1801 Tablets, 500 mg, HTD1801 Tablets, 1000 mg, and 4 other interventions for Hypercholesterolemia. Completed, enrolled 50 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypercholesterolemia
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 21, 2017
Enrollment StartApr 13, 2018
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.5 years ago

Interventions

HTD1801 Tablets, 500 mgdrug

500 mg/day (250 mg BID)

HTD1801 Tablets, 1000 mgdrug

1000 mg/day (500 mg BID)

HTD1801 Tablets, 2000 mgdrug

2000 mg/day (1000 mg BID)

Placebo to match 500 mg HTD1801drug

2 tablets/day (1 tablet BID)

Placebo to match 1000 mg HTD1801drug

4 tablets/day (2 tablet BID)

Placebo to match 2000 mg HTD1801drug

8 tablets/day (4 tablet BID)