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A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

NCT03381287 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-03

Study results available
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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

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)

Sponsors & Collaborators

  • HighTide Biopharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Adrian Di Bisceglie, MD,FACP,FAASLD · HighTide Therapeutics USA, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381287 on ClinicalTrials.gov