A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HTD1801 250 mg BID

Subjects received 500 mg/day HTD1801

Group Type EXPERIMENTAL

HTD1801 Tablets, 500 mg

Intervention Type DRUG

500 mg/day (250 mg BID)

HTD1801 500 mg BID

Subjects received 1000 mg/day HTD1801

Group Type EXPERIMENTAL

HTD1801 Tablets, 1000 mg

Intervention Type DRUG

1000 mg/day (500 mg BID)

HTD1801 1000 mg BID

Subjects received 2000 mg/day HTD1801

Group Type EXPERIMENTAL

HTD1801 Tablets, 2000 mg

Intervention Type DRUG

2000 mg/day (1000 mg BID)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo to match 500 mg HTD1801

Intervention Type DRUG

2 tablets/day (1 tablet BID)

Placebo to match 1000 mg HTD1801

Intervention Type DRUG

4 tablets/day (2 tablet BID)

Placebo to match 2000 mg HTD1801

Intervention Type DRUG

8 tablets/day (4 tablet BID)

Interventions

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HTD1801 Tablets, 500 mg

500 mg/day (250 mg BID)

Intervention Type DRUG

HTD1801 Tablets, 1000 mg

1000 mg/day (500 mg BID)

Intervention Type DRUG

HTD1801 Tablets, 2000 mg

2000 mg/day (1000 mg BID)

Intervention Type DRUG

Placebo to match 500 mg HTD1801

2 tablets/day (1 tablet BID)

Intervention Type DRUG

Placebo to match 1000 mg HTD1801

4 tablets/day (2 tablet BID)

Intervention Type DRUG

Placebo to match 2000 mg HTD1801

8 tablets/day (4 tablet BID)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Have given written informed consent
2. Males or females aged 18 to 70 years old at the time of first dosing
3. Have a body mass index (BMI) of \>25.0 and ≤ 45.0 kg/m2 at Screening
4. Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L

Exclusion Criteria

1. The use of any anti-dyslipidemia agent within 28 days prior to dosing
2. History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L
3. History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
4. Significant peripheral or coronary vascular disease
5. Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg
6. Primary hypothyroidism (thyroid stimulating hormone \[TSH\] \> upper limit or normal \[ULN\] and free T4 \< lower limit of normal \[LLN\]), primary subclinical hypothyroidism (screening TSH \> ULN and free T4 within normal limits \[WNL\]), or secondary hypothyroidism (screening TSH \< LLN and free T4\< LLN) at Screening
7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No