The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: HEC110114 tablet; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03903081

HEC110114-P-01

Details and patient eligibility

About

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects

Enrollment: 93 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
• Be able to complete the study according to the trail protocol
• Subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures
• Male subjects and must be 18 to 45 years of age inclusive
• Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg/m2, inclusive
• Physical examination and vital signs without clinically significant abnormalities.

Exclusion criteria

• Use of >5 cigarettes per day during the past 3 months
• Allergies constitution ( multiple drug and food allergies)
• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
• Donation or loss of blood over 450 mL within 3 months prior to screening
• 12-lead ECG with clinically significant
• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
• Subjects deemed unsuitable by the investigator for any other reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 10 patient groups

100 mg single dose

Experimental group

Description:

It includes two groups, one group is pilot study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=2) . Another group is formal study, healthy subjects receive a single dose of 100 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

300 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 300 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

600 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 600 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

800 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 800 mg HEC110114 tablet (N=16) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

1000 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 1000 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

1200 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 1200 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

1600 mg single dose

Experimental group

Description:

Healthy subjects, receiving a single dose of 1600 mg HEC110114 tablet (N=8) or matching placebo (N=2)

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

600 mg multiple doses

Experimental group

Description:

Healthy subjects, receiving 600 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

800 mg multiple doses

Experimental group

Description:

Healthy subjects, receiving 800 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet

1000 mg multiple doses

Experimental group

Description:

Healthy subjects, receiving 1000 mg HEC110114 tablet (N=10) or placebo(N=2) once daily (q.d.) for 7 days

Treatment:

Drug: Placebo Oral Tablet

Drug: HEC110114 tablet