The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects

NCT04202952 | Completed Phase 1

• 1 other identifier: HEC110114-P-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ib/IIa, Single Center, Randomized, open, Sofosbuvir-controlled, Multiple Ascending Dose Study to Access the Tolerability，Pharmacokinetics and Pharmacodynamics of HEC110114 Tablets in HCV-infected Subjects

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Incidence of adverse events

  From Days 1-10

Secondary Outcomes (5)

• Cmax

  At pre-defined intervals from Days 1-7

• Tmax

  At pre-defined intervals from Days 1-7

• T1/2 T1/2 T1/2 T1/2

  At pre-defined intervals from Days 1-7

• AUClast

  At pre-defined intervals from Days 1-7

• HCV RNA

  At pre-defined intervals from Days 1-10

Study Arms (3)

600 mg multiple doses

EXPERIMENTAL

Subjects receiving 600 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Drug: HEC110114 Tablet; Drug: Sofosbuvir Tablet

800 mg multiple doses

EXPERIMENTAL

Subjects receiving 800 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Drug: HEC110114 Tablet; Drug: Sofosbuvir Tablet

1200 mg multiple doses

EXPERIMENTAL

Subjects receiving 1200 mg HEC110114 tablet (N=6) or sofosbuvir tablets(N=2) once daily (q.d.) for 3 days

Drug: Sofosbuvir Tablet

Interventions

HEC110114 Tablet DRUG

administered orally once daily

600 mg multiple doses; 800 mg multiple doses

Sofosbuvir Tablet DRUG

administered orally once daily

1200 mg multiple doses; 600 mg multiple doses; 800 mg multiple doses

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 65 years of age inclusive;
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females;
• No previous treatment with any direct-acting antiviral (DAA) drugs for HCV, such as Simeprevir, Sofosbuvir, Daclatasvir etc;
• HCV RNA ≥10\*5 IU/mL at screening (Roche COBAS Taqman);
• Chronic genotype 1-6 HCV Infection, multiple genotypes, subtype unidentifiable or others ;
• Serum ALT ≤5 times ULN.

You may not qualify if:

• 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;
• History of any non-HCV liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc;
• lead ECG with clinically significant;
• Pregnant or lactating women;
• Creatinine clearance \< 60 mL/min;
• Subjects deemed unsuitable by the investigator for any other reason.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Jilin, Changchun, 130021, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Junqi Niu, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

• Yanhua Ding, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: July 6, 2020
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: September 10, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)