The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection

Hepatitis C, Chronic Clinical Trial

Official title:

An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774107
• Other study ID #: A20-102
• Status: Completed
• Phase: Phase 1
• Start date: November 26, 2020
• Est. completion date: July 18, 2022

Study information

• Verified date: August 2022
• Source: PharmaEssentia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.

Description:

Secondary Objective:

To determine the safety and immunogenicity of P1101 400 μg subcutaneous (SC) single dose + Ribavirin 800-1400 mg PO daily.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults =18 years of age (or other age required by local regulations); subjects who are over 70 years of age must be in generally good health.

2. Confirmed diagnosis of chronic hepatitis with HCV genotype 2 infection.

3. Compensated liver disease defined by normal or elevated alanine transaminase (ALT) =10 x upper limit of normal (ULN), total bilirubin level <2 mg/dL (except in Gilbert's syndrome), normal albumin, normal international normalized ratio (INR)

4. Interferon treatment naïve: never received any interferon.

5. No other known form of chronic liver disease apart from chronic hepatitis C infection.

6. Hemoglobin 12 g/dL in men or 11 g/dL in women, white blood cell (WBC) count 3,000/mm3, absolute neutrophil count (ANC) 1,500/mm3, platelet count 90,000/mm3; and estimated glomerular filtration rate >60 mL/min.

7. Female and male subjects, and their partners of reproductive potential using effective means of contraception during the whole trial period.

8. Be able to attend all scheduled visits and to comply with all study procedures;

9. Be able to provide written informed consent.

Exclusion Criteria:

1. Decompensated liver disease.

2. Clinically significant illness or surgery within 4 weeks prior to dosing.

3. Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.

4. Positive test for HBsAg or HIV at screening.

5. Clinically significant abnormal vital signs.

6. Evidence of severe retinopathy by fundoscopy except age-related macular degeneration.

7. Significant alcohol or illicit drug abuse within one year prior to the screening visit or refusal to abstain from excessive alcohol consumption as defined above or illicit drugs throughout the study.

8. Pregnant or breast feeding female subjects.

9. Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment.

10. Use of an investigational drug or participation in an investigational drug.

11. Known clinically significant presence of any gastrointestinal pathology, clinically significant unresolved gastrointestinal symptoms, clinically significant liver or clinically significant kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.

12. Clinically significant presence of depression determined by investigators.

13. Clinically significant presence of severe neurological disorders.

14. Clinically significant presence of severe cardiovascular conditions and severe pulmonary conditions, uncontrolled immunologic, uncontrolled autoimmune, uncontrolled endocrine, uncontrolled metabolic, haematological, severe coagulation disorders or severe blood dyscrasias or other severe uncontrolled systemic disease.

15. A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception or hyaluronic acid injections in joints for osteoarthritis;

16. Body organ transplant and are taking immunosuppressants;

17. History of malignant disease, including solid tumors and hematologic malignancies. However, subjects who are cancer survivors not on maintenance therapy and who had no malignant diseases history within the past 5 years could be recruited.

18. History of or ongoing opportunistic infection.

19. Serious local infection or systemic infection.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• P1101 + Ribavirin
P1101 400 µg SC

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Chiayi Branch	Chiayi City
Taiwan	Chia-Yi Christian Hospital	Chiayi City
Taiwan	St. Martin De Porres Hospital	Chiayi City
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Chi Mei Medical Center	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
PharmaEssentia

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of P1101 in the blood stream	The measurement of P1101 levels in the blood stream over time. The sampling time points are 0 hour before the first dose, 24±4 hours, 48±4 hours, 72±4 hours, 96±4 hours, 168±4 hours, 216±4 hours, 264±4 hours and 336±4 hours after first dose. PK sampling at 504±4 hours and 672±4 hours after first dose are optional.	2-4 weeks
Secondary	Adverse Events	To evaluate the safety of P1101 by the proportion of adverse events	2-4 weeks
Secondary	Abnormal Laboratory Assessments	To evaluate the safety of P1101 by the proportion of abnormal laboratory assessments	2-4 weeks
Secondary	Positive anti-drug antibodies	To evaluate the positive anti-drug antibodies of P1101 by the proportion	2-4 weeks
Secondary	Positive neutralizing antibody	To evaluate the positive neutralizing antibody of P1101 by the proportion	2-4 weeks