Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

  • STATUS
    Recruiting
  • End date
    Jul 11, 2023
  • participants needed
    128
  • sponsor
    Sunshine Lake Pharma Co., Ltd.
Updated on 2 June 2022
Accepts healthy volunteers

Summary

The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B

Details
Condition Hepatitis B, Chronic
Treatment entecavir tablets, Freethiadine tablets(part I), Freethiadine tablets (part II), Freethiadine placebo tablets
Clinical Study IdentifierNCT05391360
SponsorSunshine Lake Pharma Co., Ltd.
Last Modified on2 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Health volunteer
Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
subjects and must be 18 to 45 years of age inclusive
Body weight ≥ 45 kg and body mass index(BMI)between 18 and 28 kg / m^2, inclusive
Physical examination and vital signs without clinically significant abnormalities
Patients with chronic hepatitis B
Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
subjects and must be 18 to 65 years of age inclusive
Body mass index(BMI)between 18 and 32 kg / m^2, inclusive
No cirrhosis

Exclusion Criteria

Health volunteer
Use of >5 cigarettes per day during the past 3 months
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
Patients with chronic hepatitis B
AFP>50 ng/mL
INR>1.5
Positive for Viral hepatitis C, HIV and syphilis
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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