A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Doses in Chronic Hepatitis B subjects
- Conditions
- Chronic Hepatitis BInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12623000997651
- Lead Sponsor
- Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
1) Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
2) In the Investigator’s opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
3) Female subjects must NOT be of childbearing potential, which is defined as postmenopausal or permanently sterile, OR, if they are a woman of childbearing potential (WOCBP), must agree to use a condom and/or highly effective contraceptive therapy.
4) Male subjects must be either surgically sterile (eg, had a vasectomy), or otherwise incapable of fathering a child; OR, if non-sterile and heterosexually active, must have a partner who is postmenopausal, surgically sterile; OR, if their partner is WOCBP, must use highly effective methods of contraception from the time of male subject's Screening until at least 90 days after the last dose of study drug.
5) Subjects must have a BMI of 18.0 to 35.0 kg/m^2.
6) Subjects must have CHB infection documented by serum HBsAg-positive at Screening and at least 6 months prior to Screening.
1) Evidence of clinically significant cardiac history
2) Personal or family history of chronic inflammatory skin disease or immune or autoimmune related disorders, diseases or syndromes
3) History or current evidence of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use, except under physician supervision
4) Excessive use of alcohol and unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow-up
5) Subjects with kidney disease or significant abnormal vital signs
6) Female subjects who are pregnant, breastfeeding, or planning to become pregnant while on study medication or within 90 days after the last dose of study drug
7) Subjects positive for anti-HBs
8) Subjects with any history or current evidence of hepatic decompensation
9) History or current evidence of hepatic decompensation, cirrhosis, liver fibrosis, or hepatocellular carcinoma
10) Subjects with liver disease of non-HBV etiology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method