A Phase 1, Placebo-controlled, First-in-human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After a Single Dose and Multiple Doses in Healthy Subjects

Phase 1

Completed

• Conditions: Chronic Hepatitis B; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000592842
• Lead Sponsor: Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Study Completion: 2022-11-30
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Female subjects must have a negative serum pregnancy test and must not be of childbearing potential
Male subjects must be either surgically sterile, or incapable of fathering a child, or have a heterosexual partner partner who is not pregnant or of childbearing potential
Nonsmoker within last 3 months
BMI of 18.0 to 32.0 kg/m2
Subjects must be deemed healthy by the Investigator on the basis of a medical evaluation

Exclusion Criteria

Evidence of clinically significant cardiac history
Personal or family history of chronic inflammatory skin disease or immune or autoimmune related disorders, diseases or syndromes
History or current evidence of use of amphetamines, barbiturates, narcotic or other drugs of abuse/recreational drug use, except under physician supervision
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
Subjects with current hepatitis A, B, C, D, E, HIV, infection or acute infection such as SARS-CoV-2 (COVID-19)
Subjects with kidney disease or significant abnormal vital signs

Study & Design

• Study Type: Interventional
• Study Design: Not specified