CompletedPhase 1ACTRN12621000592842

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

A Phase 1, Double-blind, Randomized, 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 of Orally Administered DF 006 in Healthy Subjects (Part 1 and Part 2)

Sponsor

Zhejiang Yao Yuan Biotechnology Ltd. (Drug Farm)

Enrollment

34 participants

Start Date

Jul 16, 2021

Study Type

Interventional

Conditions

Chronic Hepatitis B

Summary

Drug Farm is developing an investigational drug called DF-006, to treat chronic hepatitis B. DF-006 is a drug that attaches to a protein in the cell know as Alpha-1 kinase (ALPK1). In the liver, upon attaching to ALPK1, there is an activation of the body’s immune system that leads to the expression of many immune-related proteins known as chemokines and cytokines. These chemokines and cytokines are thought to play a role at various stages of hepatitis B virus (HBV) lifecycle, ultimately leading to reductions in viral (1) replication, (2) immunosuppressive proteins and, (3) genetic material. The study has two main aims: • To see if DF-006 is safe and well-tolerated in healthy adults. • To measure levels of DF-006, and compounds related to DF-006, in the blood over time, following multiple doses of DF-006. The study will also look at: • Whether or not ethnicity affects the levels of DF-006 in the blood. • Whether DF-006 is processed and cleared differently in people of Asian ethnicity. • If certain markers in your blood show that DF-006 is working as predicted.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria5

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 Criteria6

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

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Interventions

Healthy subjects in Part 1 will receive a single oral liquid dose of DF-006, starting at 3mcg, for one day. Subsequent doses will be based on safety data from prior patients and cohorts. Healthy sub

Healthy subjects in Part 1 will receive a single oral liquid dose of DF-006, starting at 3mcg, for one day. Subsequent doses will be based on safety data from prior patients and cohorts. Healthy subjects in Part 2 will receive a single oral liquid dose of DF-006 weekly for 14 days, starting at the dose determined in Part 1. Participants in Part 2 are likely to be different from participants in Part 1. A Study Safety Committee will provide safety oversight and will follow Dose Selection Guidelines to determine cohort doses. Cohort progression will be based on Data Review Meetings. In Part 1, cohort progression will occur approximately every 3 weeks. In Part 2, cohort progression will occur approximately every 4 weeks. Adherence to the intervention will be monitored by direct observation of dosing.