Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Status and phase
Completed
Phase 2
Phase 1
Conditions
Hepatitis B
Treatments
Drug: JNJ-56136379
Other: Sterile Normal Saline (0.9% NaCl)
Drug: ARO-HBV
Details and patient eligibility
About
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).
Enrollment
114 patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria for Parts A & B:
- Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception.
- Willing to provide written informed consent and comply with study requirements
Additional Inclusion Criteria for Part B:
- Diagnosis of chronic HBV infection
- Hepatitis B surface antigen (HbsAg) at screening > or = 50 IU/mL
- Liver Elastography score < or = 10.5
Exclusion Criteria:
- Clinically significant health concerns (with the exception of HBV for Patients in Part B)
- Abnormal for any clinical safety laboratory result considered clinically significant
- Regular use of alcohol within 1 month prior to screening
- Recent use of illicit drugs
- Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
NOTE: additional inclusion/exclusion criteria may apply, per protocol
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
114 participants in 19 patient groups, including a placebo group
ARO-HBV 35 mg
Experimental group
Description:
Single dose of ARO-HBV 35 mg subcutaneous (sc) injection in normal healthy volunteers
Treatment:
Drug: ARO-HBV
ARO-HBV 100 mg
Experimental group
Description:
Single dose of ARO-HBV 100 mg sc injection in normal healthy volunteers
Treatment:
Drug: ARO-HBV
ARO-HBV 200 mg
Experimental group
Description:
Single dose of ARO-HBV 200 mg sc injection in normal healthy volunteers
Treatment:
Drug: ARO-HBV
ARO-HBV 300 mg
Experimental group
Description:
Single dose of ARO-HBV 300 mg sc injection in normal healthy volunteers
Treatment:
Drug: ARO-HBV
ARO-HBV 400 mg
Experimental group
Description:
Single dose of ARO-HBV 400 mg sc injection in normal healthy volunteers
Treatment:
Drug: ARO-HBV
Placebo
Placebo Comparator group
Description:
Sterile normal saline (0.9% NaCl) sc injection in normal healthy volunteers
Treatment:
Other: Sterile Normal Saline (0.9% NaCl)
ARO-HBV 25 mg, Q28D
Experimental group
Description:
ARO-HBV 25 mg sc injection every 28 days (Q28D) in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 50 mg Q28D
Experimental group
Description:
ARO-HBV 50 mg sc injection Q28D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 100 mg Q28D
Experimental group
Description:
ARO-HBV 100 mg sc injection Q28D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 200 mg Q28D
Experimental group
Description:
ARO-HBV 200 mg sc injection Q28D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 300 mg Q28D
Experimental group
Description:
ARO-HBV 300 mg sc injection Q28D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 400 mg Q28D
Experimental group
Description:
ARO-HBV 400 mg sc injection Q28D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 100 mg Q14D
Experimental group
Description:
ARO-HBV 100 mg sc injection every 14 days (Q14D) in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 100 mg Q7D
Experimental group
Description:
ARO-HBV 100 mg sc injection every 7 days (Q7D) in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 300 mg, Q28D, HBeAg+/ Trt Naïve
Experimental group
Description:
ARO-HBV 300 mg sc injection Q28D in hepatitis B e antigen positive/treatment naïve (HBeAg+/Trt Naïve) participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 300 mg, Q28D, HBeAg+/ NUC
Experimental group
Description:
ARO-HBV 300 mg sc injection Q28D in HBeAg+/nucleotide or nucleoside analog treated (HBeAg+/NUC) participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 200 mg, Q7D
Experimental group
Description:
ARO-HBV 200 mg sc injection Q7D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 300 mg, Q7D
Experimental group
Description:
ARO-HBV 300 mg sc injection Q7D in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
ARO-HBV 200 mg Q28D + JNJ-56136379 250 mg
Experimental group
Description:
ARO-HBV 200 mg sc injection Q28D plus JNJ-56136379 250 mg in participants with chronic hepatitis B
Treatment:
Drug: ARO-HBV
Drug: JNJ-56136379
Trial contacts and locations
7
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Data sourced from clinicaltrials.gov
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