Phase 2
Completed N=114
Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)
Source: ClinicalTrials.gov NCT03365947 ↗Enrolled (actual)
114
Serious AEs
3.5%
Results posted
Jun 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment — 1; 1; 1; 1 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment |
1; 1; 1; 1; 1; 5 | — |
| SECONDARY Part A, Pharmacokinetics (PK) of ARO-HBV Analytes: Maximum Observed Plasma Concentration (Cmax) |
160; 536; 1320; 2920; 4280; 43.0 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes : Time to Maximum Plasma Concentration (Tmax) |
6.00; 6.00; 6.00; 6.03; 6.00; 6.00 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) |
1830; 5480; 17800; 35500; 44600; 327 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) |
5820; 12600; 14800; 365; 1530; 4610 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Area Under the Plasma Concentration Versus Time Curve From Zero to the Time of the Last Quantifiable Concentration (AUC0-t) |
1830; 5740; 20100; 37900; 46900; 254 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Terminal Elimination Half-Life (t½) |
6.45; 5.83; 9.16; 7.52; 5.97; 6.48 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-24 |
52.1; 54.8; 88.9; 118; 111; 9.34 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Dose-Normalized AUC0-t |
52.1; 57.4; 101; 126; 117; 7.25 | — |
| SECONDARY Part A, PK of ARO-HBV Analytes: Dose-Normalized Cmax |
4.56; 5.36; 6.58; 9.72; 10.7; 1.23 | — |
| SECONDARY Change From Baseline in HBV Surface Antigen (HBsAg) From Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV |
-1.083; -1.199; -1.695; -1.769; -1.534; -1.889 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03365947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.