Trial reportHepatology international2026
Safety, pharmacokinetics and antiviral activity of AHB‑137 in healthy volunteers and chronic hepatitis B patients: a phase 1a/1b study.
Trial report in Hepatology international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06115993 (A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Single Ascending Doses and Multiple Doses of AHB-137 in Healthy Participants and HBeAg-negative CHB Patients Receiving Stable Nucleos), which is not on this map. Not yet cited in PubMed.
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A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Single Ascending Doses and Multiple Doses of AHB-137 in Healthy Participants and HBeAg-negative CHB Patients Receiving Stable Nucleos(t)Ide Analogues (NAs) Treatment
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22 authors.
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Abstract
background/purposeAHB-137 is a novel antisense oligonucleotide targeting a conserved 3'-terminal region of HBV mRNA. This phase 1a/1b study evaluated the safety, pharmacokinetics (PK), and antiviral activity of AHB-137 in Chinese healthy volunteers (HVs) and chronic hepatitis B (CHB) patients.
methodsIn Phase 1a, 52 HVs received single ascending doses (75-450 mg) or multiple ascending doses (MAD; 150 or 300 mg) of AHB-137 or placebo. In Phase 1b, 20 HBeAg-negative, nucleos(t)ide analogue (NA)-suppressed CHB patients with baseline HBsAg 100-1000 IU/mL received MAD AHB-137 (150 or 300 mg) or placebo (8:2), and 2 patients with baseline HBsAg 1000-3000 IU/mL received open-label AHB-137 300 mg. MAD comprised 6 subcutaneous doses over 4 weeks including loading doses on Days 4 and 11, with safety, PK and virologic follow-up assessments.
resultsNo serious adverse events, deaths or discontinuations occurred. Most treatment-related adverse events were Grade 1-2, including injection site reactions, pyrexia, and asymptomatic lab abnormalities. Transaminase elevations were self-limiting; one Grade 3 ALT elevation in the 300 mg CHB cohort coincided with rapid HBsAg loss. PK showed rapid absorption (T
conclusionAHB-137 demonstrated favorable safety, predictable PK, and dose-dependent HBsAg reductions, including HBsAg loss, supporting its further development for CHB functional cure. REGISTRATION NUMBER: ClinicalTrials.gov. number: NCT06115993. Chinadrugtrials.org.cn. number: CTR20232098.
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