A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults with Chronic Hepatitis B

Conditions

Chronic Hepatitis B

Brief summary

Incidence and severity of TEAEs from baseline to Month 6

Detailed description

Incidence and severity of TEAEs after Month 6 until end of study, CRMA-1001 in plasma PK parameters, including but not limited to: Cmax, Tmax, AUC, terminal clearance rate, volume of distribution, Incidence and characterization of ADAs by Month 6, Change in HBsAg; Change in anti-HBs antibody titer; Change in HBV DNA; Change in HBeAg in HBeAg-positive participants; Change in anti-HBe antibody titer in HBeAg positive participants. (All biomarkers will be evaluated as change from baseline to Month 6 and change from baseline to end of study), Proportion of participants able to discontinue NUC therapy by end of study, Incidence of functional cure (HBsAg loss [less than 0.05 IU/mL] and HBV DNA below the LLOQ ≥ 6 months after CRMA-1001 treatment and discontinuation of NUC therapy) by end of study

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Interventions

DRUGCRMA-1001

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Incidence and severity of TEAEs from baseline to Month 6	—

Secondary

Measure	Time frame
Incidence and severity of TEAEs after Month 6 until end of study, CRMA-1001 in plasma PK parameters, including but not limited to: Cmax, Tmax, AUC, terminal clearance rate, volume of distribution, Incidence and characterization of ADAs by Month 6, Change in HBsAg; Change in anti-HBs antibody titer; Change in HBV DNA; Change in HBeAg in HBeAg-positive participants; Change in anti-HBe antibody titer in HBeAg positive participants. (All biomarkers will be evaluated as change from baseline to Month 6 and change from baseline to end of study), Proportion of participants able to discontinue NUC therapy by end of study, Incidence of functional cure (HBsAg loss [less than 0.05 IU/mL] and HBV DNA below the LLOQ ≥ 6 months after CRMA-1001 treatment and discontinuation of NUC therapy) by end of study	—

Measure

Time frame

Incidence and severity of TEAEs after Month 6 until end of study, CRMA-1001 in plasma PK parameters, including but not limited to: Cmax, Tmax, AUC, terminal clearance rate, volume of distribution, Incidence and characterization of ADAs by Month 6, Change in HBsAg; Change in anti-HBs antibody titer; Change in HBV DNA; Change in HBeAg in HBeAg-positive participants; Change in anti-HBe antibody titer in HBeAg positive participants. (All biomarkers will be evaluated as change from baseline to Month 6 and change from baseline to end of study), Proportion of participants able to discontinue NUC therapy by end of study, Incidence of functional cure (HBsAg loss [less than 0.05 IU/mL] and HBV DNA below the LLOQ ≥ 6 months after CRMA-1001 treatment and discontinuation of NUC therapy) by end of study

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Outcome results

None listed