This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial consisting of two parts. Part 1 includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts conducted in healthy participants. Part 2 is a multiple ascending dose (MAD) trial enrolling HBeAg-negative chronic hepatitis B (CHB) participants with suppressed HBV DNA under stable nucleos(t)ide analog (NA) therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Part 1 SAD (Single Ascending Dose): Single-dose subcutaneous injection per assigned dose group. Part 1 MAD (Multiple Ascending Dose) and Part 2: Subcutaneous injection per assigned dose group; treatment duration shall follow the study protocol.
Part 1 SAD (Single Ascending Dose): Single-dose subcutaneous injection administered per assigned dose group. Part 1 MAD (Multiple Ascending Dose) and Part 2: Subcutaneous injection administered per assigned dose group; the treatment duration shall comply with the study protocol.
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGSafety: number of participants with adverse event (AE), serious adverse events (SAE) and clinically significant examination results.
Assessments include vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs).
Time frame: throughout the full study period,an average of 4 months
Plasma drug concentrations in healthy participants and participants withCHB
Time frame: throughout the full study period,an average of 4 months
Area Under the Concentration-Time Curve from time zero to the last measurable concentration(AUC₀-ₜ)
Time frame: throughout the full study period,an average of 4 months
Area Under the Concentration-Time Curve from time zero to infinity(AUC₀-∞)
Time frame: throughout the full study period,an average of 4 months
Apparent Volume of Distribution(Vd/F)
Time frame: throughout the full study period,an average of 4 months
First-order Elimination Rate Constant(Kel)
Time frame: throughout the full study period,an average of 4 months
Elimination Half-life(t₁/₂)
Time frame: throughout the full study period,an average of 4 months
Mean Residence Time(MRT)
Time frame: throughout the full study period,an average of 4 months
Apparent Clearance(CL/F)
Time frame: throughout the full study period,an average of 4 months
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Minimum Plasma Concentration at Steady State(Cₘᵢₙ,ₛₛ)
Time frame: throughout the full study period,an average of 4 months
Maximum Plasma Concentration at Steady State(Cₘₐₓ,ₛₛ)
Time frame: throughout the full study period,an average of 4 months
Average Plasma Concentration at Steady State(Cₐᵥ,ₛₛ)
Time frame: throughout the full study period,an average of 4 months
Area Under the Concentration-Time Curve over one dosing interval at steady state(AUC₀-τ)
Time frame: throughout the full study period,an average of 4 months
Degree of Fluctuation (DF)
Time frame: throughout the full study period,an average of 4 months
Accumulation Factor (Rac)
Time frame: throughout the full study period,an average of 4 months
Urinary Concentration
Time frame: throughout the full study period,an average of 4 months
Cumulative Amount Excreted in Urine
Time frame: throughout the full study period,an average of 4 months
Cumulative Percentage of Dose Excreted in Urine
Time frame: throughout the full study period,an average of 4 months
Renal Clearance(CL)
Time frame: throughout the full study period,an average of 4 months
HBsAg and HBsAb levels and changes from baseline among participants with CHB
Time frame: throughout the full study period,an average of 4 months
HBsAg seroclearance rate among participants with CHB
Time frame: throughout the full study period,an average of 4 months
HBsAg seroconversion rate among participants with CHB
Time frame: throughout the full study period,an average of 4 months
Placebo-corrected baseline-adjusted ΔQTc (ΔΔQTc) among healthy participants
Time frame: throughout the full study period,an average of 4 months
Anti-drug antibody (ADA) positive rate among healthy participants and participants with CHB
Time frame: throughout the full study period,an average of 4 months
Antibody titers among healthy participants and participants with CHB
Time frame: throughout the full study period,an average of 4 months