Chronic Hepatitis b
Conditions
Brief summary
This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics. In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).
Interventions
DRUGTQA3038 injection
TQA3038 is an injection.
DRUGTQA3038 injection matching placebo
Placebo injection contains no active substance.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female age 18～60 years. * Body mass index (BMI) 19 - 26 kg/m\^2.
Exclusion criteria
* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation； * History or evidence of drug or alcohol abuse； * History of intolerance to SC injection；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Up to 85 days. | Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Number of subjects with clinically significant abnormalities | Up to 85 days. | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time |
| Apparent Terminal Elimination Half-life (T1/2) | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma |
| Maximum Plasma Concentration (Cmax) | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | Maximum concentration of TQA3038 and its metabolite in plasma |
| Fraction eliminated in the urine | Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1. | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma |
| Apparent Plasma Clearance (CL/F) | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma |
| Time to Reach Maximum Plasma Concentration (Tmax) | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose | Time to reach Cmax of TQA3038 and its metabolite in plasma |
Countries
China
Contacts
Primary ContactDong Liu, Doctor
Backup ContactZheLong Liu, Doctor
Outcome results
None listed