Non-alcoholic Steatohepatitis
Conditions
Brief summary
A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
Detailed description
This is the first time HEC88473 will be administered to humans. The aim of this study is to obtain safety, tolerability, PK, PD, and immunogenicity data of HEC88473 SC administration as single and multiple ascending doses in healthy subjects.
Interventions
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen
DRUGPlacebo
Placebo will be administered by subcutaneous injection in the abdomen
Sponsors
Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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
1. Males or females, of any race, between 18 and 60 years of age, inclusive, at screening. 2. Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening. 3. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee). 4. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). 3. History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing. 4. Alcohol consumption of \> 21 units per week for males and \> 14 units per week for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine. 5. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in. 6. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study. 7. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing. 8. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473 | Baseline to day 15 | — |
| Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473 | Baseline to day 43 | — |
| Cmax | Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours | Maximum observed plasma concentration of HEC88473 |
| AUC | Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours | Area under the plasma concentration-time curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OGTT | Predose and postdose 2, 4 hours | Oral glucose tolerance test |
| Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing | Baseline to day 43 | — |
Countries
Australia
Outcome results
None listed