Clinical trial NCT04829123: The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Official title: A Phase 1, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
timeFrame: Baseline to day 15
measure: Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
timeFrame: Baseline to day 43
measure: Cmax
timeFrame: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
measure: AUC
timeFrame: Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Secondary outcomes:
measure: OGTT
timeFrame: Predose and postdose 2, 4 hours
measure: Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
timeFrame: Baseline to day 43
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Scientia Clinical Research
Study officials:
affiliation: Scientia Clinical Research
name: Charlotte Lemech, Doctor
role: PRINCIPAL_INVESTIGATOR
References: