The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects

Non-alcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829123
• Other study ID #: HEC88473-DM-102
• Status: Completed
• Phase: Phase 1
• Start date: May 14, 2021
• Est. completion date: March 2, 2022

Study information

• Verified date: February 2023
• Source: Dongguan HEC Biopharmaceutical R&D Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• HEC88473 injection
HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen
• Placebo
Placebo will be administered by subcutaneous injection in the abdomen

Locations

Country	Name	City	State
Australia	Scientia Clinical Research	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Dongguan HEC Biopharmaceutical R&D Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473		Baseline to day 15
Primary	Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473		Baseline to day 43
Primary	Cmax	Maximum observed plasma concentration of HEC88473	Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Primary	AUC	Area under the plasma concentration-time curve (AUC)	Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours
Secondary	OGTT	Oral glucose tolerance test	Predose and postdose 2, 4 hours
Secondary	Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing		Baseline to day 43