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

Dongguan HEC Biopharmaceutical

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: HEC88473 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04829123

HEC88473-DM-102

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 11 patient groups

Single dose of 0.5 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 0.5 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 1.7 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 1.7 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 5.1 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 5.1 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 10.2 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 10.2 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 17.0 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 17.0 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 25.5 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 25.5 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 34.0 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 34.0 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Single dose of 44.2 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a single dose of 44.2 mg HEC88473 (N=6) or placebo(N=2) after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Multiple doses of 1.7 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a weekly dose of 1.7 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Multiple doses of 5.1 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a weekly dose of 5.1 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection

Multiple doses of 10.2 mg HEC88473

Experimental group

Description:

Healthy subjects, receiving a weekly dose of 10.2 mg HEC88473 (N=10) or placebo (N=2) for 5 consecutive weeks after meal.

Treatment:

Drug: Placebo

Drug: HEC88473 injection