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

NCT04829123 | Completed Phase 1

• 1 other identifier: HEC88473-DM-102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Non-alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (4)

• 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

  Maximum observed plasma concentration of HEC88473

  Predose and postdose 4, 8, 10, 12, 14, 24, 48, 72, 96, 168, 216, and 336 hours

• 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 Outcomes (2)

• OGTT

  Predose and postdose 2, 4 hours

• Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing

  Baseline to day 43

Study Arms (11)

Single dose of 0.5 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 1.7 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 5.1 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 10.2 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 17.0 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 25.5 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 34.0 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Single dose of 44.2 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Multiple doses of 1.7 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Multiple doses of 5.1 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Multiple doses of 10.2 mg HEC88473

EXPERIMENTAL

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

Drug: HEC88473 injection; Drug: Placebo

Interventions

HEC88473 injection DRUG

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

Multiple doses of 1.7 mg HEC88473; Multiple doses of 10.2 mg HEC88473; Multiple doses of 5.1 mg HEC88473; Single dose of 0.5 mg HEC88473; Single dose of 1.7 mg HEC88473; Single dose of 10.2 mg HEC88473; Single dose of 17.0 mg HEC88473; Single dose of 25.5 mg HEC88473; Single dose of 34.0 mg HEC88473; Single dose of 44.2 mg HEC88473; Single dose of 5.1 mg HEC88473

Placebo DRUG

Placebo will be administered by subcutaneous injection in the abdomen

Multiple doses of 1.7 mg HEC88473; Multiple doses of 10.2 mg HEC88473; Multiple doses of 5.1 mg HEC88473; Single dose of 0.5 mg HEC88473; Single dose of 1.7 mg HEC88473; Single dose of 10.2 mg HEC88473; Single dose of 17.0 mg HEC88473; Single dose of 25.5 mg HEC88473; Single dose of 34.0 mg HEC88473; Single dose of 44.2 mg HEC88473; Single dose of 5.1 mg HEC88473

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, of any race, between 18 and 60 years of age, inclusive, at screening.
• Body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
• 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).
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

You may not qualify if:

• 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).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• History of alcoholism or drug/chemical abuse within 2 years prior to the first dosing.
• 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.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Dongguan HEC Biopharmaceutical R&D Co., Ltd.: lead

Study Sites (1)

Scientia Clinical Research

Sydney, Australia

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Charlotte Lemech, Doctor

  Scientia Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 2, 2021
• Study Start: May 14, 2021
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)