Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects

NCT04546984 | Completed Phase 1

• 1 other identifier: HEC96719-P-02/CRC-C2028
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719 in Healthy Subjects

Conditions

Nonalcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of HEC96719 by Assessment of the Number of Adverse Events

  To investigate the safety and tolerability of HEC96719 by assessment of AEs (non-serious and serious) following administration of oral solution in MAD

  up to 17 days

Secondary Outcomes (4)

• Cmax

  up to 96 hours

• AUC

  up to 96 hours

• Tmax

  up to 96 hours

• T1/2

  up to 96 hours

Study Arms (6)

Single dose of HEC96719 （Part 1，Fed/Fasting）

EXPERIMENTAL

Following an overnight fast of at least 10 hours, a single dose of HEC96719 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.

Drug: HEC96719

Mulltiple doses HEC96719（ Part 2, Cohort 1）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Drug: HEC96719

Mulltiple doses HEC96719（ Part 2, Cohort 2）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Drug: HEC96719

Mulltiple doses HEC96719（ Part 2, Cohort 3）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Drug: HEC96719

Mulltiple doses HEC96719（ Part 2, Cohort 4）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Drug: HEC96719

Mulltiple doses HEC96719（ Part 2, Cohort 5）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC96719 or matching placebo

Drug: HEC96719

Interventions

HEC96719 DRUG

Part 2：Mulltiple doses up to 10 days

Mulltiple doses HEC96719（ Part 2, Cohort 1）; Mulltiple doses HEC96719（ Part 2, Cohort 2）; Mulltiple doses HEC96719（ Part 2, Cohort 3）; Mulltiple doses HEC96719（ Part 2, Cohort 4）; Mulltiple doses HEC96719（ Part 2, Cohort 5）; Single dose of HEC96719 （Part 1，Fed/Fasting）

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study.
• Female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication.
• When signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited.
• Male body weight ≥50kg, female body weight ≥45kg, and body mass index (BMI) in the range of 18-28 kg/m2 (including the critical value).
• No clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest X-ray (posterior and anterior) results.

You may not qualify if:

• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
• Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations.
• Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
• Positive results from urine drug screen test.
• Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
• Subjects who plan to receive or have had organ transplants.
• Subjects considered by the investigator to have other factors unsuitable for participation in this study.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The Shanghai xuhui district central hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 14, 2020
• Study Start: September 14, 2020
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)