Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects

NCT04982913 | Completed Phase 1

• 1 other identifier: HEC116094-P-01/CRC-C2104
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of HEC116094 by Assessment of the Number of Adverse

  To investigate the safety and tolerability of HEC116094 by assessment of AEs

  up to 7 days at Part A and 11 days at Part B and 26 days at Part C

Secondary Outcomes (4)

• Cmax

  up to 72 hours

• AUC

  up to 72 hours

• Tmax

  up to 72 hours

• T1/2

  up to 72 hours

Study Arms (12)

Single dose of HEC116094（Part A, Cohort 1）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC116094

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 2）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 3）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 4，Fed/Fasting）

EXPERIMENTAL

Following an overnight fast of at least 10 hours, a single dose of HEC116094 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 5）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 6）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 7）

EXPERIMENTAL

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 1）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 2）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 3）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 4）

EXPERIMENTAL

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Drug: HEC116094

The interaction with Oseltamivir of HEC116094（ Part C）

EXPERIMENTAL

Healthy subjects received HEC116094 in cycle 1, Oseltamivir in cycle 2, and a combination of HEC116094 and Oseltamivir in cycle 3.There are washout periods between the first cycle and the second cycle and between the second cycle and the third cycle

Drug: HEC116094

Interventions

HEC116094 DRUG

Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days

Also known as: Oseltamivir

Mulltiple doses HEC116094（ Part B, Cohort 1）; Mulltiple doses HEC116094（ Part B, Cohort 2）; Mulltiple doses HEC116094（ Part B, Cohort 3）; Mulltiple doses HEC116094（ Part B, Cohort 4）; Single dose of HEC116094（Part A, Cohort 1）; Single dose of HEC116094（Part A, Cohort 2）; Single dose of HEC116094（Part A, Cohort 3）; Single dose of HEC116094（Part A, Cohort 4，Fed/Fasting）; Single dose of HEC116094（Part A, Cohort 5）; Single dose of HEC116094（Part A, Cohort 6）; Single dose of HEC116094（Part A, Cohort 7）; The interaction with Oseltamivir of HEC116094（ Part C）

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

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

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: July 23, 2021
• First Posted: July 29, 2021
• Study Start: August 24, 2021
• Primary Completion: October 2, 2022
• Study Completion: October 2, 2022
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)