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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: HEC116094

Study type: Interventional

Funder types: Industry

Identifiers

NCT04982913

HEC116094-P-01/CRC-C2104

Details and patient eligibility

About

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

Enrollment: 118 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 12 patient groups

Single dose of HEC116094（Part A, Cohort 1）

Experimental group

Description:

Healthy subjects receive sinele dose of HEC116094

Treatment:

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 2）

Experimental group

Description:

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 3）

Experimental group

Description:

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

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

Experimental group

Description:

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.

Treatment:

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 5）

Experimental group

Description:

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 6）

Experimental group

Description:

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Single dose of HEC116094（Part A, Cohort 7）

Experimental group

Description:

Healthy subjects receive sinele dose of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 1）

Experimental group

Description:

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 2）

Experimental group

Description:

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 3）

Experimental group

Description:

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

Mulltiple doses HEC116094（ Part B, Cohort 4）

Experimental group

Description:

Healthy subjects receive multiple doses of HEC116094 or matching placebo

Treatment:

Drug: HEC116094

The interaction with Oseltamivir of HEC116094（ Part C）

Experimental group

Description:

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

Treatment:

Drug: HEC116094