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

April 10, 2023 updated by: Sunshine Lake Pharma Co., Ltd.

A Single-Center, Randomized, Double-Blind, Single and Multiple Doses, Placebo-Controlled Study,To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Food Effects of HEC116094HCl•3H2O and the Interaction With Oseltamivir Phosphate Capsules in Chinese Healthy Subjects

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • The Shanghai xuhui district central hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single dose of HEC116094（Part A, Cohort 1）
Healthy subjects receive sinele dose of HEC116094
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Single dose of HEC116094（Part A, Cohort 2）
Healthy subjects receive sinele dose of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Single dose of HEC116094（Part A, Cohort 3）
Healthy subjects receive sinele dose of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Single dose of HEC116094（Part A, Cohort 4，Fed/Fasting）
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
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Single dose of HEC116094（Part A, Cohort 5）
Healthy subjects receive sinele dose of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Single dose of HEC116094（Part A, Cohort 6）
Healthy subjects receive sinele dose of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Single dose of HEC116094（Part A, Cohort 7）
Healthy subjects receive sinele dose of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Mulltiple doses HEC116094（ Part B, Cohort 1）
Healthy subjects receive multiple doses of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Mulltiple doses HEC116094（ Part B, Cohort 2）
Healthy subjects receive multiple doses of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Mulltiple doses HEC116094（ Part B, Cohort 3）
Healthy subjects receive multiple doses of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: Mulltiple doses HEC116094（ Part B, Cohort 4）
Healthy subjects receive multiple doses of HEC116094 or matching placebo
Drug: HEC116094
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir
Experimental: The interaction with Oseltamivir of HEC116094（ Part C）
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
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
Other Names:
  • Oseltamivir

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of HEC116094 by Assessment of the Number of Adverse
Time Frame: up to 7 days at Part A and 11 days at Part B and 26 days at Part C
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 72 hours
Maximum Plasma Concentration(Cmax)of HEC116094
up to 72 hours
AUC
Time Frame: up to 72 hours
Area Under the Curve(AUC) of HEC116094
up to 72 hours
Tmax
Time Frame: up to 72 hours
Maximum Peak Time(Tmax) of HEC116094
up to 72 hours
T1/2
Time Frame: up to 72 hours
Maximum Peak Time(Tmax) of HEC116094
up to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Lake Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HEC116094-P-01/CRC-C2104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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