InfluenzaPhase 1NCT04982913
Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects
A Phase 1 study testing HEC116094 in people with Influenza, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- HEC116094
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2021to 2 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The Shanghai xuhui district central hospital
Shanghai, Shanghai Municipality
About this study
Official title: 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
- Conditions
- Influenza
- Being tested
- HEC116094
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC116094Drug
Also called Oseltamivir
Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Single dose of HEC116094（Part A, Cohort 1） | Experimental | Healthy subjects receive sinele dose of HEC116094 Receives: Drug: HEC116094 |
| Single dose of HEC116094（Part A, Cohort 2） | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Single dose of HEC116094（Part A, Cohort 3） | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo Receives: 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. Receives: Drug: HEC116094 |
| Single dose of HEC116094（Part A, Cohort 5） | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Single dose of HEC116094（Part A, Cohort 6） | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Single dose of HEC116094（Part A, Cohort 7） | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Mulltiple doses HEC116094（ Part B, Cohort 1） | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Mulltiple doses HEC116094（ Part B, Cohort 2） | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Mulltiple doses HEC116094（ Part B, Cohort 3） | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo Receives: Drug: HEC116094 |
| Mulltiple doses HEC116094（ Part B, Cohort 4） | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo Receives: 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 Receives: Drug: HEC116094 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of HEC116094 by Assessment of the Number of Adverse
To investigate the safety and tolerability of HEC116094 by assessment of AEs
Measured: up to 7 days at Part A and 11 days at Part B and 26 days at Part C
Secondary outcomes (4)
Cmax
Maximum Plasma Concentration(Cmax)of HEC116094
Measured: up to 72 hours
AUC
Area Under the Curve(AUC) of HEC116094
Measured: up to 72 hours
Tmax
Maximum Peak Time(Tmax) of HEC116094
Measured: up to 72 hours
T1/2
Maximum Peak Time(Tmax) of HEC116094
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start24 Aug 2021
- Primary completion2 Oct 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982913
- Sponsor's protocol ID
- HEC116094-P-01/CRC-C2104
- Status last verified
- Apr 2023
- First submitted
- 23 Jul 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04982913
- Acronym / sponsor ID
- HEC116094-P-01/CRC-C2104
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 2 Oct 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Single dose of HEC116094（Part A, Cohort 1） | Experimental | Drug: HEC116094Healthy subjects receive sinele dose of HEC116094 |
| Single dose of HEC116094（Part A, Cohort 2） | Experimental | Drug: HEC116094Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 3） | Experimental | Drug: HEC116094Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 4，Fed/Fasting） | Experimental | Drug: HEC116094Following 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. |
| Single dose of HEC116094（Part A, Cohort 5） | Experimental | Drug: HEC116094Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 6） | Experimental | Drug: HEC116094Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Single dose of HEC116094（Part A, Cohort 7） | Experimental | Drug: HEC116094Healthy subjects receive sinele dose of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 1） | Experimental | Drug: HEC116094Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 2） | Experimental | Drug: HEC116094Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 3） | Experimental | Drug: HEC116094Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| Mulltiple doses HEC116094（ Part B, Cohort 4） | Experimental | Drug: HEC116094Healthy subjects receive multiple doses of HEC116094 or matching placebo |
| The interaction with Oseltamivir of HEC116094（ Part C） | Experimental | Drug: HEC116094Healthy 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEC116094Also: OseltamivirPart B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days | Drug | 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） |
Primary outcome
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
4 secondary outcomes
Cmax
Time frame: up to 72 hours
AUC
Time frame: up to 72 hours
Tmax
Time frame: up to 72 hours
T1/2
Time frame: up to 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
RecruitingPhase 4
Impact of Egg-Based and Cell-Based Vaccine Platforms on Immune Responses to Repeated Influenza Vaccination
Immunology
RecruitingEarly Phase 1
Intradermal Influenza Vaccination
Vaccine Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HEC116094 in people with Influenza, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.