Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of HEC116094(Part A, Cohort 1) | Experimental | Healthy subjects receive sinele dose of HEC116094 |
|
| Single dose of HEC116094(Part A, Cohort 2) | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
|
| Single dose of HEC116094(Part A, Cohort 3) | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
|
| 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. |
|
| Single dose of HEC116094(Part A, Cohort 5) | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
|
| Single dose of HEC116094(Part A, Cohort 6) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC116094 | Drug | Part B:Mulltiple doses up to 5 days; Part C:Each cycle was administered for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Plasma Concentration(Cmax)of HEC116094 | up to 72 hours |
| AUC | Area Under the Curve(AUC) of HEC116094 | up to 72 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shanghai xuhui district central hospital | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Healthy subjects receive sinele dose of HEC116094 or matching placebo |
|
| Single dose of HEC116094(Part A, Cohort 7) | Experimental | Healthy subjects receive sinele dose of HEC116094 or matching placebo |
|
| Mulltiple doses HEC116094( Part B, Cohort 1) | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
|
| Mulltiple doses HEC116094( Part B, Cohort 2) | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
|
| Mulltiple doses HEC116094( Part B, Cohort 3) | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
|
| Mulltiple doses HEC116094( Part B, Cohort 4) | Experimental | Healthy subjects receive multiple doses of HEC116094 or matching placebo |
|
| 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 |
|
|
| Tmax | Maximum Peak Time(Tmax) of HEC116094 | up to 72 hours |
| T1/2 | Maximum Peak Time(Tmax) of HEC116094 | up to 72 hours |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided