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
Not provided
The purpose of this study is to evaluate the safety and tolerability of escalating single oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of escalating single oral doses of LY03005.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY03005 - 20 | Experimental | LY03005 Dose Strength 20mg |
|
| LY03005 - 40 | Experimental | LY03005 Dose Strength 40mg |
|
| LY03005- 80 | Experimental | LY03005 Dose Strength 80mg |
|
| LY03005 - 120 | Experimental | LY03005 Dose Strength 120mg |
|
| LY03005 - 160 | Experimental | LY03005 Dose Strength 160 mg |
|
| LY03005 - 200 | Experimental | LY03005 Dose Strength 200mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03005 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 11 Days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of: Cmax, | 4 days |
Not provided
Inclusion Criteria:
Are capable of giving informed consent and complying with study procedures;
Are between the ages of 18 and 45 years, inclusive;
Female subjects have a negative pregnancy test result prior to enrollment, and meet the following criteria defined as:
If child-bearing potential, agree to avoid pregnancy during the study and one month after the end of the study by using at least one effective contraceptive method(s), such as an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives used for at least one month prior to screening, injectable progesterone, or progesterone sub-dermal implants.
Surgically sterile for at least 3 months prior to screening by one of the following means:
Postmenopausal, defined as one of the following:
Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
Body mass index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 kg;
Willing and able to adhere to study restrictions and to be confined at the clinical research center.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simon Li | Luye Pharma Group Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace | Cincinnati | Ohio | 45227 | United States |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D062407 | Meals |
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LY03005 - 120 - Fed | Experimental | LY03005 120mg under Fed Conditions |
|
| Pristiq | Active Comparator | Pristiq - 50mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Placebo | Drug |
|
| Meal | Other |
|
| Pristiq | Drug |
|
| D003511 |
| Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |