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
| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. The secondary objectives include: Evaluating the pharmacokinetic characteristics of HY-2003 after a single administration in humans and obtaining preliminary pharmacokinetic parameters; Evaluating the efficacy of HY-2003 under different doses and dosing frequencies, compared with the positive control and placebo, in the treatment of subjects with moderate to severe submental fat accumulation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Subjects will be randomly assigned to three subgroups | Experimental |
| |
| Group B - Subjects will be randomly assigned to two subgroups | Experimental |
| |
| Group C - Subjects will be randomly assigned to two subgroups | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HY-2003 (10 mg/ml), BELKYRA and placebo | Drug | Participants received HY-2003 (10 mg/ml), or BELKYRA, or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of all adverse events; The occurrence of adverse events at the injection site; Laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms. | During the intervention | |
| Pain scores evaluated by the Visual Analogue Scale (VAS,0~10mm,the longer the length means a worse outcome) | During the intervention | |
| The scores of submental skin laxity evaluated by the Submental Skin Laxity Grade (SMSLG, 0~4 points, the higher score means a worse outcome) | Four weeks and twelve weeks after the last treatment. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun Wan | Contact | 028-86021875 | chun.wan3717@huiyupharma.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HY-2003 (5 mg/ml) and placebo | Drug | Participants received HY-2003 (5 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments. |
|
| HY-2003 (5 mg/ml) and placebo | Drug | Participants received HY-2003 (10 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments. It is possible to explore the maximum number of administrations exceeding six treatment sessions. |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
|
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |