GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects

NCT ID: NCT06964711

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-12
• Study Completion Date: 2023-03-24

Brief Summary

To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers

Detailed Description

Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in Chinese healthy volunteers.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GW117 ODT (Orally disintegrating tablet)

Take the tablet sublingually, Once daily SAD: Take once only，0.5mg，1mg，2mg，4mg MAD: Take for 7 consecutive days，1mg，2mg

Group Type: EXPERIMENTAL

GW117 ODT

Intervention Type: DRUG

Sublingual route ， 0.5mg/1mg/2mg/4mg，QD

Placebo

Take the tablet sublingually, Once daily SAD: Take once only MAD: Take for 7 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

GW117 Placebo matching for Sublingual route ，QD

Interventions

GW117 ODT

Sublingual route ， 0.5mg/1mg/2mg/4mg，QD

Intervention Type: DRUG

Placebo

GW117 Placebo matching for Sublingual route ，QD

Intervention Type: DRUG

Other Intervention Names

GW117 Orally Disintegrating Tablets

Eligibility Criteria

Inclusion Criteria

• Body weight should be at least 50.0kg for males and 45.0kg for females, with body mass index (weight/height 2) in the range of 19-26 kg/m2
• The results of physical examination were normal or abnormal without clinical significance;
• The results of vital signs were normal or abnormal without clinical significance
• The results of laboratory tests (blood routine, urine routine, liver function, renal function, blood glucose, electrolytes, coagulation function) were normal or abnormal without clinical significance
• negative results of pregnancy examination
• normal serological test results (five hepatitis B tests, hepatitis C antibodies, syphilis sero-specific antibodies, HIV antibodies)
• Normal or approximately normal or abnormal results of 12-lead electrocardiogram were not clinically significant
• Normal or abnormal chest X-ray findings had no clinical significance
• The normal or abnormal results of abdominal ultrasound had no clinical significance;
• Alcohol breath test results were negative
• Urine nicotine test results were negative
• Urine drug screening (morphine, methamphetamines, ketamine, dimethylenedioxyamphetamine, and tetrahydrocannabinol acid) was negative

Exclusion Criteria

• Allergic constitution or a history of drug or food allergy
• any medical history that may affect the safety of the trial or the in vivo course of the drug
• any history of surgery or trauma that may affect the safety of the trial or the course of the drug in vivo
• currently suffering from any unstable or recurrent disease or disease affecting the course of the drug in vivo
• a history of drug abuse/dependence in the past 2 years
• any medications used within 14 days before the test
• smoking within 2 weeks before medication or during the study period;
• alcohol abuse [drinking more than 14 units of alcohol per week in the 3 months before screening (1 unit of alcohol ≈360mL of 5% beer or 45mL of 40% spirits or 150mL of 12% wine)], or drinking alcohol within 1 week before medication, or unable to abstain from alcohol during the study
• participated in other drug clinical trials within 90 days before the trial
• blood loss or donation of 400mL or more within 90 days before the test;
• a history of fainting or bleeding
• lactating women
• plan to donate sperm or egg, plan to have children, or be unwilling or unable to take effective contraceptive measures within 30 days before the trial to 6 months after the end of the trial
• abnormal neurological or mental status or language disorder
• patients with abnormal saliva secretion, severe oral ulcer or other oral mucosal diseases;
• The investigators considered that they were not suitable to participate in the trial due to other circumstances

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Greatway Pharmaceutical Technology Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CTR20221750

Identifier Type: OTHER

Identifier Source: secondary_id

GW117-C102

Identifier Type: -

Identifier Source: org_study_id