Clinical trial NCT06964711: GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability and Pharmacokinetics of GW117 ODT in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: MDD
GW117
Depression
Lead sponsor: Beijing Greatway Pharmaceutical Technology Co.,Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of participants with at least one safety event
timeFrame: baseline up to Day 9
Secondary outcomes:
measure: Pharmacokinetics -maximum plasma concentration (Cmax)
timeFrame: baseline up to Day 8
measure: Pharmacokinetics - time to maximum concentration (Tmax)
timeFrame: baseline up to Day 8
measure: Pharmacokinetics - plasma exposure (AUC0-t, AUC0-inf)
timeFrame: baseline up to Day 8
measure: Pharmacokinetics - terminal elimination half life (t1/2)
timeFrame: baseline up to Day 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: