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

NCT06964711 | Completed Phase 1

• 2 other identifiers: GW117-C102CTR20221750
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder

Keywords

MDD; GW117; Depression

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with at least one safety event

  Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, electrocardiogram (ECG) evaluations, clinical laboratory assessments, and physical examination findings. Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) will be captured.

  baseline up to Day 9

Secondary Outcomes (4)

• Pharmacokinetics -maximum plasma concentration (Cmax)

  baseline up to Day 8

• Pharmacokinetics - time to maximum concentration (Tmax)

  baseline up to Day 8

• Pharmacokinetics - plasma exposure (AUC0-t, AUC0-inf)

  baseline up to Day 8

• Pharmacokinetics - terminal elimination half life (t1/2)

  baseline up to Day 8

Study Arms (2)

GW117 ODT (Orally disintegrating tablet)

EXPERIMENTAL

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

Drug: GW117 ODT

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

GW117 ODT DRUG

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

Also known as: GW117 Orally Disintegrating Tablets

GW117 ODT (Orally disintegrating tablet)

Placebo DRUG

GW117 Placebo matching for Sublingual route ，QD

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Greatway Pharmaceutical Technology Co.,Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 9, 2025
• Study Start: July 12, 2021
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)