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GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT06964711•Beijing Greatway Pharmaceutical Technology Co.,Ltd.

View on ClinicalTrials.gov

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

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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
+2 more criteria

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;
+6 more criteria

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

July 12, 2021

Primary Completion Date

March 24, 2023

Completion Date

March 24, 2023

Last Updated

May 9, 2025

Enrollment

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

GW117 ODT

DRUG

Placebo

DRUG

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Major Depressive Disorder

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use