Major Depressive DisorderPhase 1NCT06964711
GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects
A Phase 1 study testing GW117 ODT in people with Major Depressive Disorder, run by Beijing Greatway Pharmaceutical Technology Co.,Ltd. at 1 site in China.
Trial summary
To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- GW117 ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2021to 24 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers
Read the detailed description
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in Chinese healthy volunteers.
- Conditions
- Major Depressive Disorder
- Being tested
- GW117 ODT, Placebo
- Keywords
- MDD, GW117, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW117 ODTDrug
Also called GW117 Orally Disintegrating Tablets
Sublingual route ， 0.5mg/1mg/2mg/4mg，QD
PlaceboDrug
GW117 Placebo matching for Sublingual route ，QD
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: GW117 ODT |
| Placebo | Placebo comparator | Take the tablet sublingually, Once daily SAD: Take once only MAD: Take for 7 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline up to Day 9
Secondary outcomes (4)
Pharmacokinetics -maximum plasma concentration (Cmax)
Determination of maximum plasma concentration (Cmax)
Measured: baseline up to Day 8
Pharmacokinetics - time to maximum concentration (Tmax)
Determination of time to maximum concentration
Measured: baseline up to Day 8
Pharmacokinetics - plasma exposure (AUC0-t, AUC0-inf)
Determination of plasma exposure (AUC0-t, AUC0-inf)
Measured: baseline up to Day 8
Pharmacokinetics - terminal elimination half life (t1/2)
Determination of terminal half life
Measured: baseline up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start12 Jul 2021
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Greatway Pharmaceutical Technology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964711
- Sponsor's protocol ID
- GW117-C102
- Other IDs
- CTR20221750
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06964711
- Acronym / sponsor ID
- GW117-C102
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, GW117, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Beijing Greatway Pharmaceutical Technology Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GW117 ODT (Orally disintegrating tablet) | Experimental | Drug: GW117 ODTTake the tablet sublingually, Once daily SAD: Take once only，0.5mg，1mg，2mg，4mg MAD: Take for 7 consecutive days，1mg，2mg |
| Placebo | Placebo comparator | Drug: PlaceboTake the tablet sublingually, Once daily SAD: Take once only MAD: Take for 7 consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW117 ODTAlso: GW117 Orally Disintegrating TabletsSublingual route ， 0.5mg/1mg/2mg/4mg，QD | Drug | GW117 ODT (Orally disintegrating tablet) |
| PlaceboGW117 Placebo matching for Sublingual route ，QD | Drug | Placebo |
Primary outcome
Percentage of participants with at least one safety event
Time frame: baseline up to Day 9
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.
4 secondary outcomes
Pharmacokinetics -maximum plasma concentration (Cmax)
Time frame: baseline up to Day 8
Pharmacokinetics - time to maximum concentration (Tmax)
Time frame: baseline up to Day 8
Pharmacokinetics - plasma exposure (AUC0-t, AUC0-inf)
Time frame: baseline up to Day 8
Pharmacokinetics - terminal elimination half life (t1/2)
Time frame: baseline up to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW117 ODT in people with Major Depressive Disorder, run by Beijing Greatway Pharmaceutical Technology Co.,Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with at least one safety event (time frame: baseline up to Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.