CompletedNCT05195203Updated Aug 3, 2023

A Study of HS-10353 in Chinese Participants.

A Phase 1 interventional study of HS-10353 and Placebo in Major Depressive Disorder, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 6 months after the study started (first participant enrolled Jan 2021, registered Aug 2021).

Phase: Phase 1
Study type: Interventional
Enrollment: 96
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10353 separately in Chinese healthy and major depressive disorder subjects.

Read the detailed description

This is a phase I, randomized, double-blinded, placebo-controlled, both single ascending doses (SAD) study and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10353 tablet(s) separately in Chinese healthy and major depressive disorder (MDD) subjects.

Approximately six sequential dose cohorts will be evaluated in SAD study. Sentinel dosing will be employed for the first SAD cohort to protect the subjects' safety. Escalation to the next dose cohort will be undertaken only after safety and PK data are reviewed by the Safety Review Committee (SRC) and agreement reach that it is safe to increase the dose. Each SAD cohort is dosed at approximately weekly intervals to allow adequate time for collection and review of safety and PK data.

Approximately three sequential dose cohorts will be evaluated in MAD study. The total daily dose for each MAD cohort will be based on information obtained from the SAD study. Each subject will receive only one dose regimen in this study.

Safety data up to Day14 (±1) in SAD and up to Day20 (±1) in MAD will be reviewed prior to the next dose level. The number of Cohorts in SAD and MAD would be adjusted based on the assessment of SRC.

Conditions studied

Major Depressive Disorder

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Keywords

Phase I
major depressive disorder
healthy subject
SAD
MAD

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 96 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 131 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

SAD Inclusion Criteria

Healthy male or female subjects between 18 and 45 years old;
Body weight more than 50.0kg (male) or 45.0kg (female), body mass index (BMI) within the range of 19.0\~26.0kg/m2;
Volunteers agree to refrain from smoking, drinking alcohol. Avoid xanthine or caffeine (including chocolate, tea, coffee, cola, etc.) and avoid strenuous exercise;
The male volunteers agreed to refrain from donating sperm from the start of the drug until six months after they stopped the study;
The female volunteers agreed to avoid ovum donation from the start of the drug until six months after they stopped the study;
Pregnancy test results of female volunteers must be negative within 3 days of administration.

SAD Exclusion Criteria

Pregnant and breastfeeding female.
Volunteers with a history of cardiovascular, respiratory, liver, kidney, digestive tract, mental, neurological, hematological, metabolic and other systemic diseases, who are not suitable to participate in this study as assessed by the investigator.
The results of vital signs, physical examination, laboratory examination and 12-lead ECG during screening were abnormal with clinical significance.
Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIVAb) or syphilis antibody is positive
Volunteers had a history of drug dependence or abuse.
A heavy smoker or smokers who smoked 5 or more cigarettes per day for 3 months prior to screening or tested positive for nicotine during screening.
A history of alcohol abuse or a single consumption of more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, 150 mL of wine) in the nearly two weeks prior to screening or a positive breath test for alcohol at screening.
Participate in clinical trials of any drug or medical device within 3 months prior to screening.
Any medication taken within 2 weeks of administration, including prescription, over-the-counter, and herbal medicines.
Diet or dietary treatment or significant change in dietary habits within 30 days prior to administration for whatever reason.
Volunteers who have difficulty swallowing solid tablets or capsule.
Volunteers with difficulty in blood collection, unable to tolerate multiple venous blood collection and any blood collection contraindications.

MAD Inclusion Criteria

Subject has signed an ICF prior to any study-specific procedures being performed.
Subject is an ambulatory male or female between 18 and 65 years of age, inclusive.
Subject has a diagnosis of MDD that has been present for at least a 4-week period as diagnosed by DSM-5.
Subject has a HAM-D17 total score of ≥22 at screening and Day 1 (prior to dosing).
Subject is willing to discontinue other antidepressant or anti-anxiety medications （such as benzodiazepines） or antipsychotics during screening and treatment.

MAD Exclusion criteria:

Subject has a history of suicide attempt.
Subject has a recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, neurological, or eyes, ears, nose, and throat disorders, or any other acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
Subject has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time (ie, at least 4 weeks of treatment).
Subject has detectable hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody at screening.
Subject has active psychosis per Investigator assessment.
Subject has a medical history of seizures.
Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Subject has had exposure to another investigational medication or device within 30 days prior to screening.
Subject has had administration of psychotropics that have been initiated within 14 days prior to screening and/or are not being taken at a stable dose.
Use of any known strong inhibitors and/or inducers of cytochrome P450 (CYP)3A4 within the 14 days or five half-lives (whichever is longer) or consumed grapefruit juice, grapefruit, Seville oranges, or products containing these within 30 days prior to receiving the first dose of study drug.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Double (Participant, Investigator)
Enrollment: 96 participants (actual)

Study arms

Experimental
HS-10353
Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days
Drug: HS-10353
Placebo comparator
Placebo
Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days
Drug: Placebo

Interventions

DrugHS-10353
Single or multiple dose(s) of HS-10353
Also known as: HS-10353 capsules
DrugPlacebo
Single or multiple dose(s) of placebo
Also known as: HS-10353 placebo

What researchers measure

Primary outcomes

Endpoints of the trial：AE，SAE
The incidence, severity, and association of AE, SAE and AE leading to withdrawal from the trial
Time frame: Baseline to end of follow-up (a maximum of 20 days)

Secondary outcomes

SAD pharmacokinetic endpoints：Cmax
The maximum plasma concentration (Cmax)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：Tmax
Time to Cmax (Tmax)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：AUC0-t
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：AUC0-∞
The area under the plasma concentration-time curve from time zero to infinite time (AUC0-∞)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：λz
Terminal rate constant (λz)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：t½
Half-life (t½)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：CL/F
Apparent clearance following oral administration (CL/F)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：Vz/F
Apparent volume of distribution following oral administration (Vz/F)
Time frame: Day1-Day6
SAD pharmacokinetic endpoints：MRT
Mean residence time (MRT)
Time frame: Day1-Day6
MAD pharmacokinetic endpoints：Css,max
The maximum steady state drug concentration in plasma during dosing interval (Css,max)
Time frame: Day1-Day12
MAD pharmacokinetic endpoints：Css,av
Average steady state drug concentration in plasma during dosing interval (Css,av)
Time frame: Day1-Day12
MAD pharmacokinetic endpoints：Tss,max
Time to Css, max (Tss,max)
Time frame: Day1-Day12
MAD pharmacokinetic endpoints：AUCss, 0-t
The area under the plasma concentration-time curve from time zero to the time of the last measurable concentration over the dosing interval at steady state (AUCss, 0-t)
Time frame: Day1-Day12
MAD pharmacokinetic endpoints：DF
Coefficient of fluctuation（DF）
Time frame: Day1-Day12
MAD pharmacokinetic endpoints：Rac
Accumulation ratio (Rac)
Time frame: Day1-Day12
MAD pharmacokinetic endpoints：Css,min
The minimum steady state drug concentration in plasma during dosing interval (Css,min)
Time frame: Day1-Day12

Other outcomes

MAD pharmacodynamics endpoints：Ham-D17 response rate
Ham-D17 response rate (score decreased ≥50% from baseline) and (score ≤7)
Time frame: Day1-Day12

Study locations

1 site

West China Hospital
Chengdu, Sichuan, China

References and documents

Publications

Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29. PubMed 23993280 ↗
McIntyre RS, Suppes T, Tandon R, Ostacher M. Florida Best Practice Psychotherapeutic Medication Guidelines for Adults With Major Depressive Disorder. J Clin Psychiatry. 2017 Jun;78(6):703-713. doi: 10.4088/JCP.16cs10885. PubMed 28682531 ↗
Papakostas GI, Fava M. Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. Eur Neuropsychopharmacol. 2009 Jan;19(1):34-40. doi: 10.1016/j.euroneuro.2008.08.009. Epub 2008 Sep 26. PubMed 18823760 ↗
Luscher B, Shen Q, Sahir N. The GABAergic deficit hypothesis of major depressive disorder. Mol Psychiatry. 2011 Apr;16(4):383-406. doi: 10.1038/mp.2010.120. Epub 2010 Nov 16. PubMed 21079608 ↗
Mann JJ, Oquendo MA, Watson KT, Boldrini M, Malone KM, Ellis SP, Sullivan G, Cooper TB, Xie S, Currier D. Anxiety in major depression and cerebrospinal fluid free gamma-aminobutyric acid. Depress Anxiety. 2014 Oct;31(10):814-21. doi: 10.1002/da.22278. Epub 2014 May 27. PubMed 24865448 ↗
Schur RR, Draisma LW, Wijnen JP, Boks MP, Koevoets MG, Joels M, Klomp DW, Kahn RS, Vinkers CH. Brain GABA levels across psychiatric disorders: A systematic literature review and meta-analysis of (1) H-MRS studies. Hum Brain Mapp. 2016 Sep;37(9):3337-52. doi: 10.1002/hbm.23244. Epub 2016 May 4. PubMed 27145016 ↗
Zorumski CF, Paul SM, Izumi Y, Covey DF, Mennerick S. Neurosteroids, stress and depression: potential therapeutic opportunities. Neurosci Biobehav Rev. 2013 Jan;37(1):109-22. doi: 10.1016/j.neubiorev.2012.10.005. Epub 2012 Oct 17. PubMed 23085210 ↗
Uzunova V, Sheline Y, Davis JM, Rasmusson A, Uzunov DP, Costa E, Guidotti A. Increase in the cerebrospinal fluid content of neurosteroids in patients with unipolar major depression who are receiving fluoxetine or fluvoxamine. Proc Natl Acad Sci U S A. 1998 Mar 17;95(6):3239-44. doi: 10.1073/pnas.95.6.3239. PubMed 9501247 ↗
Fellmeth G, Fazel M, Plugge E. Migration and perinatal mental health in women from low- and middle-income countries: a systematic review and meta-analysis. BJOG. 2017 Apr;124(5):742-752. doi: 10.1111/1471-0528.14184. Epub 2016 Jun 20. PubMed 27320110 ↗
Osborne LM, Gispen F, Sanyal A, Yenokyan G, Meilman S, Payne JL. Lower allopregnanolone during pregnancy predicts postpartum depression: An exploratory study. Psychoneuroendocrinology. 2017 May;79:116-121. doi: 10.1016/j.psyneuen.2017.02.012. Epub 2017 Feb 16. PubMed 28278440 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05195203
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jan 18, 2022
Start date: Jan 27, 2021
Primary completion: Mar 11, 2023
Completion: Mar 31, 2023
Last update: Aug 3, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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