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Major Depressive DisorderPhase 1NCT05195203

A Study of HS-10353 in Chinese Participants.

A Phase 1 study testing HS-10353 in people with Major Depressive Disorder, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 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?
HS-10353
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteChina
Study dates
27 Jan 2021to 31 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

SAD Inclusion Criteria

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

SAD Exclusion Criteria

  1. Pregnant and breastfeeding female.
  2. 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.
  3. The results of vital signs, physical examination, laboratory examination and 12-lead ECG during screening were abnormal with clinical significance.
  4. Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIVAb) or syphilis antibody is positive
  5. Volunteers had a history of drug dependence or abuse.
  6. 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.
  7. 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.
  8. Participate in clinical trials of any drug or medical device within 3 months prior to screening.
  9. Any medication taken within 2 weeks of administration, including prescription, over-the-counter, and herbal medicines.
  10. Diet or dietary treatment or significant change in dietary habits within 30 days prior to administration for whatever reason.
  11. Volunteers who have difficulty swallowing solid tablets or capsule.
  12. Volunteers with difficulty in blood collection, unable to tolerate multiple venous blood collection and any blood collection contraindications.

MAD Inclusion Criteria

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

MAD Exclusion criteria:

  1. Subject has a history of suicide attempt.
  2. 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.
  3. 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).
  4. Subject has detectable hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody at screening.
  5. Subject has active psychosis per Investigator assessment.
  6. Subject has a medical history of seizures.
  7. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  8. Subject has had exposure to another investigational medication or device within 30 days prior to screening.
  9. 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.
  10. 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital

    Chengdu, Sichuan

Other trials in China

About this study

Official title: A Phase I Randomized, Double-blinded, Placebo-controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of HS-10353 in Chinese Adult Subjects

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.

Being tested
HS-10353, Placebo
Keywords
Phase I, major depressive disorder, healthy subject, SAD, MAD
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10353Drug

    Also called HS-10353 capsules

    Single or multiple dose(s) of HS-10353

  • PlaceboDrug

    Also called HS-10353 placebo

    Single or multiple dose(s) of placebo

Study groups in NCT05195203
Study groupRoleWhat they receive
HS-10353ExperimentalCapsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days
Receives: Drug: HS-10353
PlaceboPlacebo comparatorCapsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endpoints of the trial：AE，SAE

    The incidence, severity, and association of AE, SAE and AE leading to withdrawal from the trial

    Measured: Baseline to end of follow-up (a maximum of 20 days)

Secondary outcomes (16)

  1. SAD pharmacokinetic endpoints：Cmax

    The maximum plasma concentration (Cmax)

    Measured: Day1-Day6

  2. SAD pharmacokinetic endpoints：Tmax

    Time to Cmax (Tmax)

    Measured: Day1-Day6

  3. 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)

    Measured: Day1-Day6

  4. SAD pharmacokinetic endpoints：AUC0-∞

    The area under the plasma concentration-time curve from time zero to infinite time (AUC0-∞)

    Measured: Day1-Day6

  5. SAD pharmacokinetic endpoints：λz

    Terminal rate constant (λz)

    Measured: Day1-Day6

  6. SAD pharmacokinetic endpoints：t½

    Half-life (t½)

    Measured: Day1-Day6

  7. SAD pharmacokinetic endpoints：CL/F

    Apparent clearance following oral administration (CL/F)

    Measured: Day1-Day6

  8. SAD pharmacokinetic endpoints：Vz/F

    Apparent volume of distribution following oral administration (Vz/F)

    Measured: Day1-Day6

  9. SAD pharmacokinetic endpoints：MRT

    Mean residence time (MRT)

    Measured: Day1-Day6

  10. MAD pharmacokinetic endpoints：Css,max

    The maximum steady state drug concentration in plasma during dosing interval (Css,max)

    Measured: Day1-Day12

  11. MAD pharmacokinetic endpoints：Css,av

    Average steady state drug concentration in plasma during dosing interval (Css,av)

    Measured: Day1-Day12

  12. MAD pharmacokinetic endpoints：Tss,max

    Time to Css, max (Tss,max)

    Measured: Day1-Day12

  13. 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)

    Measured: Day1-Day12

  14. MAD pharmacokinetic endpoints：DF

    Coefficient of fluctuation（DF）

    Measured: Day1-Day12

  15. MAD pharmacokinetic endpoints：Rac

    Accumulation ratio (Rac)

    Measured: Day1-Day12

  16. MAD pharmacokinetic endpoints：Css,min

    The minimum steady state drug concentration in plasma during dosing interval (Css,min)

    Measured: Day1-Day12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study start27 Jan 2021
  3. Primary completion11 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195203
Sponsor's protocol ID
HS-10353-101
Status last verified
Aug 2023
First submitted
12 Aug 2021
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

  • Wang Z, Li M, Xu X, Zhang R, Lin H, Yang F, Qi J, Zhang H, Tao Y, Shen Q. Phase 1 randomized trial of HS-10353, a novel GABA(A) positive allosteric modulator for treatment of major depressive disorder. BMC Med. 2026 May 21;24(1):399. doi: 10.1186/s12916-026-04926-5.

    PubMed 42169103

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10353 in people with Major Depressive Disorder, run by Jiangsu Hansoh Pharmaceutical 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?

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 3 Aug 2023. 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?

Endpoints of the trial：AE，SAE (time frame: Baseline to end of follow-up (a maximum of 20 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195203, which also lists 11 linked publications.

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 3 Aug 2023.

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