A Study of HS-10353 in Chinese Participants.

NCT05195203 | Completed Phase 1

• 1 other identifier: HS-10353-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Phase I; major depressive disorder; healthy subject; SAD; MAD

Outcome Measures

Primary Outcomes (1)

• Endpoints of the trial：AE，SAE

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

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

Secondary Outcomes (16)

• SAD pharmacokinetic endpoints：Cmax

  Day1-Day6

• SAD pharmacokinetic endpoints：Tmax

  Day1-Day6

• SAD pharmacokinetic endpoints：AUC0-t

  Day1-Day6

• SAD pharmacokinetic endpoints：AUC0-∞

  Day1-Day6

• SAD pharmacokinetic endpoints：λz

  Day1-Day6

Other Outcomes (1)

• MAD pharmacodynamics endpoints：Ham-D17 response rate

  Day1-Day12

Study Arms (2)

HS-10353

EXPERIMENTAL

Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days

Drug: HS-10353

Placebo

PLACEBO COMPARATOR

Capsules；Single dose: only one administration; Multiple doses: continuous administration for 7 days

Drug: Placebo

Interventions

HS-10353 DRUG

Single or multiple dose(s) of HS-10353

Also known as: HS-10353 capsules

HS-10353

Placebo DRUG

Single or multiple dose(s) of placebo

Also known as: HS-10353 placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

Location

Related Publications (10)

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  PMID: 23993280 BACKGROUND

• 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.

  PMID: 28682531 BACKGROUND

• 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.

  PMID: 18823760 BACKGROUND

• 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.

  PMID: 21079608 BACKGROUND

• 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.

  PMID: 24865448 BACKGROUND

• 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.

  PMID: 27145016 BACKGROUND

• 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.

  PMID: 23085210 BACKGROUND

• 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.

  PMID: 9501247 BACKGROUND

• 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.

  PMID: 27320110 BACKGROUND

• 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.

  PMID: 28278440 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: January 18, 2022
• Study Start: January 27, 2021
• Primary Completion: March 11, 2023
• Study Completion: March 31, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

CN (1)