CompletedPhase 1

A Study of HS-10353 in Chinese Participants.

China96 participantsStarted 2021-01-27

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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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.

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.

What they're measuring

Endpoints of the trial：AE，SAE

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

Trial details

NCT IDNCT05195203

SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-11

View on ClinicalTrials.gov More Major Depressive Disorder trials