UnknownPhase 1

The MAD Study of SSGJ-613 in Healthy Subjects

China36 participantsStarted 2023-08-10

Plain-language summary

To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
✓. The body mass index (BMI) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
✓. Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent

✕. Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
✕. Subjects who have or are currently suffering from any serious clinical diseases before screening,
✕. Abnormal vital signs or abnormal ECGor physical examination are clinically significant
✕. Clinical laboratory examinations found to be abnormal and have clinical significance
✕. Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
✕. Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
✕. Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening
✕. Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration

Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.

Timeframe: Up to Day 174

NCT IDNCT05966701

SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-10

Qinghong Zhou, BS

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
✓. The body mass index (BMI) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
✓. Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent

✕. Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
✕. Subjects who have or are currently suffering from any serious clinical diseases before screening,
✕. Abnormal vital signs or abnormal ECGor physical examination are clinically significant
✕. Clinical laboratory examinations found to be abnormal and have clinical significance
✕. Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
✕. Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
✕. Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening
✕. Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration