Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT07776041

A Study of SYH2092 Injection in Healthy Participants

Conditions: Overweight or Obesity

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 46
Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

Location: Nucleus Network Pty Ltd. Melbourne Victoria

Summary

To evaluate the safety and tolerability of SYH2092 Injection in healthy participants

Eligibility Criteria

Inclusion Criteria: 1. Fully understand the content, process and possible adverse drug reactions (ADRs) of the study before the study, and voluntarily sign the ICF; 2. At Screening, aged 18 to 60 years (inclusive, based on the date of signing the ICF), including both males and females; 3. At Screening, body weight ≥ 50 kg with a body mass index (BMI) of 18 to 35 kg/m² 4. Body weight change ≤ 5% within 3 months prior to Screening (including the Screening Period) (based on participant self-report); 5. Participants (including their partners) have no birth plan from signing the ICF until 6 months after the last dose, and agree to use highly effective contraceptive measures as stipulated in the protocol. Exclusion Criteria: 1. Known or suspected allergy to amylin receptor agonists or any component of the investigational product; or those with an allergic constitution (allergy to multiple drugs and foods); 2. Clinically significant abnormal results in vital signs, physical examination, laboratory tests, or ECG, as judged by the Investigator, that render the participant unsuitable for the study. The following conditions do not lead to exclusion: (1) TG ≤ 3.42 mmol/L, TC ≤ 7.5 mmol/L, HDL-C abnormal; (2) alanine aminotransferase (ALT) \< 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) \< 1.5 × ULN, or total bilirubin \ 10 cigarettes/week or 2 cigarettes/day (or nicotine-equivalent, including e-cigarettes/vaping devices) within 3 months prior to Screening or who cannot stop using any nicotine products (including cigarettes, e-cigarettes/vaping devices, smokeless tobacco, and nicotine replacement therapy) during the study. A positive cotinine result, or the need for repeat testing, may be permitted at the Investigator's discretion; 16) Average daily consumption of excessive tea, coffee, and/or caffeine-containing beverages (more than 8 cups on average, 1 cup ≈ 250 mL) within 3 months prior to Screening, or inability to abstain during the study; 17) Strenuous exercise (e.g., weightlifting, sprinting, long-distance running, cycling, swimming, soccer) within 48 h prior to Screening; 18) History of drug abuse within 3 months prior to Screening, or positive drug abuse screening test. A positive drug abuse screening test result attributable to a documented medical history of prescribed medication may be permitted at the Investigator's discretion, following discussion with the Sponsor, provided the participant is not currently receiving such medication; 19) Has donated whole blood or had a loss of whole blood of more than 500 mL within the 30 days prior to Screening; has donated plasma (plasmapheresis) within 7 days prior to Screening; or has received a blood transfusion within one year prior to Screening; Participants with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venipuncture blood collection; 21) Participants who had special dietary requirements and could not accept a uniform diet and rest. The following dietary requirements will be accommodated: dairy/lactose-free, gluten-free, gluten-free and lactose-free, halal, no pork and beef, no red meat, no seafood, pescatarian, standard, vegan, and vegetarian; 22) Females who are pregnant, lactating, or have a positive serum pregnancy test during the Screening Period; 23) Participation in any other clinical study of drugs or medical devices within 3 months or 5 half-lives prior to Screening (whichever is longer), or planned participation in a clinical study of other drugs or medical devices during this study; 24) Participants whom the Investigator judges to have other factors that make them unsuitable to participate in the trial.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07776041). StuddyBuddy aggregates publicly available trial information.