A Study of SYH2092 Injection in Healthy Participants
ConditionOverweight or Obesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
To evaluate the safety and tolerability of SYH2092 Injection in healthy participants
Eligibility criteria
Qualifiers
Fully understand the content, process and possible adverse drug reactions (ADRs) of the study before the study, and voluntarily sign the ICF;
At Screening, aged 18 to 60 years (inclusive, based on the date of signing the ICF), including both males and females;
At Screening, body weight ≥ 50 kg with a body mass index (BMI) of 18 to 35 kg/m²
Body weight change ≤ 5% within 3 months prior to Screening (including the Screening Period) (based on participant self-report);
Disqualifiers
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);
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 <1.5 × ULN;
HbA1c ≥ 6.5% during Screening Period, or fasting glucose < 3.9 mmol/L or ≥ 7 mmol/L;
Prolonged QTcF interval during Screening Period (≥ 450 ms for males; ≥ 460 ms for females; see Section 13.5 for calculation formula), history of risk factors for Torsades de Pointes (e.g., cardiac failure/cardiomyopathy, or family history of long QT syndrome);
Trial design
Treatments tested in this trial
- SYH2092 Injection
- Placebo
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov