A Study of SA030 Injection in Overweight or Obese Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSuzhou Siran Biotechnology Co.,Ltd.
About this trial
This study is the first time SA030 is being given to people. The goal is to understand how safe it is, how well it is tolerated, and how the body processes and responds to a single dose of SA030 in individuals who are overweight or obese.
Over the last few decades, more and more people around the world have become overweight or obese, and the numbers keep rising in almost every country. From 1990 to 2021, this problem grew steadily and reached its highest point in 2021.
Eligibility criteria
Qualifiers
You must be able to understand the study and sign a written consent form.
Men or women aged 18 to 55 years can join
Overweight or obese with a body mass index (BMI) between 25-40 kg/m²(inclusive);
You should be generally healthy, The study doctor will check your medical history, vital signs, physical exam, blood and urine tests, Electrocardiogram, and abdominal. ultrasound. Minor issues are okay if the doctor thinks they are not medically important.
Disqualifiers
You cannot join if you have lost or gained more than 5 percent of your body weight in the last 3 months.
You cannot participate if you previously had, or plan to have, weight-loss surgery or a weight-loss device during the study, except for the following procedures done more than 1 year before screening
Use of any over-the-counter medications, herbal supplements, or health products that may significantly affect weight or metabolism within 1 month prior to screening (e.g., orlistat, garcinia cambogia, ephedrine, etc.)
At screening, sitting systolic blood pressure more than of equals to 160 milli meters of mercury and/or diastolic blood pressure more than of equals to 100 mmHg, and deemed unsuitable for participation in this study by the investigator;
Trial design
Treatments tested in this trial
- Dose escalation of SA030
- Matching placebo of SA030
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov