Health TrialsbyHealthPanel

A Study of SA030 Injection in Overweight or Obese Participants

ConditionsObeseOverweight
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Dose escalation of SA030

    Drug

    Single dose, 5 dose levels

  • Matching placebo of SA030

    Drug

    Arm 2. single dose, matching placebo

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Dose escalation of SA030Experimental treatment 1 intervention
Group B: Matching placebo of SA030Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Time frame
Approximatly 6 months
2

Number of participants with clinical significant laboratory abnormalities

Time frame
Approximatly 6 months

Secondary outcomes

1

Peak plasma concentration (Cmax)

Pharmacokinetic parameter

Time frame
Pre-dose, multiple timepoints post-dose up to Day 5
2

Time to peak plasma concentration (Tmax)

Pharmacokinetic parameter

Time frame
Pre-dose, multiple timepoints post-dose up to Day 5
3

Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)

Pharmacokinetic parameter

Time frame
Pre-dose, multiple timepoints post-dose up to Day 5
4

Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)

Pharmacokinetic parameter

Time frame
Pre-dose, multiple timepoints post-dose up to Day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Siran Biotechnology Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: