A Study of SA030 Injection in Overweight or Obese Participants

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SA030 Injection in Overweight or Obese Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight; Obese
• Intervention / Treatment: Drug: Dose escalation of SA030; Drug: Matching placebo of SA030

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr. Thomas Polasek; Phone Number: 0458162715; Email: Thomas.Polasek@cmax.com.au

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • CMAX Clinical Research Pty Ltd North Terrace
    • Contact: Dr. Thomas Metodey Polasek; Phone Number: 0458162715; Email: Thomas.Polasek@cmax.com.au
    • Principal Investigator: Dr. Thomas Metodey Polasek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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/m^2(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.
• For female participants of childbearing potential: must be non-pregnant and non- lactating, and agree to use highly effective contraception throughout the study period;
• For male participants of reproductive potential: must agree to use highly effective contraception during the study period to ensure effective contraception for sexual partners.

Exclusion Criteria:

• 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;
• Severe psychiatric disorders or uncontrolled psychiatric conditions, including but not limited to schizophrenia, bipolar disorder, or depression, deemed unsuitable for participation in this study by the investigator;
• If the screening ECG shows a prolonged QT/QTc interval, and a repeat test confirms QTcF greater than 450 ms in males or greater than 470 ms in females, the participant will be excluded
• Suffering from severe diseases, including but not limited to disorders of the nervous system, cardiovascular system, hematopoietic and lymphatic system, immune system, digestive system, urinary system, respiratory system, endocrine system, and history of malignancies, which the investigator judges may compromise safety or influence study results;
• Co-infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis; or prior diagnosis of hepatitis A, D, or E without resolution;
• Individuals who received a vaccine or live attenuated vaccine within 1 month prior to dosing, or who plan to receive a vaccine during the trial period; Major surgery within 6 months prior to screening, or planned surgery during the study period;
• Severe infection or trauma within 4 weeks prior to screening;
• Non-physiological blood loss more than or equals 200 milliliter within 1 month prior to study drug administration (including trauma, blood collection, or blood donation), or individuals planning to donate blood during the study period or within 60 days after dosing;
• History of severe intolerance to subcutaneous injections (mild reactions such as local swelling or redness are permissible);
• Individuals who have taken any prescription medication, herbal supplements, or over-the-counter drugs within 14 days prior to study drug administration;
• Participation in other drug clinical trials within 3 months of this study's treatment initiation, or within 5 half-lives of other investigational drug exposure, or participation in siRNA or antisense oligonucleotide drug clinical trials within 6 months prior to this study's treatment initiation (participants who withdrew from the study before receiving the investigational drug may be eligible for this study);
• Individuals who smoked more than 5 cigarettes or an equivalent amount of tobacco daily within 3 months prior to screening, or who are unable to abstain from smoking during the trial hospitalization period;
• Weekly alcohol consumption exceeding 14 units within 3 months prior to screening (1 unit of alcohol ≈360 milli Liter beer or 45 milli Liter 40 percent alcohol spirits or 150 milli Liter wine), or those with a positive breath alcohol test on the day before dosing (breath alcohol content more than 0.0 milligram per100 mL), or those unable to abstain from alcohol during the trial hospitalization period;
• Current or former drug users/substance abusers, or those with a positive urine drug screen on the day before dosing;
• Other factors deemed unsuitable for trial participation by the investigator, such as potential for poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation of SA030; Arm 1. single dose, 5 dose levels 1,2 3, 4 & 5	Drug: Dose escalation of SA030; Single dose, 5 dose levels
Placebo Comparator: Matching placebo of SA030; single dose, matching placebo	Drug: Matching placebo of SA030; Arm 2. single dose, matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs) and serious adverse events (SAEs)	Approximatly 6 months
Number of participants with clinical significant laboratory abnormalities	Approximatly 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Time to peak plasma concentration (Tmax)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Elimination half-life (t1/2)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Terminal elimination rate constant (λz)	Pharmacokinetic parameter:	Pre-dose, multiple timepoints post-dose up to Day 5
Apparent volume of distribution (Vd/F)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Apparent clearance (CL/F)	Pharmacokinetic parameter	Pre-dose, multiple timepoints post-dose up to Day 5
Number and percentage of participants developing immunogenicity (anti-SA030 antibodies)		Up to 6 months
Changes in weight		baseline, up to 24 weeks
Changes in BMI		baseline, up to 24 weeks
Changes in waist circumference		baseline, up to 24 weeks
Changes in hip circumference,		baseline, up to 24 weeks
Changes in waist-to-hip ratio		baseline, up to 24 weeks
Changes in body fat content		baseline, up to 24 weeks
Changes in ALK7 expression		baseline, up to 24 weeks
Change in QTcF relative to baseline and relative to placebo compared to baseline		From baseline to Day 13

Collaborators and Investigators

• Sponsor: Suzhou Siran Biotechnology Co.,Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 16, 2026
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): March 3, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ALK7
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: SAOB101-AUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No