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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of SA030 | Experimental | Arm 1. single dose, 5 dose levels 1,2 3, 4 & 5 |
|
| Matching placebo of SA030 | Placebo Comparator | single dose, matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose escalation of SA030 | Drug | Single dose, 5 dose levels |
| |
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Polasek | Contact | 0458162715 | Thomas.Polasek@cmax.com.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd North Terrace | Adelaide | 5000 | Australia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Matching placebo of SA030 |
| Drug |
Arm 2. single dose, matching placebo |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |