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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Single dose, 5 dose levels
Arm 2. single dose, matching placebo
CMAX Clinical Research Pty Ltd North Terrace
Adelaide, Australia
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Approximatly 6 months
Number of participants with clinical significant laboratory abnormalities
Time frame: Approximatly 6 months
Peak plasma concentration (Cmax)
Pharmacokinetic parameter
Time frame: Pre-dose, multiple timepoints post-dose up to Day 5
Time to peak plasma concentration (Tmax)
Pharmacokinetic parameter
Time frame: 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
Time frame: Pre-dose, multiple timepoints post-dose up to Day 5
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
Elimination half-life (t1/2)
Pharmacokinetic parameter
Time frame: Pre-dose, multiple timepoints post-dose up to Day 5
Terminal elimination rate constant (λz)
Pharmacokinetic parameter:
Time frame: Pre-dose, multiple timepoints post-dose up to Day 5
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Apparent volume of distribution (Vd/F)
Pharmacokinetic parameter
Time frame: Pre-dose, multiple timepoints post-dose up to Day 5
Apparent clearance (CL/F)
Pharmacokinetic parameter
Time frame: Pre-dose, multiple timepoints post-dose up to Day 5
Number and percentage of participants developing immunogenicity (anti-SA030 antibodies)
Time frame: Up to 6 months
Changes in weight
Time frame: baseline, up to 24 weeks
Changes in BMI
Time frame: baseline, up to 24 weeks
Changes in waist circumference
Time frame: baseline, up to 24 weeks
Changes in hip circumference,
Time frame: baseline, up to 24 weeks
Changes in waist-to-hip ratio
Time frame: baseline, up to 24 weeks
Changes in body fat content
Time frame: baseline, up to 24 weeks
Changes in ALK7 expression
Time frame: baseline, up to 24 weeks
Change in QTcF relative to baseline and relative to placebo compared to baseline
Time frame: From baseline to Day 13