The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.
The study is a single ascending dose study, with participants monitored for 9 months after administration. This clinical trial will seek to address the following: * Which dose of the study drug is most effective. * How safe the study drug is and how well participants tolerate it. * How much of the study drug can be found in blood (pharmacokinetics). * How the study drug affects the body (pharmacodynamics). * How the body's immune system responds to the study drug (immunogenicity). * How the body's composition and physical function may change over the course of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Veritus Research
Bayswater, Victoria, Australia
RECRUITINGAssessment of the safety and tolerability of a single dose of IBIO-600
Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs.
Time frame: From Day 1 through Day 252 (end of study).
Pharmacokinetics of a single dose of IBIO-600
Maximum observed serum concentration (Cmax)
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Time to maximum concentration (Tmax)
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Area under the curve (AUC)
Time frame: Baseline to the last measurable concentration (AUC0-last)
Pharmacokinetics of a single dose of IBIO-600
AUC
Time frame: Baseline to infinity (AUC0-inf)
Pharmacokinetics of a single dose if IBIO-600
t½: half-life
Time frame: Baseline up to Week 36
Pharmacokinetics of a single dose of IBIO-600
Apparent total body clearance (CL/F)
Time frame: Baseline through Week 36
Pharmacokinetics of a single dose of IBIO-600
Apparent volume of distribution (Vz/F)
Time frame: Baseline up to Week 36
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Pharmacodynamics (PD) of a single dose of IBIO-600
Change in circulating concentrations of total GDF8
Time frame: Baseline through Week 36
Pharmacodynamics of a single dose of IBIO-600
Change in circulating concentrations of total GDF11
Time frame: Baseline up to Week 36
Pharmacodynamics of a single dose of IBIO-600
Change in lipid panel tests
Time frame: Baseline up to Week 36