A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus. NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Biomed Industries Pty Limited- Clinical Testing Site 1
Camperdown, New South Wales, Australia
Biomed Industries, Pty Limited Testing Site 2
Parkville, Victoria, Australia
Incidence of Treatment-Emergent Adverse Events in NA-931 participants
To evaluate the safety and tolerability of NA-931
Time frame: 28 days
Maximum observe drug concentration (Cmax) of NA-931
Pharmacokinetics (PK) Cmax
Time frame: 28 days
Effect of a High-Fat Meal on Plasma Concentration of NA-931
Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose
Time frame: 28 days
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