GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
This is a first-in-human study. It is intended to provide the initial safety, pharmacokinetics (PK), and pharmacology data for GFB-024 in humans. This study will comprise a single ascending dose (SAD) escalation component in healthy overweight and obese volunteer participants and a repeat-dose component to confirm repeat-dose safety, tolerability, PK, and immunogenicity in participants with Type 2 diabetes mellitus. It will also explore potential cannabinoid-1 receptor (CB1) activity, participant selection, pharmacodynamics, and differential response biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Worldwide Clinical Trials
San Antonio, Texas, United States
Safety and tolerability following single ascending doses of GFB-024
Number of participants with serious and other nonserious adverse events
Time frame: Approximately 10 weeks
Safety and tolerability following repeated doses over 4 weeks of GFB-024
Number of participants with serious and other nonserious adverse events
Time frame: Approximately 13 weeks
Characterize PK of GFB-024 following single ascending doses (Cmax)
Maximum serum concentration
Time frame: Approximately 10 weeks
Characterize PK of GFB-024 following single ascending doses (AUClast)
Area under the serum concentration-time curve from time zero to last measurable concentration
Time frame: Approximately 10 weeks
Characterize PK of GFB-024 following repeated doses (Cmax)
Maximum serum concentration
Time frame: Approximately 13 weeks
Characterize PK of GFB-024 following repeated doses (AUClast)
Area under the serum concentration-time curve from time zero to last measurable concentration
Time frame: Approximately 13 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following single ascending doses
Number of participants with confirmed antidrug antibodies
Time frame: Approximately 10 weeks
Characterize the incidence and persistence of immunogenicity of GFB-024 following repeated doses
Number of participants with confirmed antidrug antibodies
Time frame: Approximately 13 weeks
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