A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) \< 3 that are in general good health and have normal liver functions to be treated with CM-101.
This study is designed to assess the safety and preliminary pharmacodynamics of repeated administrations of CM-101 in two subject populations. The objective of part one of this study is to demonstrate that repeated treatment with CM-101 will be safe and well tolerated in NAFLD subjects that have normal liver functions and are in general good health. A second expansion part will be carried out that will include patients with NAFLD/NASH Activity Score (NAS) \< 3 that are in general good health and have normal liver functions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Anti-human CCL24 monoclonal antibody (CM-101) - Part One
Anti-human CCL24 monoclonal antibody (CM-101) - Part Two
Placebo Comparator
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
Incidence and characteristics of adverse events (AEs) occurring following multiple doses
Incidence and characteristics of adverse events (AEs) occurring following multiple doses
Time frame: Up to 18 weeks
Evaluation of the development of anti-drug antibodies (ADA) - Study Part 1
Evaluation of the development of anti-drug antibodies (ADA) following repeated administrations of CM-101 -
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Maximum CM-101 plasma concentration (Cmax) - Study Part 1
Plasma PK parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 - Time to Cmax (tmax) - Study Part 1
Plasma PK parameters of CM-101 following multiple administrations - Time to Cmax (tmax)
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf - Study Part 1
Plasma PK parameters of CM-101 following multiple administrations - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Terminal elimination rate constant (λz) - Study Part 1
Plasma PK parameters of CM-101 - Terminal elimination rate constant (λz)
Time frame: Up to 18 weeks
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Placebo Comparator
Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Terminal elimination half-life (T½) - Study Part 1
Plasma PK parameters of CM-101 - Terminal elimination half-life (T½)
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Maximum CM-101 plasma concentration (Cmax) - Study Part 2
Plasma PK parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Time to Cmax (tmax) - Study Part 2
Plasma PK parameters of CM-101 - Time to Cmax (tmax)
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf - Study Part 2
Plasma PK parameters of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 - Terminal elimination rate constant (λz) - Study Part 2
Plasma PK parameters of CM-101 following multiple administrations - Terminal elimination rate constant (λz)
Time frame: Up to 18 weeks
Plasma Pharmacokinetics (PK) parameters of CM-101 - Terminal elimination half-life (T½) - Study Part 2
Plasma PK parameters of CM-101 following multiple administrations - Terminal elimination half-life (T½)
Time frame: Up to 18 weeks
Evaluation of the development of anti-drug antibodies (ADA) following repeated administrations of CM-101 - Study Part 2
Evaluation of the development of anti-drug antibodies (ADA) of CM-101
Time frame: Up to 18 weeks
Liver function test: ALT (alanine aminotransferase) - Study Part 2 Only
Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - ALT (alanine aminotransferase)
Time frame: Over a treatment period of 18 weeks
Liver function test: AST (Aspartate Aminotransferase) - Study Part 2 Only
Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - Liver function test: AST (Aspartate Aminotransferase)
Time frame: Over a treatment period of 18 weeks
Liver function test: GGT (gamma-glutamyltransferase) - Study Part 2 Only
Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - Liver function test: GGT (gamma-glutamyltransferase)
Time frame: Over a treatment period of 18 weeks
Liver function test: ALP (Alkaline Phosphatase) - Study Part 2 Only
Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - Liver function test:ALP (Alkaline Phosphatase)
Time frame: Over a treatment period of 18 weeks
Change from baseline to end of treatment in: fibrosis-4 (FIB-4) score - Study Part 2 Only
Change from baseline to end of treatment in: fibrosis-4 (FIB-4) score
Time frame: Up to 15 Weeks
Change from baseline to end of treatment in: Aspartate transaminase (AST) ratio - Study Part 2 Only
Change from baseline to end of treatment in: AST ratio
Time frame: Up to 15 Weeks
Change from baseline to end of treatment in: Alanine aminotransferase (ALT) ratio - Study Part 2 Only
Change from baseline to end of treatment in: ALT ratio
Time frame: Up to 15 Weeks
Change from baseline to end of treatment in: APRI (AST to platelet ratio index) - Study Part 2 Only
Change from baseline to end of treatment in: APRI (AST to platelet ratio index)
Time frame: Up to 15 Weeks
Change from baseline to end of treatment in: Nonalcoholic fatty liver disease (NAFLD) Fibrosis Score - Study Part 2 Only
Change from baseline to end of treatment in: NAFLD Fibrosis Score
Time frame: Up to 15 Weeks