CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.
A single-center, randomized double-blind, placebo-controlled, single-dose study Healthy volunteers were screened for up to 28 days prior to drug administration. The study included one dose group of 8 subjects. A single 5 mg/kg CM-101 dose was subcutaneously administered. The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42 days and an end of study (EOS) FU visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Incidence and characteristics of adverse events (AEs)
Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101
Time frame: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)
Maximum CM-101 plasma concentration (Cmax)
Time frame: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
Time to Cmax (tmax)
Time frame: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
Time frame: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination rate constant (λz)
Terminal elimination rate constant (λz)
Time frame: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
Terminal elimination half-life (T½)
Time frame: 10 weeks
Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) is attained within the tested doses range of CM-101
Time frame: 10 weeks
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Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
Assessment, based on the safety profile, whether maximum tolerated dose (MTD) is attained within the tested doses range of CM-101
Time frame: 10 weeks
Level of antibodies
Level of antibodies against CM-101
Time frame: 10 weeks