This research study is studying an investigational drug called FCN-207 in healthy adult males or females.
This is a Phase 1, single-center, dose-escalations (SAD and MAD) and food effect study of FCN-207: Part 1 Single Ascending Dose (SAD) study: randomized, double-blind, placebo-controlled. Part 2 Food-effect study: single-dose, two-treatment (fasted vs. high-fat meal), two-sequence crossover design. Part 3 Multiple Ascending Dose (MAD) study: randomized, double-blind, placebo-controlled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Peking university Third Hospital
Beijing, Beijing Municipality, China
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria
Time frame: Up to week 4
To determine the occurrence of treatment-emergent adverse events (TEAs)
Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria
Time frame: Up to week 4
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period (single ascending doses group:7 days ,multiple ascending doses:21 days) of study treatment . Treatment related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).
Time frame: Up to week 4
Pharmacokinetics (AUC: Area under the plasma concentration-time curve)
Time frame: 2 weeks
Pharmacokinetics (Cmax: Maximum plasma concentration)
Time frame: 2 weeks
Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)
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Time frame: 2 weeks
Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)
Time frame: 2 weeks
Pharmacokinetics (CL/F)
Time frame: 2 weeks
Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)
Time frame: 2 weeks
Pharmacokinetics (λz:Elimination rate constant)
Time frame: 2 weeks
Pharmacokinetics (DF)
Time frame: 2 weeks
Pharmacokinetics (RCmax: Cmax accumulation multiple consecutive times)
Time frame: 2 weeks
Pharmacokinetics (RAUC:AUC accumulation multiple consecutive times)
Time frame: 2 weeks