This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
A total of approximately 73 to 89 healthy male and female subjects will be enrolled into this study, it includes two parts: Part A is single ascending dose stage, approximately 49 to 65 healthy subjects will be enrolled into about eight to ten cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The doses will be progressively escalated, with a sentinel dosing strategy employed for all cohorts. Part B is multiple ascending dose stage, approximately 24 healthy subjects will be enrolled into about three cohorts. Subjects who meet eligibility criteria at screening will be admitted for baseline evaluations (Day -1). All baseline safety evaluation results must be available prior to dosing. The cohort M1 will be initiated by decision of SRC(safety review committee), then the doses will be progressively escalated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Dose ranges from 2-90mg
5% dextrose injection to mimic the YN001
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
The safety and tolerability of intravenously administered YN001 in healthy subjects.
To evaluate the incidence of Adverse Events as Assessed by CTCAE v5.0, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities, Clinically Significant Physical Examination Abnormalities and Infusion Reaction.
Time frame: Up to 15 days of last dose
Area under the plasma concentration-time curve from time 0 to the collection time point of the last measurable concentration (AUC0-t)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose
Area under the plasma concentration-time curve to infinity(AUCinf)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose
Maximum plasma concentration(Cmax)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose
Clearance(CL)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
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Time frame: Up to 168 hours of post initiation of last dose
Elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose
Volume of distribution estimates (Vdss)
To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose
Immunogenicity
To evaluate the immunogenicity YN001 in healthy subjects.
Time frame: Up to 168 hours of post initiation of last dose