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A First-in-human Study of YN001 in Healthy Volunteers
This will be a single center, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study in healthy adult subjects.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-12-16
Primary completion: 2024-08-29
Study completion finish: 2024-08-29
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05635084
Intervention or treatment
DRUG: YN001
DRUG: Placebo for YN001
Conditions
- • Cardiovascular Diseases
Find a site
Closest Location:
Nucleus Network Pty Ltd
Research sites nearby
Select from list below to view details:
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: YN001
| DRUG: YN001
|
PLACEBO_COMPARATOR: Matching placebo for YN001
| DRUG: Placebo for YN001
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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. | Up to 15 days of last dose |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 168 hours of post initiation of last dose |
Immunogenicity | To evaluate the immunogenicity YN001 in healthy subjects. | Up to 168 hours of post initiation of last dose |
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