A Pharmacokinetic Study of YN001 in Healthy Participants
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Inno Medicine Co., Ltd.
About this trial
This is a Phase 1, single-center, open-label study designed to evaluate the pharmacokinetics (PK), safety, and immunogenicity following a single dose administration in healthy adult volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent must be obtained before any assessment is performed.
Healthy male and female adults aged from 18 to 65 years of age (inclusive) at time of Screening, and in good health as determined by no clinically significant (as judged by the PI/delegate) past medical history, physical examination, and vital signs, electrocardiogram (ECG), and laboratory tests at Screening and Baseline (Day -1).
tympanic body temperature between 35.5-37.7 °C
systolic blood pressure, 90-140 mm Hg (inclusive)
Disqualifiers
Received an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
Use of any prescription drugs, over the counter (OTC) medication, herbal supplements, dietary supplements (vitamins included), any type of vaccine within two weeks prior to the study drug administration, unless deemed acceptable by the Principal Investigator (or delegate) and agreement with the Sponsor.
Fasting triglyceride concentration >2.8 mmol/L at Screening or Baseline (Day -1).
A history of clinically significant ECG abnormalities, or any ECG abnormalities at Screening or Baseline (Day -1).
Trial design
Design model
Single group
Treatments tested in this trial
YN001
DrugYN001 administered via intravenous infusion. Participants will receive either 20 mg (Cohort 1) or 40 mg (Cohort 2).
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: YN001Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the maximum plasma concentration (Cmax) of YN001
Plasma concentration values will be measured to determine Cmax.
Time frame
From pre-dose (Day 1) through 120 hours post-dose (Day 6).2
To evaluate the time to reach maximum plasma concentration (Tmax) of YN001
Plasma concentration values will be measured to determine Tmax.
Time frame
From pre-dose (Day 1) through 120 hours post-dose (Day 6).3
To evaluate the area under the concentration-time curve from time 0 to last measurable concentration (AUC0-t) of YN001
Plasma concentration values will be used to calculate AUC0-t.
Time frame
From pre-dose (Day 1) through 120 hours post-dose (Day 6).4
To evaluate the area under the concentration-time curve extrapolated to infinity (AUCinf) of YN001
Plasma concentration values will be used to calculate AUCinf.
Time frame
From pre-dose (Day 1) through 120 hours post-dose (Day 6).Secondary outcomes
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and percentage of participants with treatment-emergent AEs and SAEs as assessed by CTCAE v5.0.
Time frame
Up to 15 days2
Incidence of Anti-PEG Antibodies (APA)
Characterization of anti-PEG antibodies, including the detection rate of pre-existing APAs and the emergence or boosting of treatment-induced APAs.
Time frame
From pre-dose (D1),Day 5, and Day 8.3
Change from Baseline in Laboratory Parameters
Number and percentage of participants with clinically significant abnormalities in hematology, chemistry, or urinalysis.
Time frame
Up to 15 days4
Change from Baseline in Electrocardiogram (ECG) Parameters
Number and percentage of participants with clinically significant ECG abnormalities after resting supine ≥5 minutes.
Time frame
Up to 15 daysSponsors and contacts
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Source ClinicalTrials.gov