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
Qualifiers
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
Treatments tested in this trial
- YN001
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov