A Pharmacokinetic Study of YN001 in Healthy Participants

NCT07190885 | Recruiting Phase 1

• 1 other identifier: YN001-103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• To evaluate the maximum plasma concentration (Cmax) of YN001

  Plasma concentration values will be measured to determine Cmax.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• To evaluate the time to reach maximum plasma concentration (Tmax) of YN001

  Plasma concentration values will be measured to determine Tmax.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• 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.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• To evaluate the area under the concentration-time curve extrapolated to infinity (AUCinf) of YN001

  Plasma concentration values will be used to calculate AUCinf.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• To evaluate the terminal elimination rate constant (λz) of YN001

  Plasma concentration values will be used to estimate λz.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• To evaluate the plasma half-life (T1/2) of YN001

  Plasma concentration values will be used to calculate T1/2.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• To evaluate the clearance (CL) of YN001

  Plasma concentration values will be used to calculate clearance.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

• To evaluate the volume of distribution (Vd) of YN001

  Plasma concentration values will be used to calculate volume of distribution.

  From pre-dose (Day 1) through 120 hours post-dose (Day 6).

Secondary Outcomes (6)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to 15 days

• Incidence of Anti-PEG Antibodies (APA)

  From pre-dose (D1),Day 5, and Day 8.

• Change from Baseline in Laboratory Parameters

  Up to 15 days

• Change from Baseline in Electrocardiogram (ECG) Parameters

  Up to 15 days

• Change from Baseline in Vital Signs

  Up to 15 days

Study Arms (1)

YN001

EXPERIMENTAL

Approximately 24 healthy male and female volunteers (18-65 years) will receive a single dose of YN001. Participants will be assigned to one of two dose cohorts: Cohort 1 - 20 mg (n=12) or Cohort 2 - 40 mg (n=12)

Drug: YN001

Interventions

YN001 DRUG

YN001 administered via intravenous infusion. Participants will receive either 20 mg (Cohort 1) or 40 mg (Cohort 2).

YN001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Vital signs (systolic and diastolic blood pressure and pulse rate) measurements within the below ranges at Screening and Baseline (Day -1):
• tympanic body temperature between 35.5-37.7 °C
• systolic blood pressure, 90-140 mm Hg (inclusive)
• diastolic blood pressure, 40-95 mm Hg (inclusive)
• pulse rate, 40-100 bpm (inclusive)
• Weigh at least 50 kg and have a body mass index (BMI) within the range of 18-32 kg/m2 at Screening and Baseline (Day -1).
• Meets contraception requirements.
• Willing and able to comply with the study requirements and restrictions.

You may not qualify if:

• 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).
• Pregnant or nursing (lactating) women.
• Average use of more than 5 cigarettes or equivalent nicotine containing products per week and/or unwilling to abstain from such products 7 days prior to study administration through until Day 15. Positive urine cotinine test at Baseline (Day -1); repeat testing may be permitted at PI/delegate discretion.
• History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by positive results for alcohol or drugs conducted at Screening and/or Baseline (Day -1). Alcohol abuse is defined as consumption of 14 or more standard drinks per week (where 1 unit = 375 mL of beer \[3.5% alc/vol\], 30 mL of 40% spirit or a 100 mL glass of wine \[13%\]). Any THC-containing products should not be used at least 7 days prior to Screening through until completion of Day 15.
• A positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus (HCV) or human immunodeficiency virus (HIV) test result at Screening.
• History of myopathy/myalgia, or susceptible to myopathy/rhabdomyolysis (e.g., hypothyroidism, family history of hereditary myopathy, previous muscle toxicity with HMG CoA reductase inhibitors or fibrates).
• Multiple drug allergies, or history of allergic reactions to study drug or any components of the study drug.
• Donation or loss of more than 400 ml of blood within 3 months prior to study drug administration.
• Plasma donation (\> 100 ml) within 60 days prior to first dosing.
• Hemoglobin levels below 120 g/L at Screening or Baseline (Day -1).
• Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
• Recent (within the last 3 years) and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), or cardiac dysfunction or myocardial infarction.

Sponsors & Collaborators

• Beijing Inno Medicine Co., Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

RECRUITING

Central Study Contacts

Kerry Xu

CONTACT

+18610343198; xuchuanying@innovmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: November 18, 2025
• Primary Completion: February 4, 2026
• Study Completion: February 18, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)