Healthy VolunteersPhase 1NCT07190885
A Pharmacokinetic Study of YN001 in Healthy Participants
A Phase 1 study testing YN001 in people with Healthy Volunteers, run by Beijing Inno Medicine Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- YN001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Nov 2025to Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
- History of significant food allergies (e.g. anaphylactic reactions). Mild (non-anaphylactic, hypersensitivity) food allergies such as lactose intolerance/glucose intolerance are permitted.
- Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in case of participation in the study. The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following:
- Inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding in the last 6 months.
- Pancreatic injury or pancreatitis in the last 6 months.
- Liver disease or liver injury as indicated by abnormal liver function tests at Screening or Baseline (Day -1) such as SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase (ALP), or total bilirubin. The Investigator should be guided by the following criteria:
- Any single parameter of ALT, AST, GGT, ALP, or total bilirubin must not exceed 1.5 x upper limit of normal (ULN).
- History or presence of impaired renal function as indicated by abnormal creatinine and/or urea values (e.g., eGFR<90 mL/min/1.73 m2 (calculated by CKD-EPI equation), or abnormal urinary constituents (e.g., albuminuria), deemed clinically significant by the PI/delegate at Screening or Baseline (Day -1).
- Evidence of urinary obstruction or difficulty in voiding at Screening.
- Significant illness resolved within two weeks prior to dosing, which may affect the study drug administration and safety assessments in the opinion of the PI/delegate.
- Any other medical condition or social circumstance, which in the opinion of the PI/delegate would impede compliance with or hinder completion of the study or otherwise deem the participant unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This will be a single center, open-label, single dose study in Healthy volunteers.
A total of approximately 24 healthy male and female participants will be enrolled into two dose groups (12 participants per dose group).
The study will consist of a maximum 27-day screening period, a baseline period (Day -1), a treatment period (Day 1), a follow up period (Day 2-15). After completion of relevant assessments on Day 8, participants will be followed for an additional 7 days and will have a completion visit conducted via phone call on Day 15.
The study is designed to refine PK profile of YN001 in Australian healthy volunteers to support further clinical development of YN001.
- Conditions
- Healthy Volunteers
- Being tested
- YN001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YN001Drug
YN001 administered via intravenous infusion. Participants will receive either 20 mg (Cohort 1) or 40 mg (Cohort 2).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: YN001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the maximum plasma concentration (Cmax) of YN001
Plasma concentration values will be measured to determine Cmax.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Number and percentage of participants with treatment-emergent AEs and SAEs as assessed by CTCAE v5.0.
Measured: Up to 15 days
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.
Measured: From pre-dose (D1),Day 5, and Day 8.
Change from Baseline in Laboratory Parameters
Number and percentage of participants with clinically significant abnormalities in hematology, chemistry, or urinalysis.
Measured: Up to 15 days
Change from Baseline in Electrocardiogram (ECG) Parameters
Number and percentage of participants with clinically significant ECG abnormalities after resting supine ≥5 minutes.
Measured: Up to 15 days
Change from Baseline in Vital Signs
Number and percentage of participants with clinically significant abnormalities in systolic and diastolic blood pressure, pulse, and body temperature.
Measured: Up to 15 days
Change from Baseline in Physical Examination Findings
Number and percentage of participants with clinically significant abnormalities in physical exam findings.
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start18 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: The study was suspended at the request of the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190885
- Sponsor's protocol ID
- YN001-103
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of YN001 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07190885
- Acronym / sponsor ID
- YN001-103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study was suspended at the request of the Sponsor.
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a single center, open-label, single dose study in Healthy volunteers.
A total of approximately 24 healthy male and female participants will be enrolled into two dose groups (12 participants per dose group).
The study will consist of a maximum 27-day screening period, a baseline period (Day -1), a treatment period (Day 1), a follow up period (Day 2-15). After completion of relevant assessments on Day 8, participants will be followed for an additional 7 days and will have a completion visit conducted via phone call on Day 15.
The study is designed to refine PK profile of YN001 in Australian healthy volunteers to support further clinical development of YN001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YN001 | Experimental | Drug: YN001Approximately 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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):
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YN001YN001 administered via intravenous infusion. Participants will receive either 20 mg (Cohort 1) or 40 mg (Cohort 2). | Drug | YN001 |
Primary outcome
To evaluate the maximum plasma concentration (Cmax) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be measured to determine Cmax.
To evaluate the time to reach maximum plasma concentration (Tmax) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be measured to determine Tmax.
To evaluate the area under the concentration-time curve from time 0 to last measurable concentration (AUC0-t) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be used to calculate AUC0-t.
To evaluate the area under the concentration-time curve extrapolated to infinity (AUCinf) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be used to calculate AUCinf.
To evaluate the terminal elimination rate constant (λz) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be used to estimate λz.
To evaluate the plasma half-life (T1/2) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be used to calculate T1/2.
To evaluate the clearance (CL) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be used to calculate clearance.
To evaluate the volume of distribution (Vd) of YN001
Time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).
Plasma concentration values will be used to calculate volume of distribution.
6 secondary outcomes
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 15 days
Incidence of Anti-PEG Antibodies (APA)
Time frame: From pre-dose (D1),Day 5, and Day 8.
Change from Baseline in Laboratory Parameters
Time frame: Up to 15 days
Change from Baseline in Electrocardiogram (ECG) Parameters
Time frame: Up to 15 days
Change from Baseline in Vital Signs
Time frame: Up to 15 days
Change from Baseline in Physical Examination Findings
Time frame: Up to 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YN001 in people with Healthy Volunteers, run by Beijing Inno Medicine Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the maximum plasma concentration (Cmax) of YN001 (time frame: From pre-dose (Day 1) through 120 hours post-dose (Day 6).). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.