SafetyPhase 1NCT07285967
A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet
A Phase 1 study testing Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug) in people with Safety and Tolerability, run by Hangzhou Yirui Pharmaceutical Technology Co., Ltd.
Trial summary
This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Pharmacokinetics
- What is being tested?
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who meet all the following criteria could be enrolled in this study:
- Written informed consent obtained from the participant in compliance with all local legal requirements.
- Male or female participant aged between 18 and 60 years (extremes included).
- Body mass index (BMI) between 18-32 kg/m2 (extremes included) and body weight less than 120 kg.
- Males must use a condom or remain abstinent during the trial and for 3 months after their last dose of study medication. And a fertile man's female partner must not try to become pregnant during the study.
- Female participants of childbearing potential must be established on a highly effective method of contraception (The recommended birth control methods are: Implantable (e.g. Implanon(r)), injectable (e.g. Depo-Provera(r)), insertable (e.g. NuvaRing®), Mirena (r) (LNG-IUS)), Combined oral contraceptives pill or progestin-only pill, Evra patch®, Intrauterine device (e.g. ParaGard(r), copper T) or Female sterilization, Male sterilization. The recommended birth control methods must be taken at least 3 weeks prior to screening (i.e., to ensure the contraceptive method has taken effect).) prior to dosing and until 3 months after their last dose in combination with male partner's use of a condom during the trial and for 3 months after the last dose.
- Free from any clinically relevant illness or disease that may adversely affect the safety of the participant, or the integrity of the study as determined by medical history, physical examination, safety laboratory, and other assessments.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Without other intestinal diseases such as irritable bowel syndrome and acute diarrhea due to any infection.
Who cannot join
- If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:
- Pregnant or lactating women.
- Participants with dysphagia.
- Severe infections requiring parenteral antibiotics treatment within 4 weeks prior to screening, e.g. sepsis, or severe pneumonia.
- Any clinically relevant conditions e.g. cerebral stroke, myocardial infarction, heart failure, unstable angina, and severe heart rate abnormalities within 6 months before screening.
- History or presence (within 6 months) of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Show all 20Show fewer
- Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).
- Presence of any renal impairment or dysfunction (i.e. estimated glomerular filtration rate (eGFR)<90 mL/ min).
- Presence of hepatic impairment: Child-Pugh A, B or C and/or transaminase levels that are outside the upper normal limit (i.e., Serum bilirubin ≥1.5× upper limit of normal (ULN), ALT or AST levels > ULN).
- diagnosis of diabetes regardless the degree of control at screening visit
- Hyperthyroidism or hypothyroidism.
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- Any major surgery within 6 months of screening.
- Participant has a positive test result of HBV (positive HBsAg), HCV (positive anti-HCV), or human immunodeficiency virus I and II (positive anti-HIV I/II), Treponema Pallidum antibody (positive anti-TP) at screening.
- Participants with innate or acquired immune system defects.
- Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).
- Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or a medically qualified sub-investigator.
- Participant has a QT interval with Fridericia's correction method (QTcF) >450 ms (males) or>470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit; or history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); or the use of concomitant medications that prolong the QT/QTc interval.
- Participant has a history of a major psychiatric illness or currently receiving therapy for a psychiatric condition Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.
- Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal [including traditional Chinese medicinal products] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration. etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A First-in-Human, Randomized, Double-Blinded, Placebo Controlled, SAD and MAD Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR011 Following Oral Administration.
This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants.
The trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8.
Read more
Key procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.
The trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase Ⅰ study. The purpose is to investigate the safety, tolerability, pharmacokinetics (PK) of YR011 in adult healthy participants following oral single and multiple ascending dose administration and the recommended dose to be used in the phase Ⅱ study.
This study consists of 2 stages:
Stage 1 (SAD):
The plan is to enroll approximately 32 eligible healthy participants in 4 cohorts. At least 4 cohorts will be studied, with approximately 8 participants in each cohort. Participants will be randomized at a 6:2 ratio to receive YR011 or placebo in a double-blind fashion, i.e. for 8 participants in a cohort, 6 participants will be randomized to receive active drug and 2 participants randomized to receive placebo. Sentinel dosing (1 participant to receive YR011 and 1 participant to receive placebo) will be used in each cohort to ensure adequate safety and tolerability evaluation before administering YR011 or placebo to the remainder of the participants within the cohort. After blinded review by the Safety Review Committee (SRC) of 24-hour post-dose safety and tolerability data from the sentinel group, the remaining 6 participants of each cohort may be dosed, provided that the adverse event (AE) profile in the sentinel participants is considered acceptable.
Four dose levels are planned. However, an additional cohort with a designated dose may be further studied if safety is confirmed in the previous cohorts, as decided by the SRC. The next dose level can only be studied after the SRC reviews the safety data of the previous dose level. For each participant, the drug will be administered once under fasting condition.
Pharmacokinetic blood samples will be collected up to 48 hours after dosing. Participants will be admitted to the Clinical Unit on Day -1, remain at the Clinical Unit until 48 hours post-dose on Day 3 (3 overnight stays), and will return 7 days after dosing for a Follow-up Visit.
The adjustment of the ascending dose will be based on the following rules:
Dose escalation will start from the lowest dose and proceed in the planned escalating sequence. After all participants have received the previous dose of the drug, the investigator and the sponsor will decide whether to escalate to the next dose level. In each dose group of participants, if 1/2 or more participants experience grade 2 or above adverse events (AEs, regardless of the AEs' relation to the study drug), or 1/3 or more participants experience grade 3 or above AEs (regardless of the AEs' relation to the study drug), or one or more participants experience serious adverse events (SAEs, regardless of the AEs' relation to the study drug), dose escalation will be terminated.
After the Stage 1 (SAD) is completed, the sponsor will decide whether to proceed with Stage 2 (MAD), suspend the study for an interim analysis, or terminate the study.
Stage 2(MAD):
There will be approximately 32 eligible healthy participants enrolled in 4 cohorts. Each cohort will include 8 participants. Participants will be randomized at a 6:2 ratio to receive YR011 or placebo in a double-blind fashion, i.e., for 8 participants in a cohort, 6 participants will be randomized to receive active drug and 2 participants randomized to receive placebo. Unlike the single-dose regimen, sentinel dosing within cohorts is not required in the multiple-dose regimen.
Four dose levels as decided by SRC are planned, and will be orally administered twice daily for 7 days, and 1 more dose on the 8th day, followed by a 7-day post-dose follow-up period under fasting condition. However, the dosage and administration method may be modified based on the findings in stage 1 and any new findings in stage 2. Pharmacokinetic blood samples will be collected up to 48 hours after dosing. Participants will be admitted to the Clinical Unit on Day -1, remain at the Clinical Unit until D10 (10 overnight stays), and will return 7 days after dosing for a Follow-up Visit.
The adjustment of the ascending dose will be based on the following rules:
Dose escalation will start from the lowest dose and proceed in the planned escalating sequence. After all participants have received the previous dose of the drug, the investigator and the sponsor will decide whether to escalate to the next dose level. In each dose group of participants, if 1/2 or more participants experience grade 2 or above adverse events (AEs, regardless of the AEs' relation to the study drug), or 1/3 or more participants experience grade 3 or above AEs (regardless of the AEs' relation to the study drug), or one or more participants experience serious adverse events (SAEs, regardless of the AEs' relation to the study drug), dose escalation will be terminated. Safety Review Committee (SRC) The SRC will be comprised of Independent, subject-matter-expert individuals (as qualified by education, training and experience to perform their respective task), not directly involved in the study conduct, for an unbiased review of the trial's emerging safety data and to help inform dose escalation decisions.
A pharmacokinetics expert and other participant matter experts may participate as needed. The SRC will be responsible for ongoing review of safety, tolerability, and clinical laboratory results, and available PK data, and deciding:
- To escalate to the next planned cohort or alternative dose levels (e.g., lower, intermediate, or higher) in single-dose cohorts (based on a review of available data, including at least 48 hours post-dose safety data and clinical laboratory results from each of the participants in the current cohort); 2) To escalate to the next planned cohort or alternative dose levels (e.g., lower, intermediate, or higher) in multiple-dose cohorts (based on a review of available data, including at least 48 hours post last dose safety data from each of the participants in the current cohort); 3) To add additional dose cohort(s) in either the single- or multiple-dose studies.
- To decide whether sentinel participants are needed in MAD cohorts. In addition, if ≥ 2 subjects on drug develop the same or similar AE of moderate intensity or if 1 subject develops a severe or serious AE that is considered possibly or probably related to study drug administration, further dosing will be withheld until the SRC investigates the events. Based on this assessment, the SRC will determine if the study should be terminated or continued and whether modification of planned dose levels and/or implementation of additional safety monitoring is indicated.
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Being tested
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug), Placebo
- Keywords
- KV1.3, YIRUI pharma, yirui, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)Drug
Highly selective Kv1.3 potassium channel blocker (active ingredient: PA032) - oral tablet formulation, administered as single ascending doses or multiple ascending doses (twice daily for 7 days + 1 extra dose on Day 8) under fasting conditions.
PlaceboDrug
The placebo intervention in this study is a matched oral tablet formulationcontaining inactive ingredients (e.g., excipients like microcrystalline cellulose, lactose) with no pharmacological activity.
| Study group | Role | What they receive |
|---|---|---|
| YR011 | Active comparator | Active arm: Participants receive the investigational drug YR011 at a specific dose. Receives: Drug: Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of treatment- Emergent adverse events (TEAE)
safety assessment will be based on the incidence of treatment- Emergent adverse events (TEAE) through out the treatment period and until the post-treatment follow-up period
Measured: From date of randomization until the last date of the post-treatment follow-up period, up to 44 days after informed consent.
Secondary outcomes (5)
Plasma concentration of YR011
blood samples will be taken at various timepoints before and after single and multiple dosing of the study drug
Measured: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Peak Plasma Concentration of YR011
blood samples will be taken at various timepoints before and after single and multiple dosing of the study drug to assess the Cmax of YR011
Measured: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Time to peak plasma concentration of YR011
blood samples will be taken at various timepoints before and after single and multiple dosing of the study drug to assess the Tmax of YR011
Measured: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Area under the plasma concentration versus time curve (AUC) of YR011
blood samples will be taken at various timepoints before and after single and multiple dosing of the study drug to assess the AUC of YR011
Measured: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Half life of YR011 (T1/2)
blood samples will be taken at various timepoints before and after single and multiple dosing of the study drug to assess the T1/2 of YR011
Measured: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Apr 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285967
- Sponsor's protocol ID
- YR011-B01
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azam P, Sankaranarayanan A, Homerick D, Griffey S, Wulff H. Targeting effector memory T cells with the small molecule Kv1.3 blocker PAP-1 suppresses allergic contact dermatitis. J Invest Dermatol. 2007 Jun;127(6):1419-29. doi: 10.1038/sj.jid.5700717. Epub 2007 Feb 1.
PubMed 17273162
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Randomized, Double-Blinded, Placebo Controlled, SAD and MAD Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of YR011 Following Oral Administration.
- ClinicalTrials.gov ID
- NCT07285967
- Acronym / sponsor ID
- YR011-B01
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Keywords
- KV1.3, YIRUI pharma, yirui, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Dec 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 I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants.
The trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8.
Key procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded.
The trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase Ⅰ study. The purpose is to investigate the safety, tolerability, pharmacokinetics (PK) of YR011 in adult healthy participants following oral single and multiple ascending dose administration and the recommended dose to be used in the phase Ⅱ study.
This study consists of 2 stages:
Stage 1 (SAD):
The plan is to enroll approximately 32 eligible healthy participants in 4 cohorts. At least 4 cohorts will be studied, with approximately 8 participants in each cohort. Participants will be randomized at a 6:2 ratio to receive YR011 or placebo in a double-blind fashion, i.e. for 8 participants in a cohort, 6 participants will be randomized to receive active drug and 2 participants randomized to receive placebo. Sentinel dosing (1 participant to receive YR011 and 1 participant to receive placebo) will be used in each cohort to ensure adequate safety and tolerability evaluation before administering YR011 or placebo to the remainder of the participants within the cohort. After blinded review by the Safety Review Committee (SRC) of 24-hour post-dose safety and tolerability data from the sentinel group, the remaining 6 participants of each cohort may be dosed, provided that the adverse event (AE) profile in the sentinel participants is considered acceptable.
Four dose levels are planned. However, an additional cohort with a designated dose may be further studied if safety is confirmed in the previous cohorts, as decided by the SRC. The next dose level can only be studied after the SRC reviews the safety data of the previous dose level. For each participant, the drug will be administered once under fasting condition.
Pharmacokinetic blood samples will be collected up to 48 hours after dosing. Participants will be admitted to the Clinical Unit on Day -1, remain at the Clinical Unit until 48 hours post-dose on Day 3 (3 overnight stays), and will return 7 days after dosing for a Follow-up Visit.
The adjustment of the ascending dose will be based on the following rules:
Dose escalation will start from the lowest dose and proceed in the planned escalating sequence. After all participants have received the previous dose of the drug, the investigator and the sponsor will decide whether to escalate to the next dose level. In each dose group of participants, if 1/2 or more participants experience grade 2 or above adverse events (AEs, regardless of the AEs' relation to the study drug), or 1/3 or more participants experience grade 3 or above AEs (regardless of the AEs' relation to the study drug), or one or more participants experience serious adverse events (SAEs, regardless of the AEs' relation to the study drug), dose escalation will be terminated.
After the Stage 1 (SAD) is completed, the sponsor will decide whether to proceed with Stage 2 (MAD), suspend the study for an interim analysis, or terminate the study.
Stage 2(MAD):
There will be approximately 32 eligible healthy participants enrolled in 4 cohorts. Each cohort will include 8 participants. Participants will be randomized at a 6:2 ratio to receive YR011 or placebo in a double-blind fashion, i.e., for 8 participants in a cohort, 6 participants will be randomized to receive active drug and 2 participants randomized to receive placebo. Unlike the single-dose regimen, sentinel dosing within cohorts is not required in the multiple-dose regimen.
Four dose levels as decided by SRC are planned, and will be orally administered twice daily for 7 days, and 1 more dose on the 8th day, followed by a 7-day post-dose follow-up period under fasting condition. However, the dosage and administration method may be modified based on the findings in stage 1 and any new findings in stage 2. Pharmacokinetic blood samples will be collected up to 48 hours after dosing. Participants will be admitted to the Clinical Unit on Day -1, remain at the Clinical Unit until D10 (10 overnight stays), and will return 7 days after dosing for a Follow-up Visit.
The adjustment of the ascending dose will be based on the following rules:
Dose escalation will start from the lowest dose and proceed in the planned escalating sequence. After all participants have received the previous dose of the drug, the investigator and the sponsor will decide whether to escalate to the next dose level. In each dose group of participants, if 1/2 or more participants experience grade 2 or above adverse events (AEs, regardless of the AEs' relation to the study drug), or 1/3 or more participants experience grade 3 or above AEs (regardless of the AEs' relation to the study drug), or one or more participants experience serious adverse events (SAEs, regardless of the AEs' relation to the study drug), dose escalation will be terminated. Safety Review Committee (SRC) The SRC will be comprised of Independent, subject-matter-expert individuals (as qualified by education, training and experience to perform their respective task), not directly involved in the study conduct, for an unbiased review of the trial's emerging safety data and to help inform dose escalation decisions.
A pharmacokinetics expert and other participant matter experts may participate as needed. The SRC will be responsible for ongoing review of safety, tolerability, and clinical laboratory results, and available PK data, and deciding:
- To escalate to the next planned cohort or alternative dose levels (e.g., lower, intermediate, or higher) in single-dose cohorts (based on a review of available data, including at least 48 hours post-dose safety data and clinical laboratory results from each of the participants in the current cohort); 2) To escalate to the next planned cohort or alternative dose levels (e.g., lower, intermediate, or higher) in multiple-dose cohorts (based on a review of available data, including at least 48 hours post last dose safety data from each of the participants in the current cohort); 3) To add additional dose cohort(s) in either the single- or multiple-dose studies.
- To decide whether sentinel participants are needed in MAD cohorts. In addition, if ≥ 2 subjects on drug develop the same or similar AE of moderate intensity or if 1 subject develops a severe or serious AE that is considered possibly or probably related to study drug administration, further dosing will be withheld until the SRC investigates the events. Based on this assessment, the SRC will determine if the study should be terminated or continued and whether modification of planned dose levels and/or implementation of additional safety monitoring is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YR011 | Active comparator | Drug: Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)Active arm: Participants receive the investigational drug YR011 at a specific dose. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants who meet all the following criteria could be enrolled in this study:
Key exclusion criteria (20 listed)
- If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:
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 |
|---|---|---|
| Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)Highly selective Kv1.3 potassium channel blocker (active ingredient: PA032) - oral tablet formulation, administered as single ascending doses or multiple ascending doses (twice daily for 7 days + 1 extra dose on Day 8) under fasting conditions. | Drug | YR011 |
| PlaceboThe placebo intervention in this study is a matched oral tablet formulationcontaining inactive ingredients (e.g., excipients like microcrystalline cellulose, lactose) with no pharmacological activity. | Drug | Placebo |
Primary outcome
The incidence of treatment- Emergent adverse events (TEAE)
Time frame: From date of randomization until the last date of the post-treatment follow-up period, up to 44 days after informed consent.
safety assessment will be based on the incidence of treatment- Emergent adverse events (TEAE) through out the treatment period and until the post-treatment follow-up period
5 secondary outcomes
Plasma concentration of YR011
Time frame: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Peak Plasma Concentration of YR011
Time frame: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Time to peak plasma concentration of YR011
Time frame: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Area under the plasma concentration versus time curve (AUC) of YR011
Time frame: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Half life of YR011 (T1/2)
Time frame: During treatment period from the first dose to the last dose (up to Maximum of 10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 17273162Azam P, Sankaranarayanan A, Homerick D, Griffey S, Wulff H. Targeting effector memory T cells with the small molecule Kv1.3 blocker PAP-1 suppresses allergic contact dermatitis. J Invest Dermatol. 2007 Jun;127(6):1419-29. doi: 10.1038/sj.jid.5700717. Epub 2007 Feb 1.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug) in people with Safety and Tolerability, run by Hangzhou Yirui Pharmaceutical Technology Co., Ltd.
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 8 inclusion and 20 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Wei (+86-751-86989512, kai.wei@yirui-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of treatment- Emergent adverse events (TEAE) (time frame: From date of randomization until the last date of the post-treatment follow-up period, up to 44 days after informed consent.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285967, which also lists 1 linked publication.
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 30 Jul 2026.