A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHangzhou Yirui Pharmaceutical Technology Co., Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
DrugHighly 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.
Placebo
DrugThe placebo intervention in this study is a matched oral tablet formulationcontaining inactive ingredients (e.g., excipients like microcrystalline cellulose, lactose) with no pharmacological activity.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: YR011Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From date of randomization until the last date of the post-treatment follow-up period, up to 44 days after informed consent.Secondary outcomes
1
Plasma concentration of YR011
blood samples will be taken at various timepoints before and after single and multiple dosing of the study drug
Time frame
During treatment period from the first dose to the last dose (up to Maximum of 10 days)2
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
Time frame
During treatment period from the first dose to the last dose (up to Maximum of 10 days)3
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
Time frame
During treatment period from the first dose to the last dose (up to Maximum of 10 days)4
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
Time frame
During treatment period from the first dose to the last dose (up to Maximum of 10 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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