HealthyPhase 1NCT06117514
Sudapyridine (WX-081) in Healthy Volunteers
A Phase 1 study testing Sudapyridine 30mg, Sudapyridine 100mg SAD and Sudapyridine 200mg SAD in people with Healthy, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sudapyridine 30mg, Sudapyridine 100mg SAD and Sudapyridine 200mg SAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2019to 2 Jul 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight: ≥50 kg; 19≤ body mass index (BMI) < 26 kg/m2;
- Considered healthy by the investigator based on a detailed history, thorough physical examination, clinical laboratory examination, 12-lead ECG, and vital signs results;
- No parenting plan and reliable contraception during the trial period and within 3 months after the last dose.
Who cannot join
- Allergic to any drug of the same category or its ingredients;
- A history of alcohol dependence or drug abuse;
- Laboratory obvious abnormalities;
- CYP3A4 potent inducer or inhibitor had been taken within 30 days prior to enrollment;
- Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-ascending Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Sudapyridine (WX-081) Tablets in Healthy Chinese Subjects
The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.
Read the detailed description
In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.
This study was divided into two stages. The first stage evaluated the tolerance of single administration, pharmacokinetic characteristics, and the effect of food on PK. The second stage evaluated the tolerance of multiple administration and PK characteristics.
- Conditions
- Healthy
- Being tested
- Sudapyridine 30mg, Sudapyridine 100mg SAD, Sudapyridine 200mg SAD, Sudapyridine 200mg MAD, Sudapyridine 300mg MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudapyridine 30mgDrug
Also called Sudapyridine capsule 30mg SAD
Sudapyridine capsule 30mg, orally, single dose
Sudapyridine 100mg SADDrug
Also called Sudapyridine tablet 100mg SAD
Sudapyridine tablet, 100mg orally, single dose
Sudapyridine 200mg SADDrug
Also called Sudapyridine tablet 200mg SAD
Sudapyridine tablet, 200mg orally, single dose
Sudapyridine 200mg MADDrug
Also called Sudapyridine tablet 200mg MAD
Sudapyridine tablet, 200mg orally once a day for 14 days
Sudapyridine 300mg MADDrug
Also called Sudapyridine tablet 300mg MAD
Sudapyridine tablet, 300mg orally once a day for 14 days
Placebo tablet SADOther
Also called Placebo tablet 100mg
Placebo tablet, 100mg orally, single dose
Placebo 200mg SADOther
Placebo tablet, 200mg orally, single dose
Placebo tablet MADOther
Also called Placebo tablet 200mg MAD
Placebo tablet, 200mg orally once a day for 14 days
Placebo tablet MADOther
Also called Placebo tablet 300mg MAD
Placebo tablet, 300mg orally once a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sudapyridine 30 mg single dose | Experimental | Participants received Sudapyridine 30 mg single dose orally. Receives: Drug: Sudapyridine 30mg |
| Sudapyridine 100 mg single dose | Experimental | Participants received Sudapyridine 100 mg single dose orally. Receives: Drug: Sudapyridine 100mg SAD |
| Sudapyridine 200 mg single dose | Experimental | Participants received Sudapyridine 200 mg single dose orally. Receives: Drug: Sudapyridine 200mg SAD |
| Sudapyridine 200 mg multiple doses | Experimental | Participants received Sudapyridine 200 mg orally for multiple doses. Receives: Drug: Sudapyridine 200mg MAD |
| Sudapyridine 300 mg multiple doses | Experimental | Participants received Sudapyridine 300 mg orally for multiple doses. Receives: Drug: Sudapyridine 300mg MAD |
| Placebo 100 mg single dose | Placebo comparator | Participants received Placebo 100 mg single dose orally. Receives: Other: Placebo tablet SAD |
| Placebo 200 mg single dose | Placebo comparator | Participants received Placebo 200 mg single dose orally. Receives: Other: Placebo 200mg SAD |
| Placebo 200 mg multiple doses | Placebo comparator | articipants received Placebo 200 mg orally for multiple doses. Receives: Other: Placebo tablet MAD |
| Placebo 300mg multiple doses | Placebo comparator | Participants received Placebo 300 mg orally for multiple doses. Receives: Other: Placebo tablet MAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Time to reach plasma Cmax (Tmax) of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Area under the plasma concentration-time curve (AUC) of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Terminal elimination half-life (t½) of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Volume of distribution (Vd/F) of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Apparent clearance (CL/F) of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Elimination rate constant Ke of Sudapyridine
PK parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
safety parameter
Measured: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start13 Feb 2019
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Liu, Principal investigator, Shanghai Xuhui District Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117514
- Sponsor's protocol ID
- JYB0101
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-ascending Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Sudapyridine (WX-081) Tablets in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06117514
- Acronym / sponsor ID
- JYB0101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 7 Nov 2023 (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.
The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.
Detailed description
In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.
This study was divided into two stages. The first stage evaluated the tolerance of single administration, pharmacokinetic characteristics, and the effect of food on PK. The second stage evaluated the tolerance of multiple administration and PK characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Sudapyridine 30 mg single dose | Experimental | Drug: Sudapyridine 30mgParticipants received Sudapyridine 30 mg single dose orally. |
| Sudapyridine 100 mg single dose | Experimental | Drug: Sudapyridine 100mg SADParticipants received Sudapyridine 100 mg single dose orally. |
| Sudapyridine 200 mg single dose | Experimental | Drug: Sudapyridine 200mg SADParticipants received Sudapyridine 200 mg single dose orally. |
| Sudapyridine 200 mg multiple doses | Experimental | Drug: Sudapyridine 200mg MADParticipants received Sudapyridine 200 mg orally for multiple doses. |
| Sudapyridine 300 mg multiple doses | Experimental | Drug: Sudapyridine 300mg MADParticipants received Sudapyridine 300 mg orally for multiple doses. |
| Placebo 100 mg single dose | Placebo comparator | Other: Placebo tablet SADParticipants received Placebo 100 mg single dose orally. |
| Placebo 200 mg single dose | Placebo comparator | Other: Placebo 200mg SADParticipants received Placebo 200 mg single dose orally. |
| Placebo 200 mg multiple doses | Placebo comparator | Other: Placebo tablet MADarticipants received Placebo 200 mg orally for multiple doses. |
| Placebo 300mg multiple doses | Placebo comparator | Other: Placebo tablet MADParticipants received Placebo 300 mg orally for multiple doses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Weight: ≥50 kg; 19≤ body mass index (BMI) < 26 kg/m2;
- Considered healthy by the investigator based on a detailed history, thorough physical examination, clinical laboratory examination, 12-lead ECG, and vital signs results;
- No parenting plan and reliable contraception during the trial period and within 3 months after the last dose.
Key exclusion criteria (5 listed)
- Allergic to any drug of the same category or its ingredients;
- A history of alcohol dependence or drug abuse;
- Laboratory obvious abnormalities;
- CYP3A4 potent inducer or inhibitor had been taken within 30 days prior to enrollment;
- Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.
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 |
|---|---|---|
| Sudapyridine 30mgAlso: Sudapyridine capsule 30mg SADSudapyridine capsule 30mg, orally, single dose | Drug | Sudapyridine 30 mg single dose |
| Sudapyridine 100mg SADAlso: Sudapyridine tablet 100mg SADSudapyridine tablet, 100mg orally, single dose | Drug | Sudapyridine 100 mg single dose |
| Sudapyridine 200mg SADAlso: Sudapyridine tablet 200mg SADSudapyridine tablet, 200mg orally, single dose | Drug | Sudapyridine 200 mg single dose |
| Sudapyridine 200mg MADAlso: Sudapyridine tablet 200mg MADSudapyridine tablet, 200mg orally once a day for 14 days | Drug | Sudapyridine 200 mg multiple doses |
| Sudapyridine 300mg MADAlso: Sudapyridine tablet 300mg MADSudapyridine tablet, 300mg orally once a day for 14 days | Drug | Sudapyridine 300 mg multiple doses |
| Placebo tablet SADAlso: Placebo tablet 100mgPlacebo tablet, 100mg orally, single dose | Other | Placebo 100 mg single dose |
| Placebo 200mg SADPlacebo tablet, 200mg orally, single dose | Other | Placebo 200 mg single dose |
| Placebo tablet MADAlso: Placebo tablet 200mg MADPlacebo tablet, 200mg orally once a day for 14 days | Other | Placebo 200 mg multiple doses |
| Placebo tablet MADAlso: Placebo tablet 300mg MADPlacebo tablet, 300mg orally once a day for 14 days | Other | Placebo 300mg multiple doses |
Primary outcome
Maximum plasma concentration (Cmax) of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Time to reach plasma Cmax (Tmax) of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Area under the plasma concentration-time curve (AUC) of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Terminal elimination half-life (t½) of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Volume of distribution (Vd/F) of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Apparent clearance (CL/F) of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Elimination rate constant Ke of Sudapyridine
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
PK parameter
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
safety parameter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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. This study is not recruiting at the moment.
Yun Liu principal investigator
Shanghai Xuhui District Central Hospital
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 Sudapyridine 30mg, Sudapyridine 100mg SAD and Sudapyridine 200mg SAD in people with Healthy, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 7 Nov 2023. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum plasma concentration (Cmax) of Sudapyridine (time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose). 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 7 Nov 2023.