Gout ArthritisPhase 1NCT06277752
A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor)
A Phase 1 study testing dose-5 group, dose-1 group and dose-2 group in people with Gout Arthritis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout Arthritis
- What is being tested?
- dose-5 group, dose-1 group and dose-2 group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2024to 16 Mar 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 50 years at screening;
- Subjects with a Body Mass Index (BMI) between 18.0 (inclusive) and 28.0 kg/m2 (inclusive); and a total body weight ≥55kg (male） and 45kg (female)
- Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
- Subject is willing to participate and to Sign written informed consent form.
Who cannot join
- Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
- Subjects with evidence or a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except simple appendectomy or repair of hernia) that may influence drug absorption
- Subjects with evidence or a history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (mood disorder, obsessive-compulsive disorder, etc.) diseases.
- Subjects with a history or current have mental disease.
- Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
- Subject who have taken IBI128 in other studies.
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- Subjects who have a history of acute arthiritis.
- Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.
- Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects
A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
- Conditions
- Gout Arthritis
- Being tested
- dose-5 group, dose-1 group, dose-2 group, dose-4 group, dose-3 group
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dose-5 groupDrug
IBI128 300mg po. QD(Quaque Die)
dose-1 groupDrug
IBI128 25mg po. QD(Quaque Die)
dose-2 groupDrug
IBI128 50mg po. QD(Quaque Die)
dose-4 groupDrug
IBI128 200mg po. QD(Quaque Die)
dose-3 groupDrug
IBI128 100mg po. QD(Quaque Die)
| Study group | Role | What they receive |
|---|---|---|
| IBI128 | Experimental | IBI128 po. QD(Quaque Die) Receives: Drug: dose-5 group; Drug: dose-1 group; Drug: dose-2 group; Drug: dose-4 group; Drug: dose-3 group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter: Cmax
Maximum plasma concentration(Cmax) of IBI128
Measured: Up to Day 8
PK parameter: AUC
Area under the concentration-time curve （AUC）of IBI128
Measured: Up to Day 8
PK parameter: Tmax
Time to ahieve Cmax
Measured: Up to Day 8
PK parameter: T1/2
The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.
Measured: Up to Day 8
Secondary outcomes (3)
Safety parameter: AE
Number of subjects with Adverse Event
Measured: Up to Day 8
PD parameter: serum UA (uric acid）
The Percentage change of serum UA assesed by Area Under Curve 24，Cmean,24，Cmean,24 of IBI128 from baseline.
Measured: Up to Day 8
Tolerability parameter: SAE
Number of subjects with Serious Adverse Event
Measured: Up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start5 Mar 2024
- Primary completion16 Mar 2024
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout ArthritisStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277752
- Sponsor's protocol ID
- CIBI128A101
- Status last verified
- Mar 2024
- First submitted
- 4 Feb 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06277752
- Acronym / sponsor ID
- CIBI128A101
- Conditions
- Gout Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 26 Feb 2024 (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.
A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI128 | Experimental | Drug: dose-5 group, Drug: dose-1 group, Drug: dose-2 group, Drug: dose-4 group, Drug: dose-3 groupIBI128 po. QD(Quaque Die) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 18 and 50 years at screening;
- Subjects with a Body Mass Index (BMI) between 18.0 (inclusive) and 28.0 kg/m2 (inclusive); and a total body weight ≥55kg (male） and 45kg (female)
- Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
- Subject is willing to participate and to Sign written informed consent form.
Key exclusion criteria (9 listed)
- Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
- Subjects with evidence or a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except simple appendectomy or repair of hernia) that may influence drug absorption
- Subjects with evidence or a history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (mood disorder, obsessive-compulsive disorder, etc.) diseases.
- Subjects with a history or current have mental disease.
- Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
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 |
|---|---|---|
| dose-5 groupIBI128 300mg po. QD(Quaque Die) | Drug | IBI128 |
| dose-1 groupIBI128 25mg po. QD(Quaque Die) | Drug | IBI128 |
| dose-2 groupIBI128 50mg po. QD(Quaque Die) | Drug | IBI128 |
| dose-4 groupIBI128 200mg po. QD(Quaque Die) | Drug | IBI128 |
| dose-3 groupIBI128 100mg po. QD(Quaque Die) | Drug | IBI128 |
Primary outcome
PK parameter: Cmax
Time frame: Up to Day 8
Maximum plasma concentration(Cmax) of IBI128
PK parameter: AUC
Time frame: Up to Day 8
Area under the concentration-time curve （AUC）of IBI128
PK parameter: Tmax
Time frame: Up to Day 8
Time to ahieve Cmax
PK parameter: T1/2
Time frame: Up to Day 8
The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.
3 secondary outcomes
Safety parameter: AE
Time frame: Up to Day 8
PD parameter: serum UA (uric acid）
Time frame: Up to Day 8
Tolerability parameter: SAE
Time frame: Up to Day 8
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 22 Mar 2024.
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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.
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 dose-5 group, dose-1 group and dose-2 group in people with Gout Arthritis, run by Innovent Biologics (Suzhou) 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 4 inclusion and 9 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 22 Mar 2024. 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. 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?
PK parameter: Cmax (time frame: Up to Day 8). The study lists 4 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 22 Mar 2024.