Gouty Arthritis (GA)Phase 1NCT06451848
A Bioequivalence Study of Two Different Dosage Form of Genakumab
A Phase 1 study testing Genakumab Injection (T, Solution for injection) and Genakumab for Injection (R, Powder for solution for injection) in people with Gouty Arthritis (GA), run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gouty Arthritis (GA)
- What is being tested?
- Genakumab Injection (T, Solution for injection) and Genakumab for Injection (R, Powder for solution for injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2024to 10 Jan 2025
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged ≥18 years old and≤45 years old;
- The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
- Subjects who voluntarily signed the informed consent form (ICF)；
- Subjects of childbearing potential had no plans for pregnancy or donating sperm/ova and agreed to use reliable contraception during the study and for 3 months after the last dose;
Who cannot join
- (During screening) Allergic to the investigational product, any of its components, or any biological agents, or had a history of multiple allergies (two or more) to drugs, foods, or environmental factors, or were prone to allergic symptoms such as rashes or urticaria;
- (During screening inquiry) Previously unable to tolerate intravenous puncture/indwelling needles for blood collection, or had a history of hemophobia or fear of needles;
- Abnormal vital signs (pulse < 50 bpm or > 100 bpm when awake, systolic blood pressure ≥ 140 mmHg or < 90 mmHg or diastolic blood pressure ≥ 90 mmHg or < 60 mmHg, forehead temperature > 37.3°C); ECG QTc-F interval ≥ 460 ms, or other clinically significant ECG abnormalities; abnormal findings in physical examination, laboratory tests, chest CT, and abdominal B-mode ultrasound;
- Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA)；
- (During screening/admission inquiry) Had a clear history of neurological or psychiatric disorders (including epilepsy, dementia, depression, bipolar affective disorder, schizophrenia, etc.); history of prolonged QTc interval; immunodeficiency or immunosuppressive diseases, malignant tumors; clinically significant chronic diseases related to cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive systems;
- Underwent major surgery (such as coronary artery bypass graft, liver or kidney resection, gynecological surgeries, etc.) within 6 months prior to the first dose; experienced acute neurological, digestive, respiratory, circulatory, endocrine, or hematological diseases within 3 months prior to screening that could affect the absorption, distribution, metabolism, excretion, and safety evaluation of the investigational product;
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- History of drug abuse within 1 year prior to the first dose, or tested positive in a multi-drug urine test at admission；
- Smoked more than 5 cigarettes per day on average in the 3 months prior to screening or unable to cease use of any tobacco products (including nicotine products) during the study;
- Alcoholic or drank more than 14 units of alcohol per week in the 4 weeks prior to screening (1 unit equals 17.5 mL or 14g of pure alcohol. The alcohol content of different types of alcoholic beverages is indicated by volume percentage. One alcohol unit is approximately equivalent to 35 mL of 50% alcohol by volume [ABV] Baijiu or 350 mL of 5% ABV beer), unwilling to abstain from drinking alcohol or consuming any alcohol-containing products during the study, or tested positive for alcohol at admission;
- Received treatment with the investigational product or medical device in any clinical trial within 3 months prior to the first dose;
- Regularly used any prescription or over-the-counter (OTC) drugs, biologics, Chinese patent drugs, herbal supplements, vitamins, dietary supplements, or maintenance products within 2 weeks prior to the first dose, except for oral or implanted long-acting contraceptives;
- The investigator assessed that there were other factors making the subject unsuitable for participation in the study.etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-blind, Single Dose Bioequivalence Trial of Genakumab in Chinese Healthy Male Adults
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
- Conditions
- Gouty Arthritis (GA)
- Being tested
- Genakumab Injection (T, Solution for injection), Genakumab for Injection (R, Powder for solution for injection)
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genakumab Injection (T, Solution for injection)Drug
A single dose of subcutaneous injection of Genakumab（Solution for injection, liquid formulation）200 mg on Day 1
Genakumab for Injection (R, Powder for solution for injection)Drug
A single dose of subcutaneous injection of Genakumab（Powder for solution for injection, lyophilized formulation) 200 mg on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Test preparation（T） | Experimental | Genakumab Solution for Injection (T, liquid formulation) Receives: Drug: Genakumab Injection (T, Solution for injection); Drug: Genakumab for Injection (R, Powder for solution for injection) |
| Reference preparation（R） | Experimental | Genakumab Powder for solution for Injection (R, lyophilized formulation) Receives: Drug: Genakumab Injection (T, Solution for injection); Drug: Genakumab for Injection (R, Powder for solution for injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Area under the concentration-time curve (AUC), of Genakumab Injection with Genakumab for Injection
Measured: 0 hours -3360 hours post-administration
Pharmacokinetics (Peak Plasma Concentration (Cmax)）of Genakumab Injection with Genakumab for Injection
Measured: 0 hours -3360 hours post-administration
Pharmacokinetics (Peak time (Tmax) of Genakumab Injection with Genakumab for Injection
Measured: 0 hours -3360 hours post-administration
Pharmacokinetics (The elimination half-life (T1/2) of Genakumab Injection with Genakumab for Injection
Measured: 0 hours -3360 hours post-administration
Secondary outcomes (1)
Safety and tolerability（Number of participants with treatment-related adverse events）
Measured: up to approximately 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start24 Jun 2024
- Primary completion29 Nov 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gouty Arthritis (GA)Studies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451848
- Sponsor's protocol ID
- GenSci048-104
- Status last verified
- Nov 2024
- First submitted
- 28 May 2024
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Single Dose Bioequivalence Trial of Genakumab in Chinese Healthy Male Adults
- ClinicalTrials.gov ID
- NCT06451848
- Acronym / sponsor ID
- GenSci048-104
- Conditions
- Gouty Arthritis (GA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 11 Jun 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.
The purpose of this study is to investigate whether Genakumab Injection is bioequivalent to Genakumab for Injection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test preparation（T） | Experimental | Drug: Genakumab Injection (T, Solution for injection), Drug: Genakumab for Injection (R, Powder for solution for injection)Genakumab Solution for Injection (T, liquid formulation) |
| Reference preparation（R） | Experimental | Drug: Genakumab Injection (T, Solution for injection), Drug: Genakumab for Injection (R, Powder for solution for injection)Genakumab Powder for solution for Injection (R, lyophilized formulation) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male aged ≥18 years old and≤45 years old;
- The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
- Subjects who voluntarily signed the informed consent form (ICF)；
- Subjects of childbearing potential had no plans for pregnancy or donating sperm/ova and agreed to use reliable contraception during the study and for 3 months after the last dose;
Key exclusion criteria (12 listed)
- (During screening) Allergic to the investigational product, any of its components, or any biological agents, or had a history of multiple allergies (two or more) to drugs, foods, or environmental factors, or were prone to allergic symptoms such as rashes or urticaria;
- (During screening inquiry) Previously unable to tolerate intravenous puncture/indwelling needles for blood collection, or had a history of hemophobia or fear of needles;
- Abnormal vital signs (pulse < 50 bpm or > 100 bpm when awake, systolic blood pressure ≥ 140 mmHg or < 90 mmHg or diastolic blood pressure ≥ 90 mmHg or < 60 mmHg, forehead temperature > 37.3°C); ECG QTc-F interval ≥ 460 ms, or other clinically significant ECG abnormalities; abnormal findings in physical examination, laboratory tests, chest CT, and abdominal B-mode ultrasound;
- Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA)；
- (During screening/admission inquiry) Had a clear history of neurological or psychiatric disorders (including epilepsy, dementia, depression, bipolar affective disorder, schizophrenia, etc.); history of prolonged QTc interval; immunodeficiency or immunosuppressive diseases, malignant tumors; clinically significant chronic diseases related to cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive systems;
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 |
|---|---|---|
| Genakumab Injection (T, Solution for injection)A single dose of subcutaneous injection of Genakumab（Solution for injection, liquid formulation）200 mg on Day 1 | Drug | Reference preparation（R）, Test preparation（T） |
| Genakumab for Injection (R, Powder for solution for injection)A single dose of subcutaneous injection of Genakumab（Powder for solution for injection, lyophilized formulation) 200 mg on Day 1 | Drug | Reference preparation（R）, Test preparation（T） |
Primary outcome
Pharmacokinetics (Area under the concentration-time curve (AUC), of Genakumab Injection with Genakumab for Injection
Time frame: 0 hours -3360 hours post-administration
Pharmacokinetics (Peak Plasma Concentration (Cmax)）of Genakumab Injection with Genakumab for Injection
Time frame: 0 hours -3360 hours post-administration
Pharmacokinetics (Peak time (Tmax) of Genakumab Injection with Genakumab for Injection
Time frame: 0 hours -3360 hours post-administration
Pharmacokinetics (The elimination half-life (T1/2) of Genakumab Injection with Genakumab for Injection
Time frame: 0 hours -3360 hours post-administration
1 secondary outcome
Safety and tolerability（Number of participants with treatment-related adverse events）
Time frame: up to approximately 85 days
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 11 Feb 2025.
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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 Genakumab Injection (T, Solution for injection) and Genakumab for Injection (R, Powder for solution for injection) in people with Gouty Arthritis (GA), run by Changchun GeneScience Pharmaceutical 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 12 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 11 Feb 2025. 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?
Pharmacokinetics (Area under the concentration-time curve (AUC), of Genakumab Injection with Genakumab for Injection (time frame: 0 hours -3360 hours post-administration). 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 11 Feb 2025.