Arthritis, GoutyPhase 1NCT05966701
The MAD Study of SSGJ-613 in Healthy Subjects
A Phase 1 study testing SSGJ-613 in people with Arthritis, Gouty, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Gouty
- What is being tested?
- SSGJ-613
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 10 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
- The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
Who cannot join
- Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
- Subjects who have or are currently suffering from any serious clinical diseases before screening,
- Abnormal vital signs or abnormal ECGor physical examination are clinically significant
- Clinical laboratory examinations found to be abnormal and have clinical significance
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
- Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
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- Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening
- Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration
- Has known or suspected pregnancy or lactation
- Subjects who are unsuited to the study for any reason, judged by the investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200031
Qian Chen, PhD, 021-54030254, qchen@shxh-centerlab.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalation Phase I Clinical Study of Humanized Monoclonal Antibody Injection (SSGJ-613) in Healthy Adult Chinese Subjects
To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
Read the detailed description
The purposes of this study are to evaluate the safety and tolerability, PK characteristics and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
- Conditions
- Arthritis, Gouty
- Being tested
- SSGJ-613, Placebo
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSGJ-613Drug
SSGJ-613 subcutaneous injection.
PlaceboDrug
Placebo subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| SSGJ-613 | Experimental | SSGJ-613，SC Receives: Drug: SSGJ-613 |
| Placebo | Placebo comparator | Placebo, SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc..
Measured: Up to Day 174
Secondary outcomes (1)
SSGJ-613 Concentration in Serum
The concentration of SSGJ-613 in Serum.
Measured: Up to Day 174
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start10 Aug 2023 (estimated)
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, GoutyStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qinghong Zhou, BS, Study director, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Qian Chen, PhD, Principal investigator, Shanghai Xuhui District Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966701
- Sponsor's protocol ID
- SSGJ-613-HH-I-02
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalation Phase I Clinical Study of Humanized Monoclonal Antibody Injection (SSGJ-613) in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT05966701
- Acronym / sponsor ID
- SSGJ-613-HH-I-02
- Conditions
- Arthritis, Gouty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 1 Aug 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.
To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
Detailed description
The purposes of this study are to evaluate the safety and tolerability, PK characteristics and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSGJ-613 | Experimental | Drug: SSGJ-613SSGJ-613，SC |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, SC |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
- The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
- Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
Key exclusion criteria (10 listed)
- Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
- Subjects who have or are currently suffering from any serious clinical diseases before screening,
- Abnormal vital signs or abnormal ECGor physical examination are clinically significant
- Clinical laboratory examinations found to be abnormal and have clinical significance
- Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
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 |
|---|---|---|
| SSGJ-613SSGJ-613 subcutaneous injection. | Drug | SSGJ-613 |
| PlaceboPlacebo subcutaneous injection. | Drug | Placebo |
Primary outcome
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
Time frame: Up to Day 174
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc..
1 secondary outcome
SSGJ-613 Concentration in Serum
Time frame: Up to Day 174
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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.
Qinghong Zhou, BS study director
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Qian Chen, PhD 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 SSGJ-613 in people with Arthritis, Gouty, run by Sunshine Guojian Pharmaceutical (Shanghai) 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 10 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qinghong Zhou, BS (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. (time frame: Up to Day 174). 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 1 Aug 2023.