Rheumatoid ArthritisPhase 1NCT07040930
Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.
A Phase 1 study testing GenSci120 in people with Rheumatoid Arthritis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GenSci120
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 20 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-55; ≥3 per gender for each cohort.
- BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
- No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
- Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH >40 IU/L).
- Able to provide informed consent; willing to comply with all study requirements
Who cannot join
- Allergy to GenSci120 or severe allergies.
- Injection site issues affecting evaluation.
- Significant medical conditions impacting study outcome.
- History of malignant tumors, including listed cancers.
- Seizure history, head injury causing unconsciousness.
- Psychiatric disorders impairing daily activities or cognitive issues.
Show all 23Show fewer
- Severe immunodeficiency (e.g., HIV).
- Recent trauma, surgery, or GI issues affecting absorption.
- Recent severe infections or antimicrobial treatments.
- Live vaccines within a month prior to screening.
- Abnormal vital signs/ECG: BP extremes, QTcF >450ms.
- Positive for hepatitis B/C, HIV, syphilis during screening.
- Positive TB test via IGRA.
- Recent use of immunosuppressive or targeted therapies.
- Medication use within 14 days prior to randomization.
- Participation in other clinical trials recently/currently.
- Excessive alcohol consumption (over six months).
- Heavy smoking, unwillingness to quit, positive nicotine tests.
- Positive drug screen for specific substances.
- Recent soft/hard drug use within specified periods.
- Blood donation/product receipt recently or poor venous access.
- Study staff involved in the trial.
- Other conditions deemed unsuitable by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Wei Liu, 021-52887926, 383618205@qq.com
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China
This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.
- Conditions
- Rheumatoid Arthritis
- Being tested
- GenSci120, Placebo
- Keywords
- phase Ib, healthy adult, multiple subcutaneous injections, GenSci120
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci120Drug
a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
PlaceboDrug
a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level
| Study group | Role | What they receive |
|---|---|---|
| GenSci120 | Experimental | Multiple ascending doses of GenSci120 administered subcutaneously (SC). Receives: Drug: GenSci120 |
| Placebo | Experimental | Multiple ascending doses of placebo administered subcutaneously (SC). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAEs
Incidence and severity of treatment-emergent adverse events
Measured: 169 days
SAEs
Incidence and severity of serious adverse events
Measured: 169 days
CSfadf
Clinically significant changes from baseline
Measured: 169 days
Secondary outcomes (11)
plasma
Concentration of GenSci120 in plasma samples.
Measured: 169 days
AUC0-t, AUC0-∞
Area under drug concentration-time curve
Measured: 169 days
Tmax
time to maximum concentration
Measured: 169 days
Cmax
maximum concentration
Measured: 169 days
t1/2
169 days
Measured: half-life
CL/F
169 days
Measured: apparent clearance
V/F
apparent volume of distribution
Measured: 169 days
RO of T cell subset
Receptor occupancy (RO) of T cell subset detected by flow cytometry
Measured: 169 days
cell counts of T cell subset
cell counts of T cell subset detected by flow cytometry
Measured: 169 days
Incidence of ADA
Incidence of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration
Measured: 169 days
Time of ADA
Time of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration
Measured: 169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Aug 2025
- Primary completion5 Jul 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, M.D., Principal investigator, Huashan HospitalXiaojie Wu, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040930
- Sponsor's protocol ID
- GenSci120-103
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 6 Aug 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China
- ClinicalTrials.gov ID
- NCT07040930
- Acronym / sponsor ID
- GenSci120-103
- Conditions
- Rheumatoid Arthritis
- Keywords
- phase Ib, healthy adult, multiple subcutaneous injections, GenSci120
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.
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 |
|---|---|---|
| GenSci120 | Experimental | Drug: GenSci120Multiple ascending doses of GenSci120 administered subcutaneously (SC). |
| Placebo | Experimental | Drug: PlaceboMultiple ascending doses of placebo administered subcutaneously (SC). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18-55; ≥3 per gender for each cohort.
- BMI: 18-30; Weight: ≥50 kg (male), ≥45 kg (female).
- No clinically significant abnormalities in medical history, physical exam, vital signs, or lab/ECG/pulmonary imaging.
- Men/WOCBP must use effective contraception throughout study; no plans to conceive; WOCBP must have negative pregnancy test and not breastfeeding. Women of non-childbearing potential: post-hysterectomy/salpingectomy or postmenopausal (FSH >40 IU/L).
- Able to provide informed consent; willing to comply with all study requirements
Key exclusion criteria (23 listed)
- Allergy to GenSci120 or severe allergies.
- Injection site issues affecting evaluation.
- Significant medical conditions impacting study outcome.
- History of malignant tumors, including listed cancers.
- Seizure history, head injury causing unconsciousness.
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 |
|---|---|---|
| GenSci120a total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level | Drug | GenSci120 |
| Placeboa total of 3 doses of the investigational medicinal product (IMP) SC every four weeks (Q4W) at the planned dose level | Drug | Placebo |
Primary outcome
TEAEs
Time frame: 169 days
Incidence and severity of treatment-emergent adverse events
SAEs
Time frame: 169 days
Incidence and severity of serious adverse events
CSfadf
Time frame: 169 days
Clinically significant changes from baseline
11 secondary outcomes
plasma
Time frame: 169 days
AUC0-t, AUC0-∞
Time frame: 169 days
Tmax
Time frame: 169 days
Cmax
Time frame: 169 days
t1/2
Time frame: half-life
CL/F
Time frame: apparent clearance
V/F
Time frame: 169 days
RO of T cell subset
Time frame: 169 days
cell counts of T cell subset
Time frame: 169 days
Incidence of ADA
Time frame: 169 days
Time of ADA
Time frame: 169 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Jing Zhang, M.D. principal investigator
Huashan Hospital
Xiaojie Wu, M.D. principal investigator
Huashan 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 GenSci120 in people with Rheumatoid Arthritis, 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 5 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 6 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiting Chi, Master (+86 13482779422, chiyiting@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAEs (time frame: 169 days). The study lists 3 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 6 Aug 2025.