Rheumatoid ArthritisPhase 1NCT06883695
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
A Phase 1 study testing SHR-3045 Injection in people with Rheumatoid Arthritis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects. 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?
- SHR-3045 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 10 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
- Subjects who can provide written informed consent.
- Males or females aged 18-55 years (both inclusive).
- Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.
- No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
Who cannot join
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
- Known or suspected history of drug abuse.
- Addiction to tobacco and alcohol.
- Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
- Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SHR-3045 Injection, SHR-3045 Placebo Injection
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-3045 InjectionDrug
SHR-3045 injection.
SHR-3045 Placebo InjectionDrug
SHR-3045 placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3045 Group | Experimental | Not described Receives: Drug: SHR-3045 Injection |
| SHR-3045 Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-3045 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: From screening period up to day 113.
Secondary outcomes (6)
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
Measured: Post-dose at day 1 to day 113.
Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).
Measured: Post-dose at day 1 to day 113.
Maximum observed concentration of SHR-3045 (Cmax).
Measured: Post-dose at day 1 to day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).
Measured: Post-dose at day 1 to day 113.
Clearance of SHR-3045 (CL).
Measured: Post-dose at day 1 to day 113.
Terminal elimination half-life of SHR-3045 (t1/2).
Measured: Post-dose at day 1 to day 113.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start8 Apr 2025
- Primary completion17 Jun 2025
- Study completion10 Oct 2025
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 Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883695
- Sponsor's protocol ID
- SHR-3045-101
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06883695
- Acronym / sponsor ID
- SHR-3045-101
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 19 Mar 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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 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 |
|---|---|---|
| SHR-3045 Group | Experimental | Drug: SHR-3045 Injection |
| SHR-3045 Placebo Group | Placebo comparator | Drug: SHR-3045 Placebo Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects with ability to understand the trial procedures and possible adverse events, voluntary participation in the trial.
- Subjects who can provide written informed consent.
- Males or females aged 18-55 years (both inclusive).
- Males with body weight ≥ 50 kg, or females with body weight ≥ 45 kg.
- No clinically significant abnormalities in the medical history, general physical examinations, vital signs and laboratory tests.
Key exclusion criteria (5 listed)
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening.
- Known or suspected history of drug abuse.
- Addiction to tobacco and alcohol.
- Individuals who are unable to adhere to the dietary requirements of this trial during the study period.
- Judged by the investigator, there are any other conditions that interfere with the results evaluation of the trial.
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 |
|---|---|---|
| SHR-3045 InjectionSHR-3045 injection. | Drug | SHR-3045 Group |
| SHR-3045 Placebo InjectionSHR-3045 placebo injection. | Drug | SHR-3045 Placebo Group |
Primary outcome
Adverse events (AEs)
Time frame: From screening period up to day 113.
6 secondary outcomes
Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last).
Time frame: Post-dose at day 1 to day 113.
Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf).
Time frame: Post-dose at day 1 to day 113.
Maximum observed concentration of SHR-3045 (Cmax).
Time frame: Post-dose at day 1 to day 113.
Time to maximum observed concentration of SHR-3045 (Tmax).
Time frame: Post-dose at day 1 to day 113.
Clearance of SHR-3045 (CL).
Time frame: Post-dose at day 1 to day 113.
Terminal elimination half-life of SHR-3045 (t1/2).
Time frame: Post-dose at day 1 to day 113.
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 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 SHR-3045 Injection in people with Rheumatoid Arthritis, run by Guangdong Hengrui 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 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 5 Jun 2026. 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?
Adverse events (AEs) (time frame: From screening period up to day 113.). 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 5 Jun 2026.