Cutaneous Lupus Erythematosus(CLE)Phase 1NCT07749651
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
A Phase 1 study of Cutaneous Lupus Erythematosus(CLE), run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Lupus Erythematosus(CLE)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2026to Aug 2027
- 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
- The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.
- Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value)
- Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods
- Female participants: not pregnant or lactatin
- Before the trial, the participants had understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial in detail, were able to understand the procedures and methods of the study, were willing to strictly abide by the requirements of the entire clinical study, and voluntarily signed informed consent
Who cannot join
- Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment
- Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection
- Patients with chronic or recurrent infection requiring treatment within 12 months before screening
- A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive
- There was a previous history of risk factors for torsades de pointes
- Patients who had undergone major surgery within 6 months before screening
Show all 15Show fewer
- Persons who had been vaccinated within 1 month before screening or planned to be vaccinated during the trial
- Anyone who had taken any medication or health product (including Chinese herbal medicine) within 7 half-lives or 14 days before dose, whichever was longer, or who had known during the screening period that they might need to receive additional medication during the trial
- Participants who had participated in a clinical trial and received a trial drug within 3 months before screening or who planned to participate in another clinical trial during the trial
- Patients were screened if they had donated or lost at least 400 mL of blood (except physiological blood loss in women) within 3 months before the trial, received a transfusion or used blood products, or were planning to donate blood during or within 1 month after the trial
- People who have special dietary requirements and cannot follow a uniform diet
- Those with a history of drug abuse, drug use, or a positive screening test for drug abuse
- Those who have difficulty in venous blood collection/cannot tolerate venipuncture, or have a history of fainting or fainting
- If the site of administration was abnormal, the investigator judged that subcutaneous administration was not suitable
- Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment
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
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 314408
Yiwen Zhang
Ping Huang
About this study
A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
- Conditions
- Cutaneous Lupus Erythematosus(CLE)
- Being tested
- SHR-7012 injection ; placebo, SHR-7012 injection ; placebo ;
- Medical subject headings
- Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-7012 injection ; placeboDrug
A single subcutaneous injection of Dose1 SHR-7012 injection or placebo was administered
SHR-7012 injection ; placeboDrug
A single subcutaneous injection of Dose2 SHR-7012 injection or placebo was administered
SHR-7012 injection ; placeboDrug
A single subcutaneous injection of Dose3 SHR-7012 injection or placebo was administered
SHR-7012 injection ; placeboDrug
A single subcutaneous injection of Dose4 SHR-7012 injection or placebo was administered
SHR-7012 injection ; placebo ;Drug
A single subcutaneous injection of Dose5 SHR-7012 injection or placebo was administered
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: Dose1 Injection of SHR-7012 or placebo | Experimental | Not described Receives: Drug: SHR-7012 injection ; placebo |
| Treatment group 2: Dose2 Injection of SHR-7012 or placebo | Experimental | Not described Receives: Drug: SHR-7012 injection ; placebo |
| Treatment group 3: Dose3 Injection of SHR-7012 or placebo | Experimental | Not described Receives: Drug: SHR-7012 injection ; placebo |
| Treatment group 4: Dose4 Injection of SHR-7012 or placebo | Experimental | Not described Receives: Drug: SHR-7012 injection ; placebo |
| Treatment group 5: Dose5 Injection of SHR-7012 or placebo | Experimental | Not described Receives: Drug: SHR-7012 injection ; placebo ; |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability : Incidence and severity of any adverse events
Measured: Evaluation was performed up to Day141
Secondary outcomes (13)
AUC0-t
Measured: Evaluation was performed up to Day113 or Day141
AUC0 ∞
Measured: Evaluation was performed up to Day113 or Day141
Tmax
Measured: Evaluation was performed up to Day113 or Day141
Cmax
Measured: Evaluation was performed up to Day113 or Day141
t1/2
Measured: Evaluation was performed up to Day113 or Day141
λz
Measured: Evaluation was performed up to Day113 or Day141
CL/F
Measured: Evaluation was performed up to Day113 or Day141.
Vz/F
Measured: Evaluation was performed up to Day113 or Day141.
MRT0-t
Measured: Evaluation was performed up to Day113 or Day141.
MRT0-∞
Measured: Evaluation was performed up to Day113 or Day141.
AUC%Extrap
Measured: Evaluation was performed up to Day113 or Day141.
Antidrug antibody (ADA)
Measured: Evaluation was performed up to Day113 or Day141.
Neutralizing antibody (NAb)
Measured: Evaluation was performed up to Day113 or Day141.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start19 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus Erythematosus(CLE)Studies 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
- 50 participants (estimated)
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
- NCT07749651
- Sponsor's protocol ID
- SHR-7012-101
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 31 Aug 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07749651
- Acronym / sponsor ID
- SHR-7012-101
- Conditions
- Cutaneous Lupus Erythematosus(CLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Aug 2026 (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 Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SHR-7012 in Healthy Adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1: Dose1 Injection of SHR-7012 or placebo | Experimental | Drug: SHR-7012 injection ; placebo |
| Treatment group 2: Dose2 Injection of SHR-7012 or placebo | Experimental | Drug: SHR-7012 injection ; placebo |
| Treatment group 3: Dose3 Injection of SHR-7012 or placebo | Experimental | Drug: SHR-7012 injection ; placebo |
| Treatment group 4: Dose4 Injection of SHR-7012 or placebo | Experimental | Drug: SHR-7012 injection ; placebo |
| Treatment group 5: Dose5 Injection of SHR-7012 or placebo | Experimental | Drug: SHR-7012 injection ; placebo ; |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female.
- Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value)
- Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods
- Female participants: not pregnant or lactatin
- Before the trial, the participants had understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial in detail, were able to understand the procedures and methods of the study, were willing to strictly abide by the requirements of the entire clinical study, and voluntarily signed informed consent
Key exclusion criteria (15 listed)
- Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment
- Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection
- Patients with chronic or recurrent infection requiring treatment within 12 months before screening
- A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive
- There was a previous history of risk factors for torsades de pointes
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-7012 injection ; placeboA single subcutaneous injection of Dose1 SHR-7012 injection or placebo was administered | Drug | Treatment group 1: Dose1 Injection of SHR-7012 or placebo |
| SHR-7012 injection ; placeboA single subcutaneous injection of Dose2 SHR-7012 injection or placebo was administered | Drug | Treatment group 2: Dose2 Injection of SHR-7012 or placebo |
| SHR-7012 injection ; placeboA single subcutaneous injection of Dose3 SHR-7012 injection or placebo was administered | Drug | Treatment group 3: Dose3 Injection of SHR-7012 or placebo |
| SHR-7012 injection ; placeboA single subcutaneous injection of Dose4 SHR-7012 injection or placebo was administered | Drug | Treatment group 4: Dose4 Injection of SHR-7012 or placebo |
| SHR-7012 injection ; placebo ;A single subcutaneous injection of Dose5 SHR-7012 injection or placebo was administered | Drug | Treatment group 5: Dose5 Injection of SHR-7012 or placebo |
Primary outcome
Safety and tolerability : Incidence and severity of any adverse events
Time frame: Evaluation was performed up to Day141
13 secondary outcomes
AUC0-t
Time frame: Evaluation was performed up to Day113 or Day141
AUC0 ∞
Time frame: Evaluation was performed up to Day113 or Day141
Tmax
Time frame: Evaluation was performed up to Day113 or Day141
Cmax
Time frame: Evaluation was performed up to Day113 or Day141
t1/2
Time frame: Evaluation was performed up to Day113 or Day141
λz
Time frame: Evaluation was performed up to Day113 or Day141
CL/F
Time frame: Evaluation was performed up to Day113 or Day141.
Vz/F
Time frame: Evaluation was performed up to Day113 or Day141.
MRT0-t
Time frame: Evaluation was performed up to Day113 or Day141.
MRT0-∞
Time frame: Evaluation was performed up to Day113 or Day141.
AUC%Extrap
Time frame: Evaluation was performed up to Day113 or Day141.
Antidrug antibody (ADA)
Time frame: Evaluation was performed up to Day113 or Day141.
Neutralizing antibody (NAb)
Time frame: Evaluation was performed up to Day113 or Day141.
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 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cutaneous Lupus Erythematosus(CLE)
Not yet recruitingPhase 2
This Study Will Evaluate the Effect and Safety of 626 in Patients With CLE
Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
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.
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 of Cutaneous Lupus Erythematosus(CLE), 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 15 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 31 Aug 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. 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 Yuqing Huang (+0518-82342973, yuqing.huang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability : Incidence and severity of any adverse events (time frame: Evaluation was performed up to Day141). 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 31 Aug 2026.