Systemic Lupus ErythematosusPhase 1NCT07751315

A Study of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases

A Phase 1 study testing Ia:QLS2404 very low dose, Ia:QLS2404 low dose and Ia:QLS2404 middle dose in people with Systemic Lupus Erythematosus and Primary Sjögren's Syndrome, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
What is being tested?: Ia:QLS2404 very low dose, Ia:QLS2404 low dose and Ia:QLS2404 middle dose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteChina
Study dates: 11 Aug 2026to 30 Jun 2028
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ia
Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements.
Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form.
Body mass index (BMI) at screening ≥19 kg/m² and ≤26 kg/m², with body weight ≥45 kg.
Participants assessed by the investigator to be in good health based on medical history, physical examination, vital signs, and laboratory test results during the screening period.
Ib

Show all 12Show fewer

Participants who voluntarily sign the informed consent form before the initiation of any study-related procedures, are able to communicate effectively with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol, and complete the study.
Male or female participants aged ≥18 and ≤65 years at the time of signing the informed consent form.
Body mass index (BMI) at screening ≥18 kg/m² and ≤35 kg/m².
Participants with systemic lupus erythematosus must meet the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE and be diagnosed with systemic lupus erythematosus; the diagnosis must have been established at least 6 months prior to signing the informed consent form.
Participants with primary Sjögren's syndrome must meet the 2016 ACR/EULAR classification criteria for primary Sjögren's syndrome and be diagnosed with primary Sjögren's syndrome; the diagnosis must have been established at least
months prior to signing the informed consent form.

Who cannot join

Ia
QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant.
Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial.
Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening.
Participants who are considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete this study for other reasons.
Ib

Show all 11Show fewer

Any disease or condition that, in the investigator's opinion, may interfere with the evaluation of study drug efficacy, participant safety assessment, or interpretation of study results.
Participants who have participated in any cell therapy, gene therapy clinical trial, or medical device clinical trial within 3 months prior to screening.
Participants who have received Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
Participants who have received any live attenuated vaccine within 1 month prior to screening or who require live attenuated vaccination during study participation.
Participants who are breastfeeding or have a positive serum human chorionic gonadotropin (hCG) test during the screening period.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ping Feng, phD contact

028-85422707

617130961@qq.com

Qibing Xie, phD contact

028-85422707

xqb_fsmygcp@126.com

China1 site

West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Ping Feng, phD, 028-85422707, 617130961@qq.com
Qibing Xie, phD, 028-85422707, xqb_fsmygcp@126.com

Other trials in China

About this study

Official title: A Phase Ia/Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases

This study consists of a randomized, double-blind, placebo-controlled Phase Ia part and an open-label Phase Ib part. The Phase Ia part is a single ascending-dose study of subcutaneous QLS2404 Injection in healthy participants, designed to evaluate the safety and tolerability of QLS2404 Injection in healthy participants. The Phase Ib part is a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus and primary Sjögren's syndrome, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection.

Read the detailed description

The Phase Ia single-dose ascending stage will include five dose groups. The study plans to enroll 40 adult healthy participants, with 8 participants in each dose group, who will be randomized in a 3:1 ratio to receive QLS2404 Injection or placebo. Dose escalation will be conducted sequentially from the initial dose to higher dose levels in accordance with the dose-escalation principle.

During the study, a Safety Monitoring Committee (SMC), composed of the investigators, the sponsor, or sponsor-designated personnel, will review the safety data generated during the trial. After the last participant in each dose group has completed the 14-day tolerability observation period following dosing, the SMC will review the safety data of participants in each cohort and conduct an integrated assessment of the available pharmacokinetic (PK) and pharmacodynamic (PD) data. The SMC will then provide recommendations regarding dose escalation or, if necessary, adjustments to the dose-escalation scheme.

The Phase Ib part will be a multiple ascending-dose study of subcutaneous QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS), designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of QLS2404 Injection. Three dose groups are planned, with approximately 24 participants to be enrolled in total and 8 participants in each dose group. All participants will receive three subcutaneous doses of QLS2404 Injection, administered at 4-week intervals. Each dose group must include at least 6 participants with SLE, and the study will be conducted in strict accordance with the dose-escalation principle.

Conditions: Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
Being tested: Ia:QLS2404 very low dose, Ia:QLS2404 low dose, Ia:QLS2404 middle dose, Ia:QLS2404 high dose, Ia:QLS2404 Max dose
Keywords: systemic lupus erythematosus, primary Sjögren's syndrome, SLE, pSS
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ia:QLS2404 very low doseDrug
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 low doseDrug
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 middle doseDrug
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 high doseDrug
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ia:QLS2404 Max doseDrug
a single subcutaneous dose of QLS2404 Injection in healthy participants
Ib:QLS2404 low doseDrug
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Ib:QLS2404 middle doseDrug
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)
Ib:QLS2404 high doseDrug
multiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)

Study groups in NCT07751315
Study group	Role	What they receive
Ia treatment group 1	Experimental	Not described Receives: Drug: Ia:QLS2404 very low dose
Ia treatment group 2	Experimental	Not described Receives: Drug: Ia:QLS2404 low dose
Ia treatment group 3	Experimental	Not described Receives: Drug: Ia:QLS2404 middle dose
Ia treatment group 4	Experimental	Not described Receives: Drug: Ia:QLS2404 high dose
Ia treatment group 5	Experimental	Not described Receives: Drug: Ia:QLS2404 Max dose
Ib treatment group 1	Experimental	Not described Receives: Drug: Ib:QLS2404 low dose
Ib treatment group 2	Experimental	Not described Receives: Drug: Ib:QLS2404 middle dose
Ib treatment group 3	Experimental	Not described Receives: Drug: Ib:QLS2404 high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Ia:the safety and tolerability of a single subcutaneous dose of QLS2404 Injection in healthy participants
Number of participants with Adverse events and Serious adverse events
Measured: from the first single subcutaneous Inject of QLS2404 up to Day85
Ib:To evaluate the Adverse events of multiple subcutaneous injections of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS).
Number of participants with Adverse events and Serious adverse events
Measured: from the first single subcutaneous Inject of QLS2404 up to Day141.

Secondary outcomes (8)

Ia Outcome 1:To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
include serum QLS2404 concentrations such as peak plasma concentration (Cmax)
Measured: from the first single subcutaneous Inject of QLS2404 up to Day85
Ia Outcome 2:To evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
assessments include serum levels of IgM, IgG, and IgA at each scheduled time point before and after dosing
Measured: from the first single subcutaneous Inject of QLS2404 up to Day85.
Ia Outcome 3:To evaluate the immunogenicity of a single subcutaneous injection of QLS2404 Injection in healthy participants.
include the incidence and titers of anti-drug antibodies (ADAs) against QLS2404 Injection in healthy participants, and the incidence of neutralizing antibodies (NAbs), if data permit.
Measured: from the first single subcutaneous Inject of QLS2404 up to Day85
Ib Outcome 1:Applicable to participants with SLE: The proportion of participants with a ≥ 4-point decrease from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K).
SLEDAI-2K Description: The minimum SLEDAI-2K score is 0, and the maximum theoretical SLEDAI-2K score is 105. A score of 0 indicates no active disease; a greater score indicates higher systemic lupus erythematosus disease activity.
Measured: from the first subcutaneous Inject of QLS2404 up to Day141.
Ib Outcome 2:To evaluate the pharmacokinetic (PK) characteristics of multiple subcutaneous injections of QLS2404 Injection in participants .
Serum drug concentrations after administration peak plasma concentration (Cmax)
Measured: from the first subcutaneous Inject of QLS2404 up to Day141
Ib Outcome 3:Evaluate the PD characteristics of multiple subcutaneous injections of QLS2404 Injection in participants with SLE and pSS;
Serum IgM, IgG, and IgA levels at each assessment time point, and the percentage change from baseline;
Measured: from the first subcutaneous Inject of QLS2404 up to Day141
Ib Outcome 4:Evaluate the immunogenicity of multiple subcutaneous injections of QLS2404 Injection in participants with SLE and pSS;
Incidence and titers of anti-drug antibodies (ADA) to QLS2404 Injection in participants with SLE and pSS; incidence of neutralizing antibodies (NAb), if data permit.
Measured: from the first subcutaneous Inject of QLS2404 up to Day141
Applicable to participants with pSS: The proportion of participants with a ≥ 3-point ESSDAI
Description: The minimum ESSDAI score is 0, and the maximum ESSDAI score is 123. A score of 0 indicates no systemic disease activity; a greater score indicates higher systemic disease activity in Sjögren's syndrome.
Measured: from the first subcutaneous Inject of QLS2404 up to Day141.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 202630 Jun 2028

First posted7 Aug 2026
Study start11 Aug 2026 (estimated)
Primary completion7 Nov 2027 (estimated)
Study completion30 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by Qilu 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: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07751315
Sponsor's protocol ID: QLS2404-101
Status last verified: Jul 2026
First submitted: 23 Jul 2026
Last updated: 7 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Ping Feng, phD

028-85422707

617130961@qq.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
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

All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ia/Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of QLS2404 Injection in Healthy Participants and Participants With Rheumatic Autoimmune Diseases
ClinicalTrials.gov ID: NCT07751315
Acronym / sponsor ID: QLS2404-101
Conditions: Systemic Lupus Erythematosus, Primary Sjögren's Syndrome
Keywords: systemic lupus erythematosus, primary Sjögren's syndrome, SLE, pSS
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 64 participants (estimated)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 11 Aug 2026 (estimated)
Primary completion: 7 Nov 2027 (estimated)
Study completion: 30 Jun 2028 (estimated)
First posted: 7 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Ia treatment group 1	Experimental	Drug: Ia:QLS2404 very low dose
Ia treatment group 2	Experimental	Drug: Ia:QLS2404 low dose
Ia treatment group 3	Experimental	Drug: Ia:QLS2404 middle dose
Ia treatment group 4	Experimental	Drug: Ia:QLS2404 high dose
Ia treatment group 5	Experimental	Drug: Ia:QLS2404 Max dose
Ib treatment group 1	Experimental	Drug: Ib:QLS2404 low dose
Ib treatment group 2	Experimental	Drug: Ib:QLS2404 middle dose
Ib treatment group 3	Experimental	Drug: Ib:QLS2404 high dose

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Ia
Participants who understand and comply with the study procedures and methods, voluntarily participate in this trial, provide written informed consent, and are able to complete the study in accordance with the protocol requirements.
Male or female participants aged ≥18 and ≤45 years on the date of signing the informed consent form.
Body mass index (BMI) at screening ≥19 kg/m² and ≤26 kg/m², with body weight ≥45 kg.
Participants assessed by the investigator to be in good health based on medical history, physical examination, vital signs, and laboratory test results during the screening period.

Key exclusion criteria (11 listed)

Ia
QTcF interval corrected by electrocardiogram (ECG) ≥450 ms at screening; and any other ECG abnormalities that, in the investigator's opinion, may pose an unacceptable risk to the participant.
Participants with a history of, or current, chronic or serious diseases of the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, reproductive, or other systems, who are considered by the investigator to be unsuitable for participation in the clinical trial.
Participants who have lost more than 400 mL of blood due to blood donation or other reasons within 3 months prior to screening.
Participants who are considered by the investigator to be unsuitable for participation in the clinical trial or unable to complete this study for other reasons.

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
Ia:QLS2404 very low dosea single subcutaneous dose of QLS2404 Injection in healthy participants	Drug	Ia treatment group 1
Ia:QLS2404 low dosea single subcutaneous dose of QLS2404 Injection in healthy participants	Drug	Ia treatment group 2
Ia:QLS2404 middle dosea single subcutaneous dose of QLS2404 Injection in healthy participants	Drug	Ia treatment group 3
Ia:QLS2404 high dosea single subcutaneous dose of QLS2404 Injection in healthy participants	Drug	Ia treatment group 4
Ia:QLS2404 Max dosea single subcutaneous dose of QLS2404 Injection in healthy participants	Drug	Ia treatment group 5
Ib:QLS2404 low dosemultiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)	Drug	Ib treatment group 1
Ib:QLS2404 middle dosemultiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)	Drug	Ib treatment group 2
Ib:QLS2404 high dosemultiple subcutaneous doses of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS)	Drug	Ib treatment group 3

Primary outcome

Ia:the safety and tolerability of a single subcutaneous dose of QLS2404 Injection in healthy participants
Time frame: from the first single subcutaneous Inject of QLS2404 up to Day85
Number of participants with Adverse events and Serious adverse events
Ib:To evaluate the Adverse events of multiple subcutaneous injections of QLS2404 Injection in participants with systemic lupus erythematosus (SLE) and primary Sjögren's syndrome (pSS).
Time frame: from the first single subcutaneous Inject of QLS2404 up to Day141.
Number of participants with Adverse events and Serious adverse events

8 secondary outcomes

Ia Outcome 1:To evaluate the pharmacokinetic (PK) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
Time frame: from the first single subcutaneous Inject of QLS2404 up to Day85
Ia Outcome 2:To evaluate the pharmacodynamic (PD) characteristics of a single subcutaneous injection of QLS2404 Injection in healthy participants.
Time frame: from the first single subcutaneous Inject of QLS2404 up to Day85.
Ia Outcome 3:To evaluate the immunogenicity of a single subcutaneous injection of QLS2404 Injection in healthy participants.
Time frame: from the first single subcutaneous Inject of QLS2404 up to Day85
Ib Outcome 1:Applicable to participants with SLE: The proportion of participants with a ≥ 4-point decrease from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K).
Time frame: from the first subcutaneous Inject of QLS2404 up to Day141.
Ib Outcome 2:To evaluate the pharmacokinetic (PK) characteristics of multiple subcutaneous injections of QLS2404 Injection in participants .
Time frame: from the first subcutaneous Inject of QLS2404 up to Day141
Ib Outcome 3:Evaluate the PD characteristics of multiple subcutaneous injections of QLS2404 Injection in participants with SLE and pSS;
Time frame: from the first subcutaneous Inject of QLS2404 up to Day141
Ib Outcome 4:Evaluate the immunogenicity of multiple subcutaneous injections of QLS2404 Injection in participants with SLE and pSS;
Time frame: from the first subcutaneous Inject of QLS2404 up to Day141
Applicable to participants with pSS: The proportion of participants with a ≥ 3-point ESSDAI
Time frame: from the first subcutaneous Inject of QLS2404 up to 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 7 Aug 2026.

Related trials for Systemic Lupus Erythematosus

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
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
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

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.

Ping Feng, phD contact

028-85422707

617130961@qq.com

Qibing Xie, phD contact

028-85422707

xqb_fsmygcp@126.com

Ping Feng, phD principal investigator

West China Hospital

Qibing Xie, phD principal investigator

West China Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 11 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: opening soon, as of the sponsor's last update on 7 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 Ping Feng, phD (028-85422707, 617130961@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ia:the safety and tolerability of a single subcutaneous dose of QLS2404 Injection in healthy participants (time frame: from the first single subcutaneous Inject of QLS2404 up to Day85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07751315.

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 7 Aug 2026.