Healthy Participants StudyPhase 1NCT07861581
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection
A Phase 1 study testing QLS2312 Injection in people with Healthy Participants Study, run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
Trial summary
This study is a first-in-human Phase 1 clinical study conducted in healthy adult participants in China to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QLS2312 Injection after single and multiple subcutaneous administrations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- QLS2312 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2026to 20 Nov 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
- Understand and comply with the study procedures, voluntarily participate in this trial, and sign the informed consent form.
- Aged 18-55 years, inclusive.
- Body weight ≥50 kg for males and ≥45 kg for females; body mass index (BMI) 18.5-28.0 kg/m², inclusive.
- Serum IgA, IgG, and IgM are within the normal reference range.
- Medical history review, physical examination, laboratory tests, vital signs, imaging examinations, etc. are normal, or are judged by the investigator as abnormal but not clinically significant.
- From signing the informed consent form until the end of the trial or within 3 months after the last dose of the investigational product, whichever is longer: no plan to donate sperm or eggs, no plan for pregnancy, and willingness to use effective contraception.
Who cannot join
- History of definite food or drug allergy, or known allergy to the investigational product or its excipients.
- Prior use of any biologic targeting APRIL or MASP-2.
- Use of any prescription or non-prescription drug within 14 days before Screening, or still within 5 half-lives of the drug before Screening, whichever is longer.
- Use of other therapeutic biologics within 1 month before Screening; or still within 5 half-lives of the drug before Screening, whichever is longer.
- Blood donation/blood loss >400 mL within 3 months before Screening, or >200 mL within 4 weeks before Screening.
- Average daily smoking of more than 5 cigarettes per day within 3 months before Screening.
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- Weekly alcohol intake exceeding 14 units of alcohol within 3 months before Screening - or positive alcohol breath test on D-1.
- History of drug abuse within 5 years before Screening, or positive urine drug screen on D-1.
- History of active tuberculosis, or positive tuberculosis screening at Screening.
- History of fainting during needle insertion or blood draw, or difficult blood collection.
- Severe infection within 1 month before Screening; or hospitalization due to infection, or receipt of systemic antibiotics/antiviral therapy, within 1 month before Screening.
- Surgery within 3 months before Screening, or planned surgery of Grade 2 or above as defined in the Medical Institution Surgical Procedure Classification Management Measures during the study.
- QT interval corrected by Fridericia's formula (QTcF) ≥450 ms for males or ≥460 ms for females at Screening or on D-1.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), Treponema pallidum-specific antibody, or human immunodeficiency virus antibody (HIV Ab) at Screening.
- Presence of a disease that the investigator judges may affect the pharmacokinetic characteristics of the investigational product.
- Pregnant or lactating women, or positive pregnancy test at Screening or on D-1.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection in Chinese Healthy Adult Participants
This study is a first-in-human Phase 1 clinical study conducted in healthy adult participants in China to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QLS2312 Injection after single and multiple subcutaneous administrations. The study consists of Part A and Part B: Part A is a single-ascending-dose study, and Part B is a multiple-ascending-dose (MAD) study.
- Conditions
- Healthy Participants Study
- Being tested
- QLS2312 Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS2312 InjectionDrug
QLS2312 Injection to be administered by SC injection
PlaceboDrug
Placebo solution to be administered at a matching volume by SC injection
| Study group | Role | What they receive |
|---|---|---|
| QLS2312 Injection | Experimental | Not described Receives: Drug: QLS2312 Injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
Measured: 0-169 days
Secondary outcomes (2)
Maximum serum concentration (Cmax)
Measured: 0-169 days
Area Under The Curve Extrapolated To Infinity (AUCinf)
Measured: 0-169 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start11 Nov 2026 (estimated)
- Primary completion9 Oct 2027 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861581
- Sponsor's protocol ID
- QLS2312-101
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection in Chinese Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07861581
- Acronym / sponsor ID
- QLS2312-101
- Conditions
- Healthy Participants Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTDIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 9 Oct 2027 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 6 Oct 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.
This study is a first-in-human Phase 1 clinical study conducted in healthy adult participants in China to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QLS2312 Injection after single and multiple subcutaneous administrations. The study consists of Part A and Part B: Part A is a single-ascending-dose study, and Part B is a multiple-ascending-dose (MAD) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS2312 Injection | Experimental | Drug: QLS2312 Injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understand and comply with the study procedures, voluntarily participate in this trial, and sign the informed consent form.
- Aged 18-55 years, inclusive.
- Body weight ≥50 kg for males and ≥45 kg for females; body mass index (BMI) 18.5-28.0 kg/m², inclusive.
- Serum IgA, IgG, and IgM are within the normal reference range.
- Medical history review, physical examination, laboratory tests, vital signs, imaging examinations, etc. are normal, or are judged by the investigator as abnormal but not clinically significant.
Key exclusion criteria (16 listed)
- History of definite food or drug allergy, or known allergy to the investigational product or its excipients.
- Prior use of any biologic targeting APRIL or MASP-2.
- Use of any prescription or non-prescription drug within 14 days before Screening, or still within 5 half-lives of the drug before Screening, whichever is longer.
- Use of other therapeutic biologics within 1 month before Screening; or still within 5 half-lives of the drug before Screening, whichever is longer.
- Blood donation/blood loss >400 mL within 3 months before Screening, or >200 mL within 4 weeks before Screening.
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 |
|---|---|---|
| QLS2312 InjectionQLS2312 Injection to be administered by SC injection | Drug | QLS2312 Injection |
| PlaceboPlacebo solution to be administered at a matching volume by SC injection | Drug | Placebo |
Primary outcome
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
Time frame: 0-169 days
2 secondary outcomes
Maximum serum concentration (Cmax)
Time frame: 0-169 days
Area Under The Curve Extrapolated To Infinity (AUCinf)
Time frame: 0-169 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 Oct 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS2312 Injection in people with Healthy Participants Study, run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
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 6 inclusion and 16 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Zhang Rui (+86 18560087298, zrlw2001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs) (time frame: 0-169 days). 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 Oct 2026; AzTrials last refreshed its copy on 5 Nov 2026.