Healthy Volunteers - Male and FemalePhase 1NCT07313150
A Phase I Trial of Subcutaneous QLS7305 in Healthy Adults
A Phase 1 study testing QLS7305 Injection in people with Healthy Volunteers - Male and Female, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- QLS7305 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 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
- Aged between 18 and 55 years (inclusive) Physical examination, vital signs, laboratory tests, 12-lead ECG, and imaging findings are within normal ranges.
- Body weight ≥50 kg for males and ≥45 kg for females, with a BM) between 18.0 and 28 kg/m² (inclusive).
- Willing or has complied with the administration of meningococcal and pneumococcal vaccines as required by the protocol.
- No plan to donate sperm or ova, no pregnancy plan, and voluntarily agrees to use effective contraception methods from the signing of the ICF until 12 months after administration of the investigational product.
- Able to understand and comply with the study procedures, voluntarily participate in the trial, and provide written informed consent.
Who cannot join
- History of food or drug allergy, and/or known allergy to GalNAc. History of definite infection with encapsulated bacteria within 6 months prior to screening.
- History of recurrent or chronic infection within 3 months prior to screening. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 1 month prior to baseline.
- Any disease at screening that, in the investigator's judgment, could affect the study data.
- History of malignancy. Any condition that may affect drug absorption. History of splenectomy or congenital asplenia. History of congenital or acquired complement deficiency or disorder. History of allergic diseases (e.g., allergic asthma, allergic rhinitis).
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 Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of QLS7305 Following Subcutaneous Administration in Healthy Chinese Participants.
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China. The main questions it aims to answer are:
What is the safety and tolerability profile of single and multiple subcutaneous doses of QLS7305 in healthy adults? What are the pharmacokinetic (PK) characteristics of QLS7305 and its major metabolites? What are the pharmacodynamic (PD) effects of QLS7305 on the complement system (e.g., serum C3 levels and complement activity)? Does QLS7305 induce an immunogenic response (anti-drug antibodies)? What is the effect of QLS7305 on the QTc interval? Investigators will compare different dose levels of QLS7305 to a placebo group to see the effects on safety, tolerability, and the measured parameters.
Read more
Participants will:
Be enrolled in one of two parts of the study:
Part A (Single Ascending Dose): Receive a single dose of QLS7305 or placebo. Part B (Multiple Ascending Dose): Receive multiple doses of QLS7305 or placebo (doses selected based on Part A results).
Receive prophylactic antibiotics (Penicillin V) after the first dose until their serum complement C3 level recovers, as a safety precaution.
Undergo close safety monitoring throughout the study, including a follow-up period of up to 337 days to ensure safety parameters return to acceptable levels.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of QLS7305 Injection subcutaneously administered to healthy adults. The secondary objectives are to evaluate the pharmacokinetic (PK) characteristics, the pharmacodynamic (PD) characteristics, the immunogenicity and the effect of subcutaneous injection of QLS7305 injection on QTc interval in healthy adult participants.
This study consists of two parts:
- Part A (SAD): This part employs a randomized, double-blind, placebo-controlled design. It is planned to include 5 sequential dose groups (50 mg, 100 mg, 200 mg, 400 mg, and 800 mg). A total of 36 participants are planned: 4 participants in the first dose group and 8 participants in each subsequent dose group. Within each dose group, participants will be randomized in a 3:1 ratio to receive a single dose of either QLS7305 or placebo. Dose escalation between dose groups will proceed sequentially based on the review of safety, tolerability, and PK/PD data by the SMC. The SMC may adjust the dose levels and decide on the enrollment strategy for the highest cohort (e.g., staggered enrollment) based on participant safety. The study may be terminated early if a dose is deemed intolerable or if the study objectives are met.
- Part B (MAD): This part will also use a randomized, double-blind, placebo-controlled design. It is planned to include 2 to 3 dose groups, with 8 participants in each dose group randomized 3:1 to receive QLS7305 or placebo. The specific dose levels and dosing regimen (e.g., on Day 1 and Day 29) for Part B will be determined by the SMC based on the cumulative data from Part A.
Participants will be screened from Day -77 to Day -2. After providing informed consent, participants will receive vaccinations against Neisseria meningitidis and Streptococcus pneumoniae at least two weeks prior to dosing. Eligible participants will be admitted to the clinic on Day -1 for baseline assessments. Dosing will occur on Day 1 (for both parts) and additionally on Day 29 (for Part B). Intensive safety and PK assessments will be performed. Participants will receive prophylactic antibiotic treatment (e.g., Penicillin V) post-dose, which may be discontinued based on the investigator's assessment of serum complement C3 levels and safety risk.
A long-term follow-up period of up to Day 337 post-dose is planned to monitor safety, PD markers (C3, CP, AP), and immunogenicity. Participants with suppressed complement levels at Day 169 will undergo additional follow-up every 8 weeks until recovery (or until Day 337). After Day 337, the unblinded physician may arrange for further monitoring of specific participants if complement levels remain below predefined recovery thresholds.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- QLS7305 Injection, Placebo Control
- Keywords
- QLS7305, Double-stranded small interfering ribonucleic acid (siRNA) targeting complement, First-in-human, C3, SAD, MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS7305 InjectionDrug
Also called QLS7305
QLS7305 Injection
Placebo ControlDrug
Also called Placebo
The placebo is a sterile solution that matches the appearance, volume, and packaging of the QLS7305 injection. It contains no active pharmaceutical ingredient and is administered subcutaneously following the same dosing schedule as the active comparator (single or multiple doses).
| Study group | Role | What they receive |
|---|---|---|
| QLS7305 | Experimental | QLS7305 Injection Receives: Drug: QLS7305 Injection |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of TEAEs
Measured: 337 days
Secondary outcomes (2)
Plasma and urine concentrations of QLS7305
Measured: 337 days
Relationship between plasma concentration of QLS7305 and the change in QTc interval.
Measured: D3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Jing, Professor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313150
- Sponsor's protocol ID
- QLS7305-101
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data that underlie the results reported in the primary publication (for the primary and secondary endpoints).
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of QLS7305 Following Subcutaneous Administration in Healthy Chinese Participants.
- ClinicalTrials.gov ID
- NCT07313150
- Acronym / sponsor ID
- QLS7305-101
- Conditions
- Healthy Volunteers - Male and Female
- Keywords
- QLS7305, Double-stranded small interfering ribonucleic acid (siRNA) targeting complement, First-in-human, C3, SAD, MAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Dec 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 goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China. The main questions it aims to answer are:
What is the safety and tolerability profile of single and multiple subcutaneous doses of QLS7305 in healthy adults? What are the pharmacokinetic (PK) characteristics of QLS7305 and its major metabolites? What are the pharmacodynamic (PD) effects of QLS7305 on the complement system (e.g., serum C3 levels and complement activity)? Does QLS7305 induce an immunogenic response (anti-drug antibodies)? What is the effect of QLS7305 on the QTc interval? Investigators will compare different dose levels of QLS7305 to a placebo group to see the effects on safety, tolerability, and the measured parameters.
Participants will:
Be enrolled in one of two parts of the study:
Part A (Single Ascending Dose): Receive a single dose of QLS7305 or placebo. Part B (Multiple Ascending Dose): Receive multiple doses of QLS7305 or placebo (doses selected based on Part A results).
Receive prophylactic antibiotics (Penicillin V) after the first dose until their serum complement C3 level recovers, as a safety precaution.
Undergo close safety monitoring throughout the study, including a follow-up period of up to 337 days to ensure safety parameters return to acceptable levels.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of QLS7305 Injection subcutaneously administered to healthy adults. The secondary objectives are to evaluate the pharmacokinetic (PK) characteristics, the pharmacodynamic (PD) characteristics, the immunogenicity and the effect of subcutaneous injection of QLS7305 injection on QTc interval in healthy adult participants.
This study consists of two parts:
- Part A (SAD): This part employs a randomized, double-blind, placebo-controlled design. It is planned to include 5 sequential dose groups (50 mg, 100 mg, 200 mg, 400 mg, and 800 mg). A total of 36 participants are planned: 4 participants in the first dose group and 8 participants in each subsequent dose group. Within each dose group, participants will be randomized in a 3:1 ratio to receive a single dose of either QLS7305 or placebo. Dose escalation between dose groups will proceed sequentially based on the review of safety, tolerability, and PK/PD data by the SMC. The SMC may adjust the dose levels and decide on the enrollment strategy for the highest cohort (e.g., staggered enrollment) based on participant safety. The study may be terminated early if a dose is deemed intolerable or if the study objectives are met.
- Part B (MAD): This part will also use a randomized, double-blind, placebo-controlled design. It is planned to include 2 to 3 dose groups, with 8 participants in each dose group randomized 3:1 to receive QLS7305 or placebo. The specific dose levels and dosing regimen (e.g., on Day 1 and Day 29) for Part B will be determined by the SMC based on the cumulative data from Part A.
Participants will be screened from Day -77 to Day -2. After providing informed consent, participants will receive vaccinations against Neisseria meningitidis and Streptococcus pneumoniae at least two weeks prior to dosing. Eligible participants will be admitted to the clinic on Day -1 for baseline assessments. Dosing will occur on Day 1 (for both parts) and additionally on Day 29 (for Part B). Intensive safety and PK assessments will be performed. Participants will receive prophylactic antibiotic treatment (e.g., Penicillin V) post-dose, which may be discontinued based on the investigator's assessment of serum complement C3 levels and safety risk.
A long-term follow-up period of up to Day 337 post-dose is planned to monitor safety, PD markers (C3, CP, AP), and immunogenicity. Participants with suppressed complement levels at Day 169 will undergo additional follow-up every 8 weeks until recovery (or until Day 337). After Day 337, the unblinded physician may arrange for further monitoring of specific participants if complement levels remain below predefined recovery thresholds.
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 |
|---|---|---|
| QLS7305 | Experimental | Drug: QLS7305 InjectionQLS7305 Injection |
| Placebo | Placebo comparator | Drug: Placebo ControlPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 and 55 years (inclusive) Physical examination, vital signs, laboratory tests, 12-lead ECG, and imaging findings are within normal ranges.
- Body weight ≥50 kg for males and ≥45 kg for females, with a BM) between 18.0 and 28 kg/m² (inclusive).
- Willing or has complied with the administration of meningococcal and pneumococcal vaccines as required by the protocol.
- No plan to donate sperm or ova, no pregnancy plan, and voluntarily agrees to use effective contraception methods from the signing of the ICF until 12 months after administration of the investigational product.
- Able to understand and comply with the study procedures, voluntarily participate in the trial, and provide written informed consent.
Key exclusion criteria (4 listed)
- History of food or drug allergy, and/or known allergy to GalNAc. History of definite infection with encapsulated bacteria within 6 months prior to screening.
- History of recurrent or chronic infection within 3 months prior to screening. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 1 month prior to baseline.
- Any disease at screening that, in the investigator's judgment, could affect the study data.
- History of malignancy. Any condition that may affect drug absorption. History of splenectomy or congenital asplenia. History of congenital or acquired complement deficiency or disorder. History of allergic diseases (e.g., allergic asthma, allergic rhinitis).
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 |
|---|---|---|
| QLS7305 InjectionAlso: QLS7305QLS7305 Injection | Drug | QLS7305 |
| Placebo ControlAlso: PlaceboThe placebo is a sterile solution that matches the appearance, volume, and packaging of the QLS7305 injection. It contains no active pharmaceutical ingredient and is administered subcutaneously following the same dosing schedule as the active comparator (single or multiple doses). | Drug | Placebo |
Primary outcome
Incidence and severity of TEAEs
Time frame: 337 days
2 secondary outcomes
Plasma and urine concentrations of QLS7305
Time frame: 337 days
Relationship between plasma concentration of QLS7305 and the change in QTc interval.
Time frame: D3
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 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data that underlie the results reported in the primary publication (for the primary and secondary endpoints).
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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.
Zhang Jing, Professor principal investigator
Huashan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS7305 Injection in people with Healthy Volunteers - Male and Female, run by Qilu Pharmaceutical Co., 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 5 inclusion and 4 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 31 Dec 2025. 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 Wu Cuiyun, Professor (021-5288 8921, wucuiyun@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of TEAEs (time frame: 337 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 31 Dec 2025.