Healthy VolunteerPhase 1NCT06945445
Study of SLN12140 in Healthy Adult Participants
A Phase 1 study testing SLN12140 in people with Healthy Volunteer, run by Linno Pharmaceuticals, Inc. at 3 sites in China.
Trial summary
A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous/intravenous dose escalation and multiple subcutaneous administrations Read more about this study
- Who is it for?
- Ages 18 to 65 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- SLN12140
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 3 sitesChina
- Study dates
- Apr 2025to Jun 2026
- 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 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Voluntarily participate in clinical trials and sign written informed consent, and be able to complete the whole trial process according to the requirements of the trial.
- Persons of any gender, aged between 18 and 65 years old (including the boundary value).
- Weight: male ≥50kg , female ≥45kg ; Body mass index (BMI) within the range of 19.0 to 28.0 kg/m2 (including cut-off values).
- Those whose medical history, physical examination, vital signs examination, electrocardiogram examination, laboratory examination indicators, and anteroposterior chest X-ray are all normal or abnormal but non clinically significant as judged by the investigator.
- Participant has received the following vaccines:
- Meningococcal polysaccharide vaccine ACYW135 (MPV-ACYW) or meningococcal polysaccharide conjugate vaccine ACYW135 (MPCV-ACYW), given at least two weeks before the first dose and no earlier than within 2 years before the first dose;
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- 13-valent pneumococcal conjugate vaccine (PCV13) or 23-valent pneumococcal polysaccharide vaccine (PPV23) at least two weeks before the first dose, and no earlier than 8 weeks before the first dose of PCV13 and no earlier than 4 years before the first dose of PPV23.
- Normal or abnormal but no clinical significance with ECG results ,such as QTcF interval ≤450ms (males) and QTcF interval ≤470ms (females); PR interval ≤ 209 ms; The QRS interval ≤ 120 ms.
- During the study period and within 3 months after the last dose of the study, there is no childcare plan and can take highly effective contraceptive measures and cannot donate sperm or eggs.
Who cannot join
- Have cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or nervous system diseases that affect the absorption, distribution, metabolism or elimination of drugs; or those with disease or medical history that may interfere with the interpretation of study data.
- Those who have any previous history of Neisseria meningitidis.
- Those who have a positive skin test for penicillin. Those who have known allergies or contraindications to penicillin or any vaccine ingredients, or who are known to be allergic to the trial drug and any of its ingredients or related preparations, or who have any history of allergies to food, drugs, or allergic diseases or allergies.
- Those who have or are suspected of having any active viral, bacterial, fungal or parasitic infection, or receiving any anti-infective treatment within 1 month prior to screening.
- Those with a history of recurrent or chronic infection (such as recurrent upper respiratory tract infection, diarrhea, etc.) within 3 months before screening.
- Within 1 month prior to screening, have received a live attenuated vaccine, or plan to receive a vaccine during the study (except for vaccinations required for the study).
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- Received drugs that may interact with penicillin V potassium within 7 days or 5 elimination half-lives (whichever is longer) prior to dosing.
- Those who have any of the following abnormalities in laboratory tests during the screening stage:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) exceeds the normal range;
- Total bilirubin (TBIL) ≥ 1.5 times the upper limit of normal (ULN);
- eGRF (CKD-EPI formula) <90 mL/min/1.73m2;
- Hemoglobin < lower limit of normal range (LLN).
- At the time of screening, the results of complement C3 and C4 examinations are lower than the lower limit of the normal reference value range and the abnormalities judged by the investigator to be clinically significant.
- Immunocompromised, or suffering from at least one of the following underlying diseases:
- Anatomical or functional asplenia (including sickle cell disease);
- Congenital complement deficiency (complement factor P deficiency, complement factor B deficiency, or complement factor D deficiency);
- Acquired complement deficiency;
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome.
- Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody (TPPA) and HIV antibody.
- Those who have donated or lost more than 400 mL of blood or have a history of blood transfusion within 30 days before screening or Day-1.
- Within 90 days prior to screening or Day-1, the participant has received investigational drug administration, or is currently participating in another clinical study (including the follow-up period).
- Participants who have used any prescription or over-the-counter medications, any vitamin products, or herbal remedies within 7 days prior to dosing.
- Those who have any history of intolerance to subcutaneous injection or related injection site scars (surgery, burns, tattoos, etc.) that would affect the evaluation of injectable drug administration.
- Those who are unwilling or unable to use antibiotic prophylaxis specified in the protocol.
- A person who falls under any of the following conditions:
- Professionals at high risk of exposure to meningococcal disease
- Research, industrial, or clinical laboratory personnel who are at risk of exposure to meningococcals
- Planned travel to areas where meningococcal is endemic (e.g., India, sub-Saharan Africa, Saudi Arabia) during the study period, or have traveled to these areas within 6 months of the day prior to the start of the study.
- A current or former drug abuser.
- Day-1 Positive Drug Abuse Screen.
- Those who have been an alcoholic within the current period of 3 months or in the past (drinking more than 14 standard units per week. 1 standard unit contains 14 g of alcohol, e.g. 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine).
- Those who have a positive Day-1 alcohol breath test (>0.0mg/100mL).
- Use of more than 10 cigarettes (or equivalent nicotine-containing products) per week or more than 5 cigarettes (or equivalent nicotine-containing products) per day within 4 weeks prior to screening.
- Day-1 urine cortinine test positive.
- Those who have taken a special diet (including dragon fruit, mango, grapefruit, etc.) within 24 hours before administration or have strenuous exercise, or other factors that affect the absorption, distribution, metabolism, and excretion of drugs.
- Pregnant or lactating female participants or those with a positive pregnancy test.
- Those who are unable to receive venipuncture, or faint blood and faint needles.
- Those who are considered by the investigator to have other factors that are not suitable for participating in the trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Phase I center of Fudan University Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Jing Zhang, Doctor of Pharmacy, 0086+13816357098, zhangj_fudan@163.com
Xiaojie Wu, Doctor of Pharmacy, 0086+13524686330, maomao_xj@163.com
Huashan Hospital
Shanghai, Shanghai Municipality
Jing Zhang, Principal Investigator
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of SLN12140 Administered Subcutaneously or Intravenously in Healthy Adult Volunteers
A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous/intravenous dose escalation and multiple subcutaneous administrations
Read the detailed description
This study will include up to 7 different dosing cohorts, with each cohort consisting of 2 groups (SLN12140 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 7 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.
The study will be conducted in healthy adult participants .
- Conditions
- Healthy Volunteer
- Being tested
- SLN12140, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN12140Drug
SLN12140 for sc injection or IV infusion
PlaceboOther
Placebo for sc injection or IV infusion
| Study group | Role | What they receive |
|---|---|---|
| SLN12140 | Experimental | a single dose of SLN12140 by subcutaneous (sc) injection:50mg ; a single dose of SLN12140 by subcutaneous (sc) injection:150mg; a single dose of SLN12140 by subcutaneous (sc) injection:450mg ; a single dose of SLN12140 by intravenous(IV) injection:450mg ; a single dose of SLN12140 by subcutaneous (sc) injection:900mg ; a single dose of SLN12140 by subcutaneous (sc) injection:1500mg~1800mg Receives: Drug: SLN12140 |
| Placebo | Placebo comparator | Placebo (SLN12140 formulation buffer) will be provided as an injectable solution without active ingredient. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SLN12140
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Measured: 36 days
Secondary outcomes (14)
Pharmacokinetics-Cmax
Maximum Observed Plasma Concentration (Cmax)
Measured: 36 days
Pharmacokinetics-Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Measured: 36 days
Pharmacokinetics-AUClast
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
Measured: 36 days
Pharmacokinetics-AUCinf
Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)
Measured: 36 days
Pharmacokinetics-t1/2
Terminal Elimination Half-Life (t1/2)
Measured: 36 days
Pharmacokinetics-Vd/F
Volume of Distribution (Vd/F)
Measured: 36 days
Pharmacokinetics-CL/F
Total Body Clearance
Measured: 36 days
Pharmacokinetics-λz
Elimination rate constant (λz)
Measured: 36 days
Pharmacokinetics-MRT
Mean retention time (MRT)
Measured: 36 days
Pharmacokinetics-AUC 0-t, sc/AUC 0-t,iv；AUC 0-inf, sc/ AUC 0-inf,iv
Subcutaneous bioavailability-(AUC 0-t, sc/AUC 0-t,iv；AUC 0-inf, sc/ AUC 0-inf,iv)
Measured: 36 days
Pharmacodynamics-CFP
Change From Baseline in Total and Free Complement factor P (CFP)
Measured: 36 days
Pharmacodynamics-AP activity
Change From Baseline in alternative pathway activity (AP)
Measured: 36 days
Pharmacodynamics-CP, LP Activity
Change From Baseline in Classical pathway and Lectin Pathway (CP, LP)
Measured: 36 days
Immunogenicity-ADA, Nab
Anti-drug antibody positive rate (ADA); ADA titer and Neutralizing antibody rate (Nab)
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linno Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Doctor of Pharmacy, Principal investigator, Huashan HospitalXiaojie Wu, Doctor of Pharmacy, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945445
- Sponsor's protocol ID
- LIN2102-CN101
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of SLN12140 Administered Subcutaneously or Intravenously in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06945445
- Acronym / sponsor ID
- LIN2102-CN101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Linno Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Apr 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.
A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SLN12140 in healthy participants with single subcutaneous/intravenous dose escalation and multiple subcutaneous administrations
Detailed description
This study will include up to 7 different dosing cohorts, with each cohort consisting of 2 groups (SLN12140 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 7 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.
The study will be conducted in healthy adult participants .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLN12140 | Experimental | Drug: SLN12140a single dose of SLN12140 by subcutaneous (sc) injection:50mg ; a single dose of SLN12140 by subcutaneous (sc) injection:150mg; a single dose of SLN12140 by subcutaneous (sc) injection:450mg ; a single dose of SLN12140 by intravenous(IV) injection:450mg ; a single dose of SLN12140 by subcutaneous (sc) injection:900mg ; a single dose of SLN12140 by subcutaneous (sc) injection:1500mg~1800mg |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (SLN12140 formulation buffer) will be provided as an injectable solution without active ingredient. |
Who may qualify
- Ages
- 18 to 65 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Voluntarily participate in clinical trials and sign written informed consent, and be able to complete the whole trial process according to the requirements of the trial.
- Persons of any gender, aged between 18 and 65 years old (including the boundary value).
- Weight: male ≥50kg , female ≥45kg ; Body mass index (BMI) within the range of 19.0 to 28.0 kg/m2 (including cut-off values).
- Those whose medical history, physical examination, vital signs examination, electrocardiogram examination, laboratory examination indicators, and anteroposterior chest X-ray are all normal or abnormal but non clinically significant as judged by the investigator.
- Participant has received the following vaccines:
Key exclusion criteria (38 listed)
- Have cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or nervous system diseases that affect the absorption, distribution, metabolism or elimination of drugs; or those with disease or medical history that may interfere with the interpretation of study data.
- Those who have any previous history of Neisseria meningitidis.
- Those who have a positive skin test for penicillin. Those who have known allergies or contraindications to penicillin or any vaccine ingredients, or who are known to be allergic to the trial drug and any of its ingredients or related preparations, or who have any history of allergies to food, drugs, or allergic diseases or allergies.
- Those who have or are suspected of having any active viral, bacterial, fungal or parasitic infection, or receiving any anti-infective treatment within 1 month prior to screening.
- Those with a history of recurrent or chronic infection (such as recurrent upper respiratory tract infection, diarrhea, etc.) within 3 months 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 |
|---|---|---|
| SLN12140SLN12140 for sc injection or IV infusion | Drug | SLN12140 |
| PlaceboPlacebo for sc injection or IV infusion | Other | Placebo |
Primary outcome
Safety and tolerability of SLN12140
Time frame: 36 days
Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
14 secondary outcomes
Pharmacokinetics-Cmax
Time frame: 36 days
Pharmacokinetics-Tmax
Time frame: 36 days
Pharmacokinetics-AUClast
Time frame: 36 days
Pharmacokinetics-AUCinf
Time frame: 36 days
Pharmacokinetics-t1/2
Time frame: 36 days
Pharmacokinetics-Vd/F
Time frame: 36 days
Pharmacokinetics-CL/F
Time frame: 36 days
Pharmacokinetics-λz
Time frame: 36 days
Pharmacokinetics-MRT
Time frame: 36 days
Pharmacokinetics-AUC 0-t, sc/AUC 0-t,iv；AUC 0-inf, sc/ AUC 0-inf,iv
Time frame: 36 days
Pharmacodynamics-CFP
Time frame: 36 days
Pharmacodynamics-AP activity
Time frame: 36 days
Pharmacodynamics-CP, LP Activity
Time frame: 36 days
Immunogenicity-ADA, Nab
Time frame: 36 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 25 Apr 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jing Zhang, Doctor of Pharmacy principal investigator
Huashan Hospital
Xiaojie Wu, Doctor of Pharmacy principal investigator
Huashan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SLN12140 in people with Healthy Volunteer, run by Linno Pharmaceuticals, Inc. at 3 sites 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 9 inclusion and 38 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Jing Zhang, Doctor of Pharmacy (0086+13816357098, zhangj_fudan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SLN12140 (time frame: 36 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 25 Apr 2025.