Study of SLN12140 in Healthy Adult Participants

NCT06945445 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: LIN2102-CN101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of SLN12140

  Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)

  36 days

Secondary Outcomes (14)

• Pharmacokinetics-Cmax

  36 days

• Pharmacokinetics-Tmax

  36 days

• Pharmacokinetics-AUClast

  36 days

• Pharmacokinetics-AUCinf

  36 days

• Pharmacokinetics-t1/2

  36 days

Study Arms (2)

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

Drug: SLN12140

Placebo

PLACEBO COMPARATOR

Placebo (SLN12140 formulation buffer) will be provided as an injectable solution without active ingredient.

Other: Placebo

Interventions

SLN12140 DRUG

SLN12140 for sc injection or IV infusion

SLN12140

Placebo OTHER

Placebo for sc injection or IV infusion

Placebo

Eligibility Criteria

• Age: 18 Days - 65 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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).
• 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);

Sponsors & Collaborators

• Linno Pharmaceuticals, Inc.: lead

Study Sites (3)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Phase I center of Fudan University Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Jing Zhang, Doctor of Pharmacy

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Xiaojie Wu, Doctor of Pharmacy

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Zhang, Doctor of Pharmacy

CONTACT

0086+13816357098; zhangj_fudan@163.com

Xiaojie Wu, Doctor of Pharmacy

CONTACT

0086+13524686330; maomao_xj@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)