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.
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.
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.
Sequential
QLS2312 Injection
DrugQLS2312 Injection to be administered by SC injection
Placebo
DrugPlacebo solution to be administered at a matching volume by SC injection
Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs)
Maximum serum concentration (Cmax)
Area Under The Curve Extrapolated To Infinity (AUCinf)
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This trial is not recruiting at the moment. You can still explore other options:
