A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection

StatusNot Yet Recruiting
PhasePhase 1
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07861581
Lead Sponsor Shanghai Qilu Pharmaceutical Research and Development Center LTD
Conditions
(from sponsor)		 Healthy Participants Study
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov