A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
NCT05409326 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2022-06-08
Summary
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.
Conditions
Interventions
- DRUG
-
TQH2722 injection
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
- DRUG
-
Placebo to match TQH2722
TQH2722 is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases.
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-06-30
- Primary Completion
- 2023-06-30
- Completion
- 2023-08-31
Countries
- China
Study Locations
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