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This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple ascending subcutaneous doses in healthy Chinese adults. The study consists of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Participants will be randomly assigned to receive either QL2401 or placebo. The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of PK parameters in SAD & MAD; exploratory objectives include assessment of PD biomarkers and immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2401 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL2401 | Drug | QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Safety and tolerability as assessed by the incidence and severity. | From baseline up to 29 days after last dose (SAD) or 57 days after last dose(MAD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dandan Guo, MD | Contact | +86-0531-5582-1177 | dandan1.guo@qilu-pharma.com |
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| Placebo | Drug | Matching placebo administered via subcutaneous injection. |
|