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A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®

NCT06614907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-03-12

No results posted yet for this study

Summary

It is a randomized, double-blinded, parallel, single-dose, PhaseⅠcomparative study to evaluate the pharmacokinetics and safety of QL2108 to Dupixent® in healthy Chinese adult subjects. A total of 198 healthy subjects are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml QL2108 injection or Dupixent®.

Conditions

Interventions

DRUG

QL2108 injection

300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection

DRUG

Dupixent®

300mg/2.0mL; single dose; prefilled syringe; subcutaneous injection

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qing Wen · Jinan Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2024-11-15
Completion
2024-12-27

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614907 on ClinicalTrials.gov