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

NCT06614907
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Phase
Phase 1
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Recruitment status
Completed
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Participants
198
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Lead sponsor
Qilu Pharmaceutical Co., Ltd.
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Start date
2024-08-31
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Number of sites
1
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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®.
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Short title
A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®
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Official title
A Randomized, Double-blinded, Parallel, Single-dose, PhaseⅠComparative Study to Evaluate the Pharmacokinetics and Safety of QL2108 to Dupixent® in Healthy Chinese Adult Subjects
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2024-12-27
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First posted
2024-09-26
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Registry last updated
2025-03-12
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Primary completion date
2024-11-15
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Start date
2024-08-31
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Actual participants
198
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Participants
198
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Participant count basis
Actual
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Protocol amendments
2
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Randomisation ratio
1:1
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Qilu Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06614907
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ClinicalTrials.gov ID
NCT06614907
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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  1. Pharmacokinetics Endpoint

    Timeframe: 0-8weeks

    Cmax

  2. Pharmacokinetics Endpoint

    Timeframe: 0-8weeks

    AUC0-∞

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
50 Years
Healthy volunteers
Yes

  • Chinese healthy subjects aged from 18 to 50 years (including the boundary value)
  • Normal vital signs, physical examinations, ECG, clinical laboratory tests and imageological examination results or abnormal with no clinical significance according to the doctor's judgment;
  • Body weight between 50-90kg and BMI between 19.0-26.0kg/m2 (including boundary value);

  • People who have previously used or participated in clinical trials of monoclonal antibody with the same target or dupilumab
  • People with a clear history of allergy and/or allergy to monoclonal antibodies of the same target /investigational drugs and their components.
  • People who have special dietary requirements or are unable to follow a uniform diet.
  • Dizzy blood, dizzy needle history. Blood donation > 400 ml within 3 months or > 200 ml within 4 weeks prior to screening, or planning to donate blood during the study.
  • Having participated in drug or device clinical trials within 3 months or 5 half-lives of other investigational drugs before the study administration.
Sources for eligibility
clinicaltrials.gov

  • Jinan Central HospitalJinan, China
Sources for sites
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Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)