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

NCT06614907 | Completed Phase 1

• 1 other identifier: QL2108-101
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics Endpoint

  Cmax

  0-8weeks

• Pharmacokinetics Endpoint

  AUC0-∞

  0-8weeks

Study Arms (2)

QL2108 injection

EXPERIMENTAL

QL2108 injection; 300mg/2.0mL; subcutaneous injection

Drug: QL2108 injection

Dupixent®

ACTIVE COMPARATOR

Dupixent®; 300mg/2.0mL; subcutaneous injection

Drug: Dupixent®

Interventions

QL2108 injection DRUG

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

QL2108 injection

Dupixent® DRUG

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

Dupixent®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qing Wen

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: August 31, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 27, 2024
• Last Updated: March 12, 2025

Record last verified: 2024-09

Locations

CN (1)