A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07400744
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • QL2109 — DRUG
    Recombinant anti-CD38 fully human monoclonal antibody.
  • Darzalex — DRUG
    Daratumumab injection

Study Details

The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects.

Key Dates

First listed
Feb 10, 2026
Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QL2109
  • Active Comparator: Darzalex

Primary Outcome Measure

AUC0-∞ [ Time Frame: Up to Day 71 ]

Central Contacts

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