Trials / Not Yet Recruiting
Not Yet RecruitingNCT07400744
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects
Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity (Randomized, Double-blind, Single Dose, Parallel Controlled) of QL2109 With Daratumumab Injection in Healthy Chinese Male Subjects
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL2109 | Recombinant anti-CD38 fully human monoclonal antibody. |
| DRUG | Darzalex | Daratumumab injection |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2026-09-01
- Completion
- 2026-10-01
- First posted
- 2026-02-10
- Last updated
- 2026-02-10
Source: ClinicalTrials.gov record NCT07400744. Inclusion in this directory is not an endorsement.