eligibility_summary
Eligible: healthy men 18–45, BMI 18.5–30, normal BP/HR, able to comply, no substance abuse, agree to condoms and no conception/sperm donation for 3 months, avoid alcohol around dosing, smoking before checks, live vaccines, and nonstudy meds, no blood/plasma donation for 6 months. Exclude: compliance‑limiting illness, recent surgery, severe/mAb allergy, recent meds (incl anti‑CD38), positive HIV/HBV/HCV/Coombs, abnormal labs, chronic/acute disease, heavy smoking/alcohol, recent/prior trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05974969 is a Phase 1, randomized, double-blind, parallel study in healthy adults comparing a single IV dose (8 mg/kg) of BCD-264 (a proposed daratumumab biosimilar by Biocad) versus Darzalex (daratumumab). Drug type/mechanism: Daratumumab is a fully human IgG1κ monoclonal antibody targeting CD38, a transmembrane ectoenzyme. It induces tumor cell kill via complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and apoptosis, and modulates CD38 enzymatic (NADase) activity. Targets: CD38-expressing cells—primarily plasma cells (malignant and normal), plus subsets of NK, B, and T cells—and associated pathways including Fcγ receptor effector functions, complement cascade, and CD38/NAD+ signaling. Objective: demonstrate PK/PD comparability, safety, and immunogenicity. Completed Aug 2023 in Russia.