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NCT03912441

First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects

Completed Phase 1 Last updated 18 September 2020
What this trial tests

Phase 1 trial testing BCD-147 in Healthy in 15 participants. Completed in 30 September 2019.

Timeline
30 January 2019
Primary endpoint
30 September 2019
30 September 2019

Quick facts

Lead sponsorBiocad
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment15
Start date30 January 2019
Primary completion30 September 2019
Estimated completion30 September 2019
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

Biocad — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biology drives the discovery of bispecific antibodies as innovative therapeutics.
    Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
  2. Biparatopic antibodies: therapeutic applications and prospects.
    Niquille DL, Fitzgerald KM, Gera N. · · 2024 · cited 41× · PMID 38439551 · DOI 10.1080/19420862.2024.2310890
  3. Anti-ErbB2 immunotherapeutics: struggling to make better antibodies for cancer therapy.
    De Santis R. · · 2020 · cited 16× · PMID 32054397 · DOI 10.1080/19420862.2020.1725346
  4. Bispecific antibodies for the treatment of breast cancer.
    Dillon PM, Tushir-Singh J, Lum LG. · · 2022 · cited 11× · PMID 33896311 · DOI 10.1080/14712598.2021.1922665

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Other recruiting trials for Healthy

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Data sources for this page

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