Last reviewed · How we verify
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
Phase 1 trial testing BCD-147 in Healthy in 15 participants. Completed in 30 September 2019.
30 September 2019
Quick facts
| Lead sponsor | Biocad |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 30 January 2019 |
| Primary completion | 30 September 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- BCD-147 — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
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):
-
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 -
Biparatopic antibodies: therapeutic applications and prospects.
Niquille DL, Fitzgerald KM, Gera N. · · 2024 · cited 41× · PMID 38439551 · DOI 10.1080/19420862.2024.2310890 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03912441
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Biocad trials
Trials by the same sponsor.
- NCT07136389 — Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects With Systemic Lupus Erythematosus · Phase 1 · recruiting
- NCT05974969 — A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subject · Phase 1 · completed
- NCT05802225 — Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer · Phase 3 · active not recruiting
- NCT05726630 — Clinical Study of Divozilimab in Patients With Systemic Scleroderma · Phase 3 · active not recruiting
- NCT05738993 — A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single I · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03912441 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biocad
- Last refreshed: 18 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03912441.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing