NCT03659305 is a Phase 1 clinical trial of RPH-001 in Healthy, sponsored by R-Pharm.

Who is sponsoring NCT03659305?

NCT03659305 is sponsored by R-Pharm.

What drugs are being tested in NCT03659305?

Interventions in NCT03659305: RPH-001, Avastin.

Is NCT03659305 still recruiting?

NCT03659305 is currently completed. Last updated 5 February 2019.

Last reviewed 2019-02-05 · How we verify

NCT03659305

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®

Completed Phase 1 Last updated 5 February 2019

What this trial tests

Phase 1 trial testing RPH-001 in Healthy in 80 participants. Completed in 26 January 2019.

Timeline

10 July 2018

Primary endpoint
26 January 2019

26 January 2019

Quick facts

Lead sponsor	R-Pharm
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	10 July 2018
Primary completion	26 January 2019
Estimated completion	26 January 2019
Sites	1 location across Russia

Drugs / interventions tested

RPH-001 — full drug profile →
Avastin — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

R-Pharm — full company profile →

Who can join

Adults 21 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.

Publications & conference data

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

Monoclonal antibody biosimilars for cancer treatment.
Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115
Biosimilar monoclonal antibodies for cancer treatment in adults.
Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2

Verify or expand the search:

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Other R-Pharm trials

Trials by the same sponsor.

NCT07386938 — A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetax · Phase 3 · active not recruiting
NCT07435324 — A Comparative Study of Efficacy and Safety of RPH-002 and Erbitux® in Unresectable Metastatic or Recurrent Head and Neck · Phase 3 · active not recruiting
NCT05773170 — Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxys · completed
NCT04684446 — Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19 · Phase 1, PHASE2 · completed
NCT05196477 — Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03659305 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 R-Pharm
Last refreshed: 5 February 2019

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/NCT03659305.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing