NCT03722329 is a Phase 1 clinical trial of Eculizumab in Healthy, sponsored by Samsung Bioepis Co., Ltd..

Who is sponsoring NCT03722329?

NCT03722329 is sponsored by Samsung Bioepis Co., Ltd..

What drugs are being tested in NCT03722329?

Interventions in NCT03722329: Eculizumab.

Is NCT03722329 still recruiting?

NCT03722329 is currently completed. Last updated 9 January 2020.

Last reviewed 2020-01-09 · How we verify

NCT03722329

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

Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

Completed Phase 1 Last updated 9 January 2020

What this trial tests

Phase 1 trial testing Eculizumab in Healthy in 240 participants. Completed in 8 April 2019.

Timeline

13 November 2018

Primary endpoint
29 March 2019

8 April 2019

Quick facts

Lead sponsor	Samsung Bioepis Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	240
Start date	13 November 2018
Primary completion	29 March 2019
Estimated completion	8 April 2019
Sites	1 location across Germany

Drugs / interventions tested

Eculizumab (ECULIZUMAB) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Samsung Bioepis Co., Ltd. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.

Publications & conference data

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

Clinical promise of next-generation complement therapeutics.
Mastellos DC, Ricklin D, Lambris JD. · · 2019 · cited 255× · PMID 31324874 · DOI 10.1038/s41573-019-0031-6
A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria.
Jang JH, Gomez RD, Bumbea H, Nogaieva L, et al · · 2023 · cited 15× · PMID 36819188 · DOI 10.1002/jha2.632
Targeting complement cascade: an alternative strategy for COVID-19.
Ram Kumar Pandian S, Arunachalam S, Deepak V, Kunjiappan S, et al · · 2020 · cited 13× · PMID 33088671 · DOI 10.1007/s13205-020-02464-2
A randomized, double-blind, three-arm, parallel group, single-dose phase I study to evaluate the pharmacokinetic similarity between SB12 (a proposed eculizumab biosimilar) and eculizumab (Soliris) in healthy subjects.
Lee HA, Jang H, Jeong D, Kim Y, et al · · 2022 · cited 6× · PMID 35348111 · DOI 10.5414/cp204176
The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome.
Jang JH, Han B, Jung J, Russo P, et al · · 2025 · cited 3× · PMID 39982653 · DOI 10.1007/s40259-025-00707-3
EPYSQLI (SB12; Biosimilar to Reference Eculizumab) in Asian and Non-Asian Patients With Paroxysmal Nocturnal Hemoglobinuria: Subgroup Analysis of a Global Phase III Randomized Controlled Trial.
Jang JH, Tomuleasa C, Oliynyk H, Lanamtieng T, et al · · 2025 · PMID 40123793 · DOI 10.1002/jha2.70020

Verify or expand the search:

Other trials of Eculizumab

Trials testing the same drug.

NCT06764160 — Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG · Phase 3 · completed
NCT06513338 — Complement C5 mAb in the Treatment of Anti-GBM Disease · Phase 2 · completed
NCT05876351 — Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China · Phase 3 · completed
NCT05886244 — Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China · Phase 3 · completed
NCT05131204 — Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment · Phase 3 · terminated

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 Samsung Bioepis Co., Ltd. trials

Trials by the same sponsor.

NCT06176963 — A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO · Phase 2 · completed
NCT05510063 — Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic · Phase 4 · completed
NCT04967508 — A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasi · Phase 3 · completed
NCT04772274 — A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of Am · Phase 1 · completed
NCT04664959 — A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis · Phase 3 · 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 NCT03722329 (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 Samsung Bioepis Co., Ltd.
Last refreshed: 9 January 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/NCT03722329.

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