Samsung Bioepis Co., Ltd.
🇰🇷South Korea
- Country
- 🇰🇷South Korea
- Ownership
- Subsidiary
- Established
- 2012-01-01
- Employees
- 501
- Market Cap
- -
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: Pen of SB5Biological: PFS of SB5
- First Posted Date
- 2014-12-29
- Last Posted Date
- 2019-03-18
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 190
- Registration Number
- NCT02326233
- Locations
- 🇳🇿
Samsung Investigational Site, Auckland, New Zealand
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: SB5 (proposed biosimilar to adalimumab)
- First Posted Date
- 2014-06-18
- Last Posted Date
- 2017-08-17
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 544
- Registration Number
- NCT02167139
- Locations
- 🇵🇱
Investigational site, Katowice, Poland
🇱🇹Investigational Site, Kaunas, Lithuania
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
Phase 3
Completed
- Conditions
- HER2 Positive Early or Locally Advanced Breast Cancer
- Interventions
- Drug: SB3 (proposed trastuzumab biosimilar)
- First Posted Date
- 2014-05-29
- Last Posted Date
- 2018-10-24
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 875
- Registration Number
- NCT02149524
- Locations
- 🇨🇿
Investigational Site, Praha, Czechia
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: EU sourced Humira®Biological: SB5Biological: US sourced Humira®
- First Posted Date
- 2014-05-22
- Last Posted Date
- 2018-11-14
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 189
- Registration Number
- NCT02144714
- Locations
- 🇩🇪
Samsung Investigational Site, Berlin, Germany
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: US sourced Herceptin®Biological: SB3Biological: EU sourced Herceptin®
- First Posted Date
- 2014-03-03
- Last Posted Date
- 2017-09-14
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 109
- Registration Number
- NCT02075073
- Locations
- 🇩🇪
Samsung Investigational Site, Berlin, Germany
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: SB2 (proposed biosimilar to infliximab)
- First Posted Date
- 2013-09-05
- Last Posted Date
- 2017-09-14
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 584
- Registration Number
- NCT01936181
- Locations
- 🇱🇹
Investigational Site, Santariskiu, Vilnius, Lithuania
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: SB2Biological: US RemicadeBiological: EU Remicade
- First Posted Date
- 2013-08-14
- Last Posted Date
- 2019-02-21
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 159
- Registration Number
- NCT01922336
- Locations
- 🇩🇪
Parexel International GmbH, Berlin, Germany
A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: SB4 (proposed biosimilar to etanercept)
- First Posted Date
- 2013-07-10
- Last Posted Date
- 2017-08-17
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 596
- Registration Number
- NCT01895309
- Locations
- 🇬🇧
Investigational Site, Southampton, Hampshire, United Kingdom
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: SB4Biological: EU sourced EnbrelBiological: US sourced Enbrel
- First Posted Date
- 2013-05-31
- Last Posted Date
- 2019-06-04
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Target Recruit Count
- 138
- Registration Number
- NCT01865552
- Locations
- 🇩🇪
Parexel International GmbH, Berlin, Germany
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