10 completed, 3 terminated, 1 withdrawn. 10 Phase 1, 3 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 8, Terminated 2 |
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 3 | Completed 1, Terminated 1, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects Biocon's Human Insulin R U-500, Humulin® R U-500 (US Reference Product) - Healthy Volunteers | Phase 1 | Completed | Biocon Limited | 78 | 2022-05-30 | 2023-05-09 |
| A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR) Itolizumab, EQ001 Placebo - Graft Versus Host Disease, GVHD | Phase 3 | Terminated | Equillium | 158 | 2022-04-29 | 2025-06-17 |
| A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 EQ001, EQ001 Placebo - Coronavirus | Phase 3 | Withdrawn | Biocon Limited | 2020-11-01 | 2026-05-12 | |
| Efficacy and Safety of Itolizumab in COVID-19 Complications Itolizumab IV infusion, Best supportive care (BSC) - Acute Respiratory Distress Syndrome, Cytokine Release Syndrome | Phase 2 | Completed | Biocon Limited | 32 | 2020-05-01 | 2021-06-14 |
| Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil Tregopil - Type 1 Diabetes Mellitus (T1DM) | Phase 1 | Terminated | Biocon Limited | 55 | 2019-10-28 | 2022-06-27 |
| Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis Itolizumab [Bmab 600] - Lupus Erythematosus, Lupus Nephritis | Phase 1 | Completed | Biocon Limited | 52 | 2019-10-01 | 2026-06-04 |
| A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD EQ001, EQ001 Placebo - Acute-graft-versus-host Disease, aGVHD | Phase 1 / Phase 2 | Completed | Biocon Limited | 30 | 2019-07-15 | 2026-06-11 |
| A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma EQ001, EQ001 Placebo - Asthma | Phase 1 | Completed | Biocon Limited | 18 | 2019-06-20 | 2026-06-02 |
| Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R Biocon Insulin R, Humulin®R - Healthy Volunteer | Phase 1 | Completed | Biocon Limited | 42 | 2019-06-18 | 2021-07-28 |
| Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30 Humulin ®70/30, Biocon Insulin 70/30 - Healthy Volunteer | Phase 1 | Completed | Biocon Limited | 78 | 2019-06-15 | 2020-01-30 |
| Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N Biocon Insulin N, Humulin® N - Healthy Volunteer | Phase 1 | Completed | Biocon Limited | 90 | 2019-06-15 | 2020-01-30 |
| Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients Insulin Tregopil, Insulin Aspart - Type2 Diabetes Mellitus | Phase 2 / Phase 3 | Completed | Biocon Limited | 143 | 2017-12-26 | 2020-05-15 |
| Effect of Dosing Time and Meal on IN-105 (Insulin Tregopil) PK and PD IN-105 (Insulin Tregopil), Placebo comparator - Type 2 Diabetes Mellitus | Phase 1 | Completed | Biocon Limited | 51 | 2014-03-27 | 2018-01-23 |
| Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients IN-105, Insulin Lispro Injection - Type 1 Diabetes Mellitus | Phase 1 | Terminated | Biocon Limited | 20 | 2010-08-21 | 2018-01-23 |
COVID-19 (2) · Diabetes Mellitus, Type 1 (2) · Graft vs Host Disease (2) · Asthma (1) · Coronavirus Infections (1) · Cytokine Release Syndrome (1) · Diabetes Mellitus, Type 2 (1) · Lupus Erythematosus, Systemic (1) · Lupus Nephritis (1) · Respiratory Distress Syndrome (1)
itolizumab (5) · Indium-105 (3) · Insulin Aspart (1) · Insulin Lispro (1)
Germany (6) · India (4) · United States (3) · Australia (2) · New Zealand (2) · Belgium (1) · Canada (1) · Colombia (1) · France (1) · Israel (1) · Italy (1) · Poland (1) · Portugal (1) · South Korea (1) · Spain (1)
Dr Bipin Kumar Sethi, MD, DM (1) · Dr. Aravind R Sosale, DNB (1) · Dr. Grit Andersen (1) · Dr. K.M. Prasanna Kumar, MD, DM (1) · Dr. Neeta Deshpande, MD (1) · Dr. Sanjay Kalra, MD, DM (1) · Jo A Douglass, MD (1) · Joel Rothman (1) · Juan Carlos Rondon, M.D,JD (1) · Kenneth Kalunian, MD (1) · Maple Fung, MD (1)