9 completed, 4 unknown, 1 active not recruiting. 7 Phase 1, 5 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 3, Unknown 3, Active not recruiting 1 |
| Phase 3 | 5 | Completed 4, Unknown 1 |
| Phase 2 | 4 | Completed 3, Unknown 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 |
|---|---|---|---|---|---|---|
| A Trial of HBM9378 in Healthy Chinese Subjects HBM9378 (SKB378) Injection, Placebo - Asthma | Phase 1 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 50 | 2022-09-23 | 2026-05-01 |
| Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis HBM9161 Injection (680mg) - Myasthenia Gravis | Phase 3 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 111 | 2022-06-30 | 2026-04-28 |
| HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study HBM4003, Toripalimab, Tislelizumab - Solid Tumors, Neuroendocrine Tumors | Phase 1 | Active not recruiting | Harbour BioMed (Guangzhou) Co. Ltd. | 53 | 2021-12-28 | 2025-04-27 |
| A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combine With Toripalimab in Patients With Advanced HCC and Other Solid Tumors HBM4003 and Triprilimab - Solid Tumors | Phase 1 | Unknown | Harbour BioMed (Guangzhou) Co. Ltd. | 67 | 2021-12-20 | 2021-12-08 |
| Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients HBM9161 Injection (680mg), Placebo - Myasthenia Gravis | Phase 3 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 132 | 2021-09-25 | 2023-03-08 |
| A Study to Evaluate the Efficacy and Safety of HBM9161 on Moderate to Severe Thyroid Eye Disease HBM9161 680 mg qw by q2w from week 13, Placebo, HBM9161 680 mg qw by q2w from week 7 - Thyroid Ophthalmopathy | Phase 2 / Phase 3 | Unknown | Harbour BioMed (Guangzhou) Co. Ltd. | 36 | 2021-09-22 | 2022-02-23 |
| A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody HBM4003 and pembrolizumab - Solid Tumor | Phase 1 | Unknown | Harbour BioMed (Guangzhou) Co. Ltd. | 66 | 2021-06-14 | 2021-04-29 |
| Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab HBM4003 and Triprilimab - Solid Tumors | Phase 1 | Unknown | Harbour BioMed (Guangzhou) Co. Ltd. | 61 | 2021-02-28 | 2021-01-29 |
| A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye HBM9036 0.25% Ophthalmic Solution, Placebo - Dry Eye | Phase 3 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 577 | 2021-02-25 | 2026-04-28 |
| A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP HBM9161 Dose A, HBM9161 Dose B, Placebo - Primary Immune Thrombocytopenic Purpura | Phase 2 / Phase 3 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 36 | 2020-07-24 | 2026-04-28 |
| A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG Patients HBM9161 Injection (680mg and 340 mg), Placebos, HBM9161 Injection (340 mg) - Myasthenia Gravis | Phase 2 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 30 | 2020-07-23 | 2023-03-08 |
| A Study of HBM9161 in NMOSD Patients HBM9161 Injection - NMO Spectrum Disorder | Phase 1 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 9 | 2020-03-31 | 2022-01-25 |
| A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers HBM9161(HL161BKN), Placebo - Healthy Chinese Volunteers | Phase 1 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 24 | 2019-06-03 | 2021-03-10 |
| A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye HBM9036 0.25% Ophthalmic Solution, placebo - Dry Eye | Phase 2 | Completed | Harbour BioMed (Guangzhou) Co. Ltd. | 100 | 2019-03-22 | 2021-08-11 |
Myasthenia Gravis (3) · Dry Eye Syndromes (2) · Asthma (1) · Graves Ophthalmopathy (1) · Neuroendocrine Tumors (1) · Neuromyelitis Optica (1)
HBM9161 (5) · Ophthalmic Solutions (2) · Injections (1) · pembrolizumab (1) · tislelizumab (1) · toripalimab (1)
China (11)
Chongbo Zhao (2) · Huifang Zhou (1) · Jihui Hao, Doctor (1) · Lin Shen, Ph.D (1) · Renchi Yang (1) · Shun LU, Doctor (1) · Wei Qiu (1) · Zuguo Liu, Doctor (1)
PMID 35192105, PMID 35412216, PMID 38436998, PMID 39366752, PMID 40489809, PMID 40521168, PMID 41873335, PMID 42867600