United BioPharma: Clinical Trials

7 completed, 6 unknown, 2 withdrawn. 7 Phase 2, 6 Phase 1, 2 Phase 3.

By phase and status

Phase	Trials	Status
Phase 2	7	Completed 3, Unknown 3, Withdrawn 1
Phase 1	6	Completed 4, Unknown 2
Phase 3	2	Unknown 1, Withdrawn 1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
To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults UB-421, current standard HAART treatment - HIV-1 Infection	Phase 3	Withdrawn	United BioPharma		2025-04-01	2023-04-25
Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation in HIV Infected Adults UB-421 SC - HIV-1-infection	Phase 1	Unknown	United BioPharma	18	2023-12-31	2022-05-13
Evaluating the Safety and Tolerability and Determining the PK and PD of Single Dose UB-221 in Chronic Spontaneous Urticaria UB-221 - Chronic Idiopathic Urticaria	Phase 1	Unknown	United BioPharma	32	2023-12-30	2022-10-03
UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection UB-421, Antiretroviral (ARV) - HIV-1 Infection	Phase 3	Unknown	United BioPharma	50	2023-12-01	2023-04-24
UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients UB-421, Optimized background therapy (OBT) - HIV-1 Infection	Phase 2	Unknown	United BioPharma	10	2023-12-01	2023-04-24
A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 UB-621, Placebo - Genital Herpes	Phase 2	Unknown	United BioPharma	80	2023-06-01	2022-10-03
A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria UB-221, sterile saline solution - Chronic Spontaneous Urticaria	Phase 2	Unknown	United BioPharma	25	2022-10-05	2022-10-07
A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs UB-421, chidamide - HIV-1 Infection	Phase 2	Completed	United BioPharma	11	2021-12-02	2023-02-15
Study for Evaluation of the Safety, Pharmacokinetics, and Antiviral Activity of UB-421 Subcutaneous Formulation Administered in HIV-1 Infected Treatment Naive Patients UB-421 SC(dB4C7C22-6 mAb) - HIV-1 Infection	Phase 1	Completed	United BioPharma	15	2021-01-01	2023-04-24
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients UB-421, Antiretroviral Therapy (ART) - HIV-1 Infection	Phase 2	Withdrawn	United BioPharma		2020-04-01	2020-02-21
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients UB-221 - Urticaria Chronic	Phase 1	Completed	United BioPharma	15	2019-04-09	2022-05-13
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients UB-421(25 mg/kg) Q2W, UB-421(25 mg/kg) Q4W - HIV-1 Infection	Phase 2	Completed	United BioPharma	31	2018-12-12	2022-05-13
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UB-921 in Healthy Volunteers UB-921, Herceptin - Breast Neoplasm	Phase 1	Completed	United BioPharma	18	2018-03-05	2019-04-03
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers UB-621 - Herpes Simplex Virus Infection	Phase 1	Completed	United BioPharma	15	2015-12-01	2019-04-18
To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults UB-421 - HIV-1 Infection	Phase 2	Completed	United BioPharma	29	2015-06-01	2017-10-31

Conditions studied

Chronic Urticaria (3)  ·  Breast Neoplasms (1)  ·  Herpes Genitalis (1)  ·  Herpes Simplex (1)

Interventions

UB-421 (7)  ·  Anti-Retroviral Agents (1)  ·  Antiretroviral Therapy, Highly Active (1)  ·  N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide (1)  ·  Trastuzumab (1)

Countries

Taiwan (8)  ·  China (1)

Top investigators

Chia Yu Chu, MD (1)  ·  Hsiang-Cheng Chen (1)  ·  Hung Chin Tsai, M.D. PhD. (1)  ·  Wing Wai Wong, M.D. (1)  ·  Wing Wai Wong, MD (1)  ·  Yen Hsu Chen, M.D. PhD. (1)

Results publications

PMID 30995373