Clinical trials

9

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Condition / disease
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Status: Not yet recruiting

A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.

Participants needed: 21
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Mar 4, 2026Locations: 1
Eligibility criteria

1. Participants with known hypersensitivity to HB0043 or any of its excipients;...

Status: Not yet recruiting

Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer

This study is a randomized, controlled, double-blind, multicenter Phase III registration clinical trial, aiming to evaluate the efficacy and safety of HB0025 combined with chemotherapy (pemetrexed plus carboplatin/cisplatin) versus tislelizumab combined with chemotherapy (pemetrexed plus carboplatin/cisplatin) as a first-line treatment for unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) nonsquamous non-small cell lung cancer (NSCLC). The study will take progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) as the primary endpoint, and plans to enroll approximately 500 subjects. After being eligible for screening, patients will be randomly assigned to the study groups at a ratio of 1:1 to receive either HB0025 combined with chemotherapy (experimental group) or tislelizumab combined with chemotherapy (control group). Both regimens will be administered once every 3 weeks (Q3W). After completing 4 cycles of treatment, patients will enter the maintenance therapy phase with HB0025 or tislelizumab plus pemetrexed (Q3W). The treatment will last until the investigator determines that there is no longer clinical benefit (based on comprehensive assessment of RECIST v1.1 imaging results and clinical symptoms), intolerable toxicity occurs, 35 cycles of study treatment are completed, or other treatment termination criteria specified in the protocol are met, whichever comes first.

Participants needed: 500
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Feb 3, 2026Locations: 1
Eligibility criteria

Able to fully understand and voluntarily sign the informed consent form, and wil... [+15]

Histologically confirmed presence of any small cell carcinoma, neuroendocrine ca... [+35]

Status: Not yet recruiting

Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

This study is a randomized, controlled, double-blind, multi-center phase III registration clinical trial, aiming to observe, compare and evaluate the efficacy and safety of HB0025 combined with paclitaxel + carboplatin compared with pembrolizumab combined with paclitaxel + carboplatin as the first-line treatment for locally advanced or metastatic squamous NSCLC. The study subjects are patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received systemic anti-tumor treatment before. The study will use the PFS evaluated by BICR as the primary endpoint, and plan to enroll approximately 480 subjects, with the proportion of locally advanced subjects not exceeding 10%. The subjects were fully informed and signed the informed consent form. If they met the inclusion criteria but did not meet the exclusion criteria, they were randomly assigned in a 1:1 ratio to receive HB0025 combined with chemotherapy Paclitaxel plus Platinum (experimental group) or pembrolizumab combined with chemotherapy Paclitaxel plus Platinum (control group). Both were administered once every 3 weeks (Q3W). After 4 cycles of treatment, Enter HB0025 or pembrolizumab monotherapy maintenance treatment (Q3W) until the investigator determines that there is no longer any clinical benefit (based on the RECIST v1.1 imaging assessment and comprehensive clinical symptom assessment by the investigator), intolerable toxicity occurs, 24 months of study treatment is completed, or other treatment termination criteria in the protocol are met. Whichever occurs first shall prevail.

Participants needed: 480
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Jan 22, 2026Locations: 1
Eligibility criteria

Able to fully understand and voluntarily sign the informed consent form, and wil... [+9]

Histologically confirmed presence of any small cell carcinoma, neuroendocrine ca... [+27]

Status: Recruiting

Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

Participants needed: 15
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Jan 7, 2026Locations: 1
Eligibility criteria

HS lesions in at least 2 distinct anatomic area; [+2]

1. Participants with known hypersensitivity to HB0043 or any of its excipients;...

Status: Recruiting

A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.

Participants needed: 46
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Sep 8, 2025Locations: 1
Eligibility criteria

Healthy male or female subjects age ≥ 18 and ≤ 55 years. [+3]

History of clinically significant cardiovascular, respiratory, hepatic, renal, g... [+4]

Status: Recruiting

Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)

This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.

Participants needed: 33
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Mar 19, 2025Locations: 2
Eligibility criteria

A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of ≥... [+4]

Drug-triggered acute generalized exanthematous pustulosis (AGEP); [+11]

Status: Recruiting

Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis

This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).

Participants needed: 33
Trial details
Phase: Phase 2, Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Feb 14, 2025Locations: 3
Eligibility criteria

Patients participated in the preceding placebo-controlled Phase 2 study (HB0034-... [+3]

Patients who are experiencing GPP flare

Status: Recruiting

A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Jan 20, 2025Locations: 1
Eligibility criteria

Healthy male or female subjects age ≥ 18 and ≤ 55 years. [+2]

History of clinically significant opportunistic infection (e.g., invasive candid... [+2]

Status: Recruiting

A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors

It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors

Participants needed: 80
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.Updated: Jan 3, 2025Locations: 4
Eligibility criteria

Male or female. Age ≥ 18 years; [+11]

Concurrent malignancy < 5 years prior to entry other than adequately treated cer... [+24]