Clinical trials: sponsored by Haisco Pharmaceutical Group Co., Ltd.
IgA Nephropathy (IgAN)
Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
- Trial name
- NCT07390123
- Testing
- HSK39297
- Where
- 9 sites in China
- Volunteers
- 370 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
IgA Nephropathy (IgAN)
Phase II Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
- Trial name
- NCT06670352
- Testing
- HSK39297 50mgBID, HSK39297 100mgBID, HSK39297 200mgQD
- Where
- 2 sites in China
- Volunteers
- 87 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Pain After Surgery
A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery
This is a multi-center, randomized, double-blind, double-dummy, placebo/active-controlled study. 200 subjects undergoing abdominal surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718…
- Trial name
- NCT07533786
- Testing
- HSK55718 dose level1, HSK55718 dose level2, HSK55718 dose level 3
- Where
- 2 sites in China
- Volunteers
- 200 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Solid Tumors (Phase 1)
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid…
- Trial name
- NCT07561554
- Testing
- HSK42360-Na
- Where
- 2 sites in China
- Volunteers
- 159 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy
Bioequivalence Study of Tenofovir Disoproxil Fumarate Tablets in Healthy Chinese Subjects
This study evaluated the bioequivalence and safety of the test formulation (Tenofovir Disoproxil Fumarate Tablets, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (Viread®, Gilead Sciences, Inc.) in healthy…
- Trial name
- NCT07558967
- Testing
- Test Tenofovir Disoproxil Fumarate Tablets, Reference Tenofovir Disoproxil Fumarate Tablets（Viread®）
- Where
- China
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy
Bioequivalence Study of Lidocaine and Prilocaine Cream in Healthy Chinese Subjects
The test formulation (Lidocaine and Prilocaine Cream, Haisco Pharmaceutical Group Co., Ltd.) and the reference formulation (EMLA®, AstraZeneca) were applied to healthy adult subjects under fasting conditions to evaluate the…
- Trial name
- NCT07551713
- Testing
- Tested Lidocaine and Prilocaine Cream, Reference Lidocaine and Prilocaine Cream (EMLA®)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Pain After Surgery
A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine…
- Trial name
- NCT07551739
- Testing
- HSK55718 dose level 1, HSK55718 dose level 2, HSK55718 dose level 3
- Volunteers
- 200 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy
Bioequivalence Study of Pramipexole Dihydrochloride Extended-release Tablets in Healthy Chinese Subjects
The study compared pramipexole dihydrochloride extended-release tablets (Test formulation) by Haisco Pharmaceutical Group Co., Ltd.
- Trial name
- NCT07519278
- Testing
- Test formulation（pramipexole dihydrochloride extended-release tablets）, Reference formulation（MIRAPEX ER®）
- Where
- China
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Idiopathic Pulmonary Fibrosis
Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosis
This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
- Trial name
- IPF (NCT06764862)
- Testing
- HSK44459 dose 1, HSK44459 dose 2, HSK44459 dose 3
- Where
- China
- Volunteers
- 186 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
IPF
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis
This study aims to evaluate the efficacy and safety of HSK44459 tablets in patients with idiopathic pulmonary fibrosis (IPF).
- Trial name
- NCT07519070
- Testing
- HSK44459
- Volunteers
- 420 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healhty
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.
This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects
- Trial name
- NCT07521345
- Testing
- HSK55879
- Where
- China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Chronic Obstructive Pulmonary Disease (COPD)
Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)
To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler compared with the placebo in the treatment of Chinese patients with COPD.
- Trial name
- NCT07108699
- Testing
- HSK39004 Dry Powder Inhaler-0.75mg, HSK39004 Dry Powder Inhaler-1.5mg, HSK39004 Dry Powder Inhaler Simulant
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients With COPD
To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD
- Trial name
- NCT06643078
- Testing
- HL231 Solution for Inhalation, Ultibro 110μg/50 μg
- Where
- 2 sites in China
- Volunteers
- 487 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
General Anesthetic
HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery
This multicenter, randomized, double-blinded, propofol-controlled Phase 3b study enrolls pediatric subjects aged 3-17 years undergoing elective surgery with endotracheal intubation.
- Trial name
- NCT07510945
- Testing
- HSK3486, propofol
- Volunteers
- 400 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Progressive Pulmonary Fibrosis
Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis
This study is open to adults with PPF . The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
- Trial name
- PPF (NCT07503587)
- Testing
- HSK44459
- Volunteers
- 378 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Ulcerative Colitis (UC)
A Study for HSK47388 in Participants With Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .
- Trial name
- NCT07335055
- Testing
- HSK47388
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Chronic Obstructive Lung Disease (COLD)
Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD
This clinical trial evaluates the long-term safety and efficacy of 0.75 mg HSK39004 Dry Powder Inhaler administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive…
- Trial name
- NCT07425210
- Testing
- HSK39004 Dry Powder Inhaler -0.75mg BID
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Paroxysmal Nocturnal Haemoglobinuria (PNH)
Efficacy and Safety of HSK39297 in Anti-C5 Treated PNH Patients With Anemia
The purpose of this study is to evaluate the efficacy of HSK39297 tablets in paroxysmal nocturnal hemoglobinuria (PNH) patients with anemia after stable treatment of anti-C5 antibody.
- Trial name
- NCT07052838
- Testing
- HSK39297 tablets
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Lupus Nephritis (LN)
Study to Assess Efficacy and Safety of HSK39297 Tablets in Patients With LN
A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
- Trial name
- NCT07363460
- Testing
- HSK39297 200mgQD, HSK39297 300mgQD
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
COPD Patients
A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients
This is a random, single blind, positive control, crossover design clinical study to evaluate the pharmacokinetics and pharmacodynamics of HSK39004 inhalation suspension in COPD patients
- Trial name
- NCT07331402
- Testing
- HSK39004 inhalation suspension
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.