Clinical trials: sponsored by Haisco Pharmaceutical Group Co., Ltd.
Advanced Solid Tumor (Phase 1)
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors
This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors.
- Trial name
- NCT07695142
- Testing
- HSK46256
- Where
- China
- Volunteers
- 275 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Postoperative Pain Management
A Phase 2 Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine…
- Trial name
- NCT07442877
- Testing
- HSK21542 dose level 1, HSK21542 dose level 2, morphine
- Where
- 27 sites in China
- Volunteers
- 161 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
- Trial name
- NCT07581951
- Testing
- HSK31679
- Where
- China
- Volunteers
- 886 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Metastatic Colorectal Cancer (CRC)
HSK42360-Na Tablets Combined With Cetuximab With or Without Chemotherapy in BRAF V600-Mutant Metastatic Colorectal Cancer
This is a Phase I/II, single-arm, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HSK42360-Na tablets combined with cetuximab with or without chemotherapy in…
- Trial name
- NCT07790510
- Testing
- HSK42360-Na Tablets, Cetuximab (EGFR inhibitor), mFOLFOX6 Regimen (Oxaliplatin/Leucovorin/5-FU)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Postoperative Pain Management
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery
This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine…
- Trial name
- NCT07186426
- Testing
- HSK21542, morphine
- Where
- 2 sites in China
- Volunteers
- 405 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Idiopathic Pulmonary Fibrosis (IPF)
Evaluating the Efficacy and Safety of of HSK50042 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 (NCT07728721)
- Testing
- HSK50042 dose 1, HSK50042 dose 2, HSK50042 dose 3
- Volunteers
- 175 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC)
HSK41959 With Standard Therapy in Solid Tumors With MTAP Deletion
This is a Phase Ib, open-label, multicenter study of HSK41959 tablets in combination with standard therapy in patients with MTAP-deficient advanced solid tumors.
- Conditions
- Non-Small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma (mPDAC), Advanced Solid Tumors
- Trial name
- NCT07699757
- Testing
- HSK41959, Sintilimab, Pemetrexed + Cisplatin /Carboplatin
- Where
- China
- Volunteers
- 258 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Healthy Volunteer
First-in-human Study of HSK56630 in Healthy Subjects
This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630…
- Trial name
- NCT07580794
- Testing
- HSK56630
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Non-Alcoholic Steatohepatitis (NASH)
To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) .
A double-blind placebo controlled, randomized, Phase 2b study to evaluate the efficacy and safety of once-daily, oral administration of 80 or 160 mg HSK31679 versus matching placebo in Patients With Non-Alcoholic Steatohepatitis…
- Trial name
- NCT06168383
- Testing
- HSK31679 80mg, HSK31679 160mg
- Where
- China
- Volunteers
- 186 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
COPD (Chronic Obstructive Pulmonary Disease)
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD
The purpose of this study is to evaluate the efficacy and safety of HSK39004 Inhalation Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- NCT07658339
- Testing
- HSK39004 Inhalation Suspension
- Where
- China
- Volunteers
- 387 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
COPD (Chronic Obstructive Pulmonary Disease)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD
To evaluate the efficacy and safety of a 12-week administration of HSK39004 inhalation powder in clinical trial participants with COPD
- Trial name
- NCT07583849
- Testing
- HSK39004 Dry Powder Inhaler Simulant, HSK39004 Dry Powder Inhaler-0.75mg
- Where
- China
- Volunteers
- 376 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Chronic Obstructive Lung Disease (COLD)
Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD)
To evaluate the safety and efficacy of the HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension compared with the placebo in the treatment of Chinese patients with COPD.
- Trial name
- NCT07140328
- Testing
- HSK39004 Dry Powder Inhaler -0.75mg BID, HSK39004 Dry Powder Inhaler -1.5mg BID, HSK39004 Inhalation Suspension -3mg BID
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
COPD (Chronic Obstructive Pulmonary Disease)
Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD
This clinical trial evaluates the long-term safety and efficacy of 3 mg HSK39004 Inhalation Suspension administered twice daily for 52 weeks in subjects aged 40 to 80 years with moderate-to-severe stable chronic obstructive…
- Trial name
- NCT07634367
- Testing
- HSK39004 Inhalation Suspension
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Psoriasis
Trial of HSK44459 Cream for the Management Plaque Psoriasis
Phase I Study Objectives: Primary: Assess the safety and tolerability of HSK44459 cream in 10 healthy adult participants and 10 patients with plaque psoriasis.
- Trial name
- NCT07623486
- Testing
- HSK44459 Cream, Vehicle
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Non-cystic Fibrosis Bronchiectasis
A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
- Trial name
- NCT07616375
- Testing
- HSK31858, tablet
- Where
- China
- Volunteers
- 669 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
IgA Nephropathy (IgAN)
A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD…
- Trial name
- NCT07616700
- Testing
- HSK39297 200mgQD, HSK39297 300mgQD
- Where
- 2 sites in China
- Volunteers
- 73 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.
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.
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.