Clinical trials: sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Autoimmune Disease
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.
This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
- Trial name
- NCT07366866
- Testing
- GenSci136
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Small for Gestational Age
A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)
This is a multicenter, randomized, open-label, active-controlled Phase III clinical study to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of once-weekly PEG-hGH injection compared with once-daily hGH…
- Trial name
- NCT07841678
- Testing
- PEG-hGH Injection, hGH Injection
- Where
- China
- Volunteers
- 105 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Locally Advanced or Metastatic Solid Tumors With PIK3CA-mutated
GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.
An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with…
- Trial name
- NCT07407504
- Testing
- GenSci145 tablets
- Where
- China
- Volunteers
- 186 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Postmenopause
To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets .
A Drug-Drug Interaction Study to Evaluate the Effect of Smoking (CYP1A2 Inducer) on the Pharmacokinetics Following a Single Oral Dose of GS1-144 Tablets in Chinese Healthy Postmenopausal Female Trial Participants
- Trial name
- NCT07534176
- Testing
- GS1-144 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Active Systemic Juvenile Idiopathic Arthritis
To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis.
A multicenter, randomized Phase II/III clinical study to evaluate the efficacy and safety of GenaKumab in the treatment of active systemic juvenile idiopathic arthritis.
- Trial name
- NCT05925452
- Testing
- GenaKumab
- Where
- 10 sites in China
- Volunteers
- 290 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pediatric Growth Hormone Deficiency
A Study (Phase 1b/2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD)
This is a two-part clinical study for children with growth hormone deficiency. In the first part, participants will be randomly assigned to receive different doses of an oral treatment (GS3-007a dry suspension) or a placebo for…
- Trial name
- NCT07264595
- Testing
- GS3-007a dry suspension, rhGH injection
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME)
A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion
This is a Phase I, multicenter, open-label, dose-escalation study conducted in two parts to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GenSci148 administered via intravitreal (IVT)…
- Conditions
- Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)
- Trial name
- GenSci148-101 (NCT07817615)
- Testing
- GenSci148 Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Adult Trial Participants
Phase 1 Clinical Study of GenSci164 Injection
This is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation Phase 1 clinical study to evaluate the safety, tolerability, PK profile, PD profile, and immunogenicity of GenSci164 after a single…
- Trial name
- NCT07790783
- Testing
- GenSci164 Injection
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Achondroplasia
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
- Trial name
- NCT05353192
- Testing
- Recombinant human growth hormone
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Uveitis
A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.
This study is designed to evaluate the efficacy and safety of GenSci048 compared with placebo in subjects with active non-infectious uveitis.
- Trial name
- NCT07547995
- Testing
- GenSci048
- Where
- China
- Volunteers
- 74 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Short Bowel Syndrome (SBS) in Adults
Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
This is a multicenter, open-label, single-arm clinical trial. A total of 100 participants with short bowel syndrome (SBS) receiving parenteral nutrition (PN) support are planned to be enrolled.
- Trial name
- NCT07691125
- Testing
- rhGH injection
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Phenylketonuria
GenSci144 Tablets Phase I Clinical Trial
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels.
- Trial name
- NCT07685210
- Testing
- GenSci144 tablets
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Adult Trial Participants
Phase 1 Clinical Study of GenSci155 Injection in Healthy Adults
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single and multiple intravenous ascending dose clinical study to evaluate the safety, tolerability, PK, immunogenicity, and biomarker characteristics…
- Trial name
- NCT07638800
- Testing
- GenSci155 Injection
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Adult Growth Hormone Deficiency (AGHD)
A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)
The GS3-007a Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, three-way crossover trial.
- Trial name
- NCT07259564
- Testing
- GS3-007a dry suspension, Insulin
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Advanced Gastric or Gastroesophageal Junction Cancer
A Study of Gentuximab + Paclitaxel in Patients With Advanced Gastric or Gastroesophageal Junction Cancer
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to…
- Trial name
- NCT04053205
- Testing
- Gentuximab, Paclitaxel
- Where
- 12 sites in China
- Volunteers
- 76 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Rheumatoid Arthritis
Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have an Inadequate Response to at Least One DMARD
This is a multicenter, randomized, double-blind, parallel, placebo- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD…
- Trial name
- NCT07423533
- Testing
- GenSci120 150 mg, GenSci120 600 mg, GenSci120 1000 mg
- Where
- China
- Volunteers
- 450 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Postmenopausal Women, Absorption
A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Female Participants
This is a single-center, non-randomized, open-label, single-dose clinical PK study in healthy postmenopausal female participants.
- Conditions
- Healthy Postmenopausal Women, Absorption, Metabolism, Excretion
- Trial name
- NCT07537231
- Testing
- [14C]GS1-144
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants
To Evaluate the Safety and Tolerability, Pharmacokinetics and Biomarker of GenSci161 in a Randomized, Double-blind, Placebo-controlled Study in Healthy Adult Participants.
- Trial name
- NCT07476586
- Testing
- GenSci161
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Vasomotor Syndrome
Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal Women.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of GS1-144 Tablets in the Treatment of Moderate to Severe Vasomotor Symptoms in Chinese Postmenopausal…
- Trial name
- NCT06726850
- Testing
- GS1-144
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.