Clinical trials: sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Adults
A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults
This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study.
- Trial name
- NCT07473570
- Testing
- GS3-007a for Suspension
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- 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.
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.
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.
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.
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.
Safety, Tolerability
A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)
To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of…
- Conditions
- Safety, Tolerability, Adult Growth Hormone Deficiency
- Trial name
- NCT07016802
- Testing
- GenSci134, Recombinant Human Growth Hormone Injection (Norditropin®)
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hepatic Impairment and Healthy Female
GS1-144 in Participants With Hepatic Impairment and Healthy Female
GS1-144 in Participants with Hepatic Impairment and Healthy Female
- Trial name
- NCT07491289
- Testing
- GS1-144 tablet
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Bacterial Vaginosis
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
- Trial name
- NCT07302035
- Testing
- GenSci142
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Autoimmune Disease
A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci120 in Healthy Adults.
This study is designed to evaluate the safety, tolerability, PK and PD of GenSci120 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
- Trial name
- NCT06827457
- Testing
- GenSci120
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hyperprolactinemia
A Study on Bioequivalence of Cabergoline Tablets in Human Body
The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.
- Trial name
- NCT07008417
- Testing
- Cabergoline tablets test formulation, Cabergoline tablets reference formulation
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pediatric Growth Hormone Deficiency (PGHD)
A Bioequivalence Study of Two Different PEG-rhGH Preparations
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
- Trial name
- NCT06797505
- Testing
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (T)
- Where
- China
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Healthy Postmenopausal Women
A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women
To evaluate the pharmacokinetic (PK) characteristics of GS1-144 tablets and the relative bioavailability of the two preparations in healthy postmenopausal female subjects in China.
- Trial name
- NCT06983925
- Testing
- GS1-144 Tablet with new preparation (T), GS1-144 Tablet with present preparation (R)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Rheumatoid Arthritis
Assessment of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of GenSci120 in Healthy Adult Participants in China.
This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy…
- Trial name
- NCT07040930
- Testing
- GenSci120
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Vasomotor System; Labile, Healthy Volunteer
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population
A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a…
- Trial name
- NCT06385158
- Testing
- GS1-144 tablet
- Where
- China
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pediatric Growth Hormone Deficiency (PGHD)
A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
- Trial name
- NCT06135155
- Testing
- PEG-rhGH with new preparation, PEG-rhGH with present preparation
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pediatric Growth Hormone Deficiency (PGHD)
A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations after a single administration.
- Trial name
- NCT06135168
- Testing
- PEG-rhGH with new preparation, PEG-rhGH with present preparation
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pediatric Growth Hormone Deficiency (PGHD)
A Bioavailability Study of Two Different PEG-rhGH Preparations.
The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations.
- Trial name
- NCT06385145
- Testing
- PEG-rhGH with new preparation (T), PEG-rhGH with present preparation (R)
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.