Clinical trials: Pharmacodynamics
Vulvar Atrophy
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.
- Trial name
- DARE-VVA1 (NCT05378269)
- Testing
- Tamoxifen
- Where
- 2 sites in Australia
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Healthy
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants
The purpose of this study is to assess safety and tolerability of day-time and night-time dosing of JNJ-55375515 in healthy male participants.
- Trial name
- NCT03405441
- Testing
- JNJ-55375515 Dose Level 1, JNJ-55375515 Dose Level 2, JNJ-55375515 Dose Level 3
- Where
- Netherlands
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Subjects
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants
The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese…
- Trial name
- NCT06308523
- Testing
- AP303 150 μg, AP303 300 μg
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alebund Pharmaceuticals
Type 2 Diabetes
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of ALT-801 and its effects on glucose control in…
- Trial name
- NCT05134662
- Testing
- ALT-801
- Where
- 7 sites in United States
- Volunteers
- 55 people
- Sponsor
- Altimmune, Inc.
Stroke
The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers
Double blind, randomized, placebo control, multiple dose, dose escalation study
- Trial name
- NCT02396069
- Testing
- JPI-289
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
Healthy Subjects
Study Evaluating the Safety and Pharmacokinetics of Ascending Single IV Doses of ERB-257
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of ERB-257 in healthy subjects
- Trial name
- NCT00722501
- Testing
- ERB-257
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects
This study will evaluate the safety and tolerability of ascending single oral doses of AHT956 in healthy subjects
- Trial name
- NCT00410228
- Testing
- AHT956
- Where
- Switzerland
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis
Chronic Weight Management
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Combination With Semaglutide
This will be a phase I, randomized, double-blind, placebo-controlled. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
- Trial name
- NCT06972992
- Testing
- ASC47 +Semaglutide
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Type 1 Diabetes Mellitus
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.
- Trial name
- NCT03512236
- Testing
- BC Pram Ins, Symlin® and Humulin®, Humalog®
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Adocia
Healthy Adult Volunteers
A Multiple Dose Study of DWP05195 in Healthy Adult Subjects
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple administered DWP05195 in healthy volunteers
- Trial name
- NCT01094834
- Testing
- DWP05195
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Anemia of Chronic Kidney Disease
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal…
- Trial name
- NCT01971164
- Testing
- JTZ-951
- Where
- 5 sites in United States
- Volunteers
- 29 people
- Sponsor
- Shionogi Inc.
Mild Dyslipidemia
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.
- Trial name
- NCT01105598
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Esperion Therapeutics, Inc.
Non-cystic Fibrosis Bronchiectasis
A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation
This study is open to adults with non-cystic fibrosis bronchiectasis. The main purpose of this study is to find out how a medicine called BI 1323495 is tolerated by people with non-cystic bronchiectasis.
- Trial name
- NCT04656275
- Testing
- BI 1323495
- Where
- 3 sites in Germany
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Advanced Malignant Tumors
JSKN033 in Chinese Subjects with Advanced Malignant Tumors
This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.
- Trial name
- NCT06770881
- Testing
- JSKN033
- Volunteers
- 430 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Healthy Volunteers
A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants
The primary objective of this study is to evaluate the safety and tolerability of E2086 following administration of a single oral doses in healthy adult and elderly participants.
- Trial name
- NCT05745207
- Testing
- E2086
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Rheumatoid Arthritis
A Study of the Pharmacokinetics and Safety of SM03 in Patients With Rheumatoid Arthritis
This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
- Trial name
- NCT04704492
- Testing
- Biological: SM03
- Where
- China
- Volunteers
- 8 people
- Sponsor
- SinoMab BioScience Ltd
Healthy
AZD8848 Single Ascending Dose Study
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of AZD8848 in healthy subjects.
- Trial name
- NCT01560234
- Testing
- AZD8848
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bone Metastases
Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.
- Trial name
- NCT04812509
- Testing
- MW032, Xgeva
- Where
- China
- Volunteers
- 708 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Diabetes Mellitus, Type 2
A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of JNJ-28431754 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetic characteristics of JNJ-28431754 after multiple dosing in patients with Type 2 Diabetes Mellitus who are on a stable…
- Trial name
- NCT01177163
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hepatitis B
Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets
To Evaluate the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets in Multiple-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Multiple-administration Study in Patients With Chronic…
- Trial name
- NCT04868981
- Testing
- GST-HG141 tablets
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fujian Cosunter Pharmaceutical Co. Ltd
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