Clinical trials: Pharmacodynamics
Osteogenesis Imperfecta
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta
This is a randomized, open label intra-patient dose escalation study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of BPS804 in adults with osteogenesis imperfecta (OI).
- Trial name
- NCT01417091
- Testing
- BPS804
- Where
- 6 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Duchenne Muscular Dystrophy
Phase IIb Study of PRO045 in Subjects With Duchenne Muscular Dystrophy
The purpose of the study is to see whether PRO045 is safe and effective to use as medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 45 in the DNA for the dystrophin protein.
- Trial name
- NCT01826474
- Testing
- PRO045, 0.15 mg/kg/week, PRO045, 1.0 mg/kg/week, PRO045, 3.0 mg/kg/week
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Acute Cannabinoid Intoxication
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test
The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis.
- Trial name
- NCT05282797
- Testing
- ANEB-001
- Where
- Netherlands
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Anebulo Pharmaceuticals
Optic Neuritis, Optic; Neuritis, With Demyelination
BN201 SAD MAD Study in Healthy Subjects
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of BN201 in healthy subjects.
- Trial name
- NCT03630497
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Accure Therapeutics
Systemic Lupus Erythematosus
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- Trial name
- BLOSSOM (NCT05835310)
- Testing
- Anifrolumab
- Where
- 103 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Healthy
A Study to Evaluate the Safety and Tolerability of KJ103 in Healthy Adults
This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.
- Trial name
- NCT05274659
- Testing
- KJ103
- Where
- New Zealand
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
Healthy
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
- Trial name
- NCT01541488
- Testing
- BI 1021958
- Where
- Germany
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Overweight, Healthy Volunteers
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
- Trial name
- NCT05096598
- Testing
- ZP8396
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Advanced Malignancies
Safety Study of Oral MGCD265 Administered With Interruption to Subjects With Advanced Malignancies
In this study, MGCD265, a new anticancer drug under investigation, is given daily on a 7 days on / 7 days off schedule to patients with advanced malignancies to study its safety profile.
- Trial name
- NCT00679133
- Testing
- MGCD265
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mirati Therapeutics Inc.
Advanced Solid Tumor
A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor
This study is a phase I/II study of single drug TJ011133 and Toripalimab combine treatment forAdvanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension.
- Trial name
- NCT05148533
- Testing
- TJ1133 Injection
- Where
- 22 sites in China
- Volunteers
- 7 people
- Sponsor
- TJ Biopharma Co., Ltd.
Hypertension
The PK/PD Study of SHR0532 Tablets in Healthy Subjects
In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis.
- Trial name
- NCT03645278
- Testing
- SHR0532
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Neoplasms
A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)
This is a 2 part study. Part 1 is a dose escalation to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) dose of MK-0482 administered as monotherapy and in combination with…
- Trial name
- NCT03918278
- Testing
- MK-0482, pembrolizumab, Paclitaxel
- Where
- 16 sites in United States, Australia and 6 more
- Volunteers
- 222 people
- Sponsor
- Merck Sharp & Dohme LLC
Pulmonary Disease, Chronic Obstructive
Succinate Salt Version of GSK961081 for Healthy Volunteers
Salt Bridging study for GSK961081
- Trial name
- NCT00550225
- Testing
- GSK961081
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Healthy
Safety, Pharmacokinetics and Pharmacodynamics of the Two Esomeprazole Formulations
This study is a Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1601 (40 mg or 20 mg) to HGP1705 (40 mg or 20 mg) After Multiple Administrations in Healthy…
- Trial name
- NCT03372850
- Testing
- HIP1601, HGP1705
- Where
- South Korea
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Healthy
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone
This study is to evaluate the safety/tolerability and pharmacokinetics/pharmacodynamics of the combinations of gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component administered in healthy…
- Trial name
- NCT01662674
- Testing
- gemigliptin and metformin HCl extended release, gemigliptin/metformin HCl extended release
- Where
- South Korea
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Hypercholesterolemia, Healthy Volunteers
A Study on Evaluating the Safety of HST101 in Healthy Chinese Participants
This is a single-center, randomized, double-blind, placebo-controlled, single HST101 SC dose cohort study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Chinese Participants with Elevated…
- Conditions
- Hypercholesterolemia, Healthy Volunteers, LDL-Cholesterol
- Trial name
- NCT06504043
- Testing
- HST101
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hasten Biopharmaceutical Co., Ltd.
Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
- Conditions
- Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy, IgA Nephropathy
- Trial name
- NCT03719443
- Testing
- VIS649
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Type 2 Diabetes Mellitus
A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)
A five-period crossover study to assess and compare the trough dipeptidyl peptidase IV (DPP-4) inhibition at 24-hours following the final morning dose for sitagliptin, saxagliptin and vildagliptin after 5 days of once daily…
- Trial name
- NCT01582308
- Testing
- Sitagliptin 100 mg, Saxagliptin 5 mg, Vildagliptin 50 mg
- Volunteers
- 22 people
- Sponsor
- Merck Sharp & Dohme LLC
Treatment of Pain
A First-in-human Trial of GRT7041 in Healthy Participants
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GRT7041 in healthy male and female (Women of non-childbearing potential) participants.
- Trial name
- NCT07289776
- Testing
- GRT7041 SAD, Midazolam, GRT7041 MAD
- Where
- New Zealand
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Drug Safety and Bioavailability
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
This study will have one stage consisting of multiple treatment visits. The study is designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy volunteers in various formulation.
- Trial name
- NCT02571140
- Testing
- Teriparatide, Oral PTH (1-34)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Entera Bio Ltd.
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