Clinical trials: Pharmacodynamics
Asthma
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
This study is a randomized, double-blind, placebo-controlled, three-period cross-over study in approximately 54 subjects with asthma.
- Trial name
- NCT03257995
- Testing
- Indacaterol maleate, Indacaterol acetate
- Where
- 6 sites in United States
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Pharmacokinetic Interactions of Bisoprolol and Rosuvastatin
This study is designated to evaluate the pharmacokinetic interactions of bisoprolol and rosuvastatin in healthy male volunteers.
- Trial name
- NCT01925300
- Testing
- Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab, Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab, Concor 5mg 2T and Crestor 20 mg 1Tab
- Volunteers
- healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
- Trial name
- NCT07900945
- Testing
- CM551
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Acute Pain
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV) acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates and infants (age < 2 years) compared to placebo…
- Trial name
- NCT01635101
- Testing
- IV Acetaminophen, IV Control
- Where
- 22 sites in United States
- Volunteers
- 197 people
- Sponsor
- Mallinckrodt
Diabetes Mellitus
Pharmacokinetic (PK), Pharmacodynamic (PD), and Safety Study of Subcutaneously Administered Humalog® With and Without Recombinant Human Hyaluronidase (rHuPH20)and Humulin-R® With and Without rHuPH20
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units…
- Trial name
- NCT00705536
- Testing
- Humalog, Humulin-R, Recombinant human hyaluronidase PH20 (rHuPH20)
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Halozyme Therapeutics
Spinocerebellar Ataxia Type 2
Study of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2
Adult participants with spinocerebellar ataxia type 2 (SCA2) who carry ≥33 cytosine, adenine, guanine (CAG) repeats in the ATXN2 gene, and who have met all protocol eligibility criteria will be randomized to receive a single dose…
- Trial name
- NCT06672445
- Testing
- ARO-ATXN2 Injection
- Where
- 16 sites in Australia, Canada and 6 more
- Volunteers
- 39 people
- Sponsor
- Arrowhead Pharmaceuticals
Alzheimer's Disease
A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease
The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.
- Trial name
- NCT00945672
- Testing
- PF-04360365 10 mg/kg, PF-04360365 7.5 mg/kg
- Where
- 4 sites in Sweden
- Volunteers
- 36 people
- Sponsor
- Pfizer
Non-Alcoholic Fatty Liver Disease (NAFLD)
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD.
- Trial name
- NCT03776175
- Testing
- PF-05221304 Monotherapy, PF-06865571 Monotherapy, PF-05221304 and PF-06865571 Combination
- Where
- 29 sites in United States
- Volunteers
- 99 people
- Sponsor
- Pfizer
Healthy
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of…
- Trial name
- NCT01688830
- Testing
- Dabigatran, BI 655075
- Where
- Belgium
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin
PER977 administration following a single dose of enoxaparin
- Trial name
- PER977 (NCT02206100)
- Testing
- PER977, enoxaparin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Systemic Lupus Erythematosus
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN).
- Trial name
- NCT06984341
- Testing
- P-CD19CD20-ALLO1 Cells, Cyclophosphamide, Fludarabine
- Where
- 2 sites in United States
- Sponsor
- Genentech, Inc.
X-linked Hypophosphatemia
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
The objectives of the study are to: Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants Establish the safety profile of burosumab for the treatment of…
- Trial name
- NCT02163577
- Testing
- burosumab
- Where
- 9 sites in United States, France and 2 more
- Volunteers
- 52 people
- Sponsor
- Kyowa Kirin, Inc.
Advanced Cancer, Gastric Cancer
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors
A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors
- Conditions
- Advanced Cancer, Gastric Cancer, Breast Cancer, Pancreatic Cancer
- Trial name
- Minnelide 101 (NCT03129139)
- Testing
- Minnelide™Capsules
- Where
- 7 sites in United States
- Volunteers
- 66 people
- Sponsor
- Minneamrita Therapeutics LLC
Tumors
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.
- Trial name
- IMGN853-0401 (NCT01609556)
- Testing
- Mirvetuximab soravtansine
- Where
- 12 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- ImmunoGen, Inc.
Obesity, Type 2 Diabetes Mellitus
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults
XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.
- Trial name
- NCT05184322
- Testing
- T2026, Oral ecnoglutide tablet
- Where
- Australia
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Sciwind Biosciences APAC CO Pty. Ltd.
Healthy
First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-121 in Healthy Subjects
This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific…
- Trial name
- NCT03103451
- Testing
- BCD-121
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Subjects, Osteoarthritis
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy
The purpose of this study is to evaluate the safety and tolerbility of ascending multiple oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.
- Trial name
- NCT00380900
- Testing
- AGG-523
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Volunteers (HV)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers
Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.
- Trial name
- NCT07618156
- Testing
- KR25102 for Injection
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
Postmenopausal Women With Osteoporosis
Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
This study was conducted to assess if there were any clinically meaningful differences in pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, or immunogenicity between GP2411 (proposed biosimilar denosumab) and…
- Trial name
- NCT03974100
- Testing
- GP2411, EU-Prolia (EU-authorized Prolia®)
- Where
- 42 sites in United States, Bulgaria and 4 more
- Volunteers
- 527 people
- Sponsor
- Sandoz
Inflammation, Rheumatic Diseases
Phase 1 Study With KIN-1901 in Healthy Subjects and Subjects With Ankylosing Spondylitis
This study is intended to treat ankylosing spondylitis (AS). AS is a form of arthritis that primarily affects the spine. It is characterized by inflammation of the spinal joints that can lead to severe pain, and in more advanced…
- Trial name
- NCT04205851
- Testing
- KIN-1901
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Kinevant Sciences GmbH
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