Clinical trials: Pharmacodynamics
Parkinson's Disease
An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease
The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.
- Trial name
- NCT00918177
- Testing
- AP09004, Carbidopa/Levodopa, immediate release
- Where
- 7 sites in Israel
- Volunteers
- 72 people
- Sponsor
- Intec Pharma Ltd.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and a multiple ascending dose (repeat doses of mRNA-6231) part.
- Trial name
- NCT04916431
- Testing
- mRNA-6231
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Physiological Effects of Drugs, Neoplasms by Histologic Type
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.
- Conditions
- Physiological Effects of Drugs, Neoplasms by Histologic Type, Lymphoma, Hematologic Neoplasms
- Trial name
- NCT03722186
- Testing
- SHR-1603
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Colon Cancer
Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel cleansing solution (MOVIPREP®)
- Trial name
- NCT01714466
- Testing
- NER1006, MOVIPREP
- Where
- 2 sites in Germany
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Norgine
Obesity and Overweight
A Study of IBI3046 in Participants With Overweight or Obesity
This study evaluates the safety, tolerability, pharmacokinetics and pharmacodynamics of IBI3046 in Chinese overweight or obese participants, comprising four phases: single ascending dose (SAD), multiple ascending dose (MAD)…
- Trial name
- NCT07809945
- Testing
- IBI3046
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy Adult Participants
A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers
The purposes of this clinical study are 1. To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, and if there are any important side effects. 2.
- Trial name
- NCT07798505
- Testing
- HMB-003
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hemab ApS
Advanced Solid Tumor, Lymphoma
Open-label Study of DS-8273a to Assess Its Safety and Tolerability, and Assess Its Pharmacokinetic and Pharmacodynamic Properties in Subjects With Advanced Solid Tumors or Lymphomas
This will be a Phase 1, open-label study of DS-8273a to assess its safety and tolerability, identify the Maximum Tolerated Dose and/or Maximum Administered Dose, and assess its properties in subjects with advanced solid tumors or…
- Trial name
- NCT02076451
- Testing
- DS-8273a
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Daiichi Sankyo
Healthy
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect and DDI of Ascending Doses of the MEK Inhibitor Zapnometinib
The purpose of this study is to evaluate the safety and tolerability of ascending doses of the MEK-inhibitor zapnometinib (ATR-002) given as single doses (SAD Part) and as multiple doses for 7 days (MAD Part) in healthy subjects.
- Trial name
- NCT05555823
- Testing
- ATR-002, Repaglinide, Celecoxib
- Where
- Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Atriva Therapeutics GmbH
Primary Immune Thrombocytopenia
Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune…
- Trial name
- NCT06594146
- Testing
- CM313 injection
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Keymed Biosciences Co.Ltd
Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
- Conditions
- Secondary Hyperparathyroidism Due to Renal Causes, Chronic Kidney Diseases, Vitamin D Deficiency, Stage 5 Chronic Kidney Disease
- Trial name
- NCT03602261
- Testing
- Calcifediol Oral Capsule
- Where
- 18 sites in United States
- Volunteers
- 44 people
- Sponsor
- OPKO Health, Inc.
Major Depressive Disorder (MDD)
A Study to Evaluate the Effectiveness of DT-101 as an Adjunctive Treatment in Patients With Depression
In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression.
- Trial name
- AERON-1 (NCT07610473)
- Testing
- DT-101
- Where
- 23 sites in United States
- Volunteers
- 118 people
- Sponsor
- Draig Therapeutics Ltd
Covid19
Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients
This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single…
- Trial name
- NCT04941183
- Testing
- NTR-441
- Where
- 4 sites in Austria, Ukraine
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Neutrolis
Cardiometabolic Disease
Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
- Trial name
- NCT06585462
- Testing
- AMG 513
- Where
- 13 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy
Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 With Neulasta
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of…
- Trial name
- NCT02650973
- Testing
- CHS-1701, Pegfilgrastim
- Where
- 4 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Coherus Oncology, Inc.
Hypertension
A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension
- Trial name
- NCT07352969
- Testing
- IBI3016
- Where
- China
- Volunteers
- 352 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Gout
RDEA3170 and Allopurinol Combination Study in Gout Subjects
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in…
- Trial name
- NCT02279641
- Testing
- RDEA3170 10 mg, allopurinol 300 mg
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Ardea Biosciences, Inc.
COPD
Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects of QAX028 compared to tiotropium and…
- Trial name
- NCT00568503
- Testing
- QAX028, Tiotropium bromide
- Where
- Denmark
- Volunteers
- 29 people
- Sponsor
- Novartis
Lewy Body Disease, Parkinson Disease
A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
The purpose of study is to demonstrate the pharmacodynamic (PD) effects of E2027 on cerebrospinal fluid (CSF) cyclic guanosine monophosphate (cGMP) in participants with DLB and PDD with and without amyloid copathology after 9…
- Trial name
- NCT04764669
- Testing
- E2027
- Where
- 14 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Eisai Inc.
Healthy
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of Single- and Multiple-Ascending Doses of MH-001 in Healthy Volunteers
First-in-Human study to demonstrate the safety and tolerability of single- and multiple-ascending doses of MH-001 in Healthy Volunteers (HVs)
- Trial name
- NCT06780254
- Testing
- MH-001
- Where
- Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Vespina Lifesciences Inc.
Healthy
Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male…
- Trial name
- NCT01429688
- Testing
- Anplag
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Alvogen Korea
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