Clinical trials: PK, PD, and Safety
PK in Healthy Volunteers
A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
The goal of this study type: PK clinical trial is to evaluate the safety, tolerability, and pharmacokinetics/ pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers.
- Trial name
- P2203 phase I (NCT06698861)
- Testing
- PEG-MetHuG-CSF, Neulasta (Amgen)
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- PharmaEssentia
Type 2 Diabetes Mellitus
A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT01044537
- Testing
- PF-04937319
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Pfizer
Healthy Volunteers
Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.
- Trial name
- NCT01262794
- Testing
- CDP6038
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
DLBCL
A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects
This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in…
- Trial name
- NCT01205737
- Testing
- TL011, Rituximab
- Where
- 41 sites in Bulgaria, Estonia and 8 more
- Volunteers
- 186 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Alzheimer Disease
A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease
The purpose of this study is to measure effects on CSF biomarkers, EEG and safety with REM0046127 oral suspension compared with placebo in subjects with mild to moderate Alzheimer disease.
- Trial name
- NCT05478031
- Testing
- REM0046127 High Dose, REM0046127 Low Dose
- Where
- 3 sites in Netherlands, Spain
- Volunteers
- 14 people
- Sponsor
- reMYND
Non-alcoholic Fatty Liver Disease
Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH
The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated.
- Trial name
- SKYLINE (NCT06104319)
- Testing
- GSK4532990
- Where
- 14 sites in United States
- Volunteers
- 61 people
- Sponsor
- GlaxoSmithKline
Male, Hemophilia A With Inhibitor
SS109 and NovoSeven ® PK / PD Profile, and Preliminary Efficacy and Safety of SS109 on Demand Treatment
This is an open-label, multicenter Phase 1Ib/2II clinical trial of SS109 in adult hemophilia patients (≥ 18 years) with FVIII or FIX inhibitors to evaluate the PK/PD profile of SS109 and NovoSeven® after a single dose in adult…
- Conditions
- Male, Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Hemophilia
- Trial name
- NCT06010953
- Testing
- SS109
- Where
- 9 sites in China
- Volunteers
- 24 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Healthy Subjects
Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in Adults
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic characteristics of Singletine in healthy adult subjects.
- Trial name
- NCT06160401
- Testing
- Singletine
- Where
- China
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Guangzhou JOYO Pharma Co., Ltd
Malignant Ascites, Cancer
A Study of M701 (EpCAM and CD3) in Malignant Ascites
This study is to investigate the safety, tolerability, PK, PD and immunogenicity of multiple ascending doses of M701 administered intraperitoneally to patients with malignant ascites caused by advanced solid tumors.
- Trial name
- NCT04501744
- Testing
- Cohort 1 of M701, Cohort 2 of M701, Cohort 3 of M701
- Where
- 2 sites in China
- Volunteers
- 35 people
- Sponsor
- Wuhan YZY Biopharma Co., Ltd.
Relapsing Multiple Sclerosis
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R).
- Trial name
- NCT06847724
- Testing
- CYB704, Ocrevus-EU, Ocrevus-US
- Where
- 41 sites in United States, Bosnia and Herzegovina and 6 more
- Volunteers
- 183 people
- Sponsor
- Sandoz
Osteonecrosis, Osteonecrosis of the Femoral Head
A Phase II Trial of RAB001 (LLP2A-Alendronate) for Steroid-Induced Early-Stage Osteonecrosis of the Femoral Head
This is a multicenter, randomized (similar to drawing lots, where the treatment you receive is not chosen by you or the researchers), controlled, blinded (the three dose groups of the investigational drug are blinded, meaning…
- Trial name
- LLP2A-Ale (NCT07471880)
- Testing
- RAB001 high dose, RAB001 medium dose, RAB001 low dose
- Where
- China
- Volunteers
- 161 people
- Sponsor
- ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Safety, PK and PD Relationships of RLS-0071 in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
AECOPD is a major cause of hospital admission and mortality. They contribute to long-term decline in lung function, physical capacity, and quality of life (QoL).
- Trial name
- NCT06175065
- Testing
- RLS-0071
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- ReAlta Life Sciences, Inc.
Healthy
Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and…
- Trial name
- NCT01208753
- Testing
- GLPG0555, GLPG0555 aqueous
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
The purpose of this study is to assess the safety, tolerability and efficacy of emapalumab in children and adults with macrophage activation syndrome (sHLH/MAS) in Still's disease (including systemic juvenile idiopathic arthritis…
- Conditions
- Macrophage Activation Syndrome, Secondary Hemophagocytic Lymphohistiocytosis, Still Disease, Systemic Lupus Erythematosus
- Trial name
- EMERALD (NCT05001737)
- Testing
- Emapalumab
- Where
- 44 sites in United States, Belgium and 11 more
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Remimazolam, Pharmacokinetics and Pharmacodynamics
Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult…
- Trial name
- NCT07675850
- Testing
- Eleveld model-guided dosing, Standard weight-based label dosing
- Where
- South Korea
- Volunteers
- 68 people
- Sponsor
- Seoul National University Hospital
Healthy Volunteers
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses.
- Trial name
- NCT03551730
- Testing
- PRT064445/Enoxaparin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Chronic Hepatitis C Virus Infection, Genotype 1
A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C
The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics…
- Conditions
- Chronic Hepatitis C Virus Infection, Genotype 1, Treatment-Experienced Patients, Relapses
- Trial name
- NCT01121731
- Testing
- Interferon α-5, Interferon-α5 plus Interferon-α 2b, Interferon α-2b (INTRON® A)
- Where
- 15 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Digna Biotech S.L.
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB)
A Phase I Study Evaluating Safety, Tolerability, PK and PD of BL-8040 for Stem Cell Mobilization in Healthy Volunteers
The purpose of this study is to determine whether BL-8040 is safe, tolerable and effective in the mobilization of Hematopoietic Stem Cells (HSC) in healthy volunteers
- Trial name
- NCT02073019
- Testing
- BL-8040
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- BioLineRx, Ltd.
Postmenopausal Women With Osteoporosis
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.
This was a randomized, double-blind, parallel, multicenter, multinational study to compare the efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity of MB09 versus Prolia® in postmenopausal women with…
- Trial name
- NCT05338086
- Testing
- MB09 (denosumab biosimilar), EU-Prolia, Elemental Calcium
- Where
- 64 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 558 people
- Sponsor
- mAbxience Research S.L.
Parkinson's Disease
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC364 Injectable Suspension
This is a non-randomized, dose-escalation first-in-human study to evaluate the safety, tolerability, PK, and PD of HNC364 following intramuscular administration of single ascending doses.
- Trial name
- NCT05523570
- Testing
- HNC364
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.