Clinical trials: Pharmacokinetics and Pharmacodynamics
Malignant Pleural Effusion
A Phase I Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
A Phase I, Open, Multicenter Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion
- Trial name
- NCT05923515
- Testing
- JMKX000197
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Jemincare
Cerebral Hemorrhage
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH).
- Trial name
- NCT00029315
- Testing
- Recombinant Tissue Plasminogen Activator (rt-PA)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Johns Hopkins University
Developmental and/or Epileptic Encephalopathies
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to characterize the multiple-dose safety and tolerability profile of TAK-935 in adult participants with developmental and/or epileptic encephalopathies.
- Trial name
- NCT03166215
- Testing
- TAK-935
- Where
- 11 sites in United States
- Volunteers
- 18 people
- Sponsor
- Takeda
Celiac Disease
VTP-1000 in Adults With Celiac Disease
GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose…
- Trial name
- NCT06310291
- Testing
- VTP-1000
- Where
- 16 sites in United States
- Volunteers
- 42 people
- Sponsor
- Barinthus Biotherapeutics
Pharmacokinetics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets After Dose Escalation in Healthy Subjects
The safety and tolerability of multiple oral administrations of GRT9906 at different doses was investigated in this clinical study. The prolonged-release tablets slowly release the active compound in the intestine.
- Trial name
- NCT03776110
- Testing
- GRT9906 PR tablet
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
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.
SARS-CoV-2 Infection
A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19
This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed…
- Trial name
- NCT04582318
- Testing
- NGM621
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
Atopic Dermatitis
A Phase Ib/IIa, Double-Blind, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of S-777469 in Subjects With Atopic Dermatitis
The purpose of this randomized, double-blind, placebo-controlled, sequential-cohort, dose-escalation study was to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-777469, a CB2 cannabinoid receptor…
- Trial name
- NCT00697710
- Testing
- 50 mg S-777469, 200 mg S-777469, 800 mg S-777469
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Shionogi
Obese, Overweight
A Study of SA030 Injection in Overweight or Obese Participants
This study is the first time SA030 is being given to people. The goal is to understand how safe it is, how well it is tolerated, and how the body processes and responds to a single dose of SA030 in individuals who are overweight…
- Trial name
- NCT07479862
- Testing
- SA030 Injection
- Where
- 2 sites in Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Suzhou Siran Biotechnology Co.,Ltd.
Systemic Sclerosis
Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis
Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis.
- Trial name
- NCT06414135
- Testing
- Relma-cel
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Liangjing Lu
Generalized Myasthenia Gravis
Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)
The purpose of this study is to assess the safety, tolerability, PK, PD, immunogenicity, and preliminary clinical activity of Cizutamig in patients with Generalized Myasthenia Gravis.
- Trial name
- NCT07215650
- Testing
- Cizutamig
- Where
- 10 sites in China
- Volunteers
- 44 people
- Sponsor
- Candid Therapeutics
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to…
- Conditions
- Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Myelofibrosis Transformation in Essential Thrombocythemia, Myelofibrosis With High Molecular Risk Mutations
- Trial name
- FM-MF-02 (NCT07750574)
- Testing
- Flonoltinib Maleate orally
- Volunteers
- 105 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Type 2 Diabetes
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)
This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.
- Trial name
- NCT00758680
- Testing
- MK-1006
- Volunteers
- 112 people
- Sponsor
- Merck Sharp & Dohme LLC
Obesity
A Study to Evaluate ALN-6222 in Participants With Obesity
This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222…
- Trial name
- NCT07624071
- Testing
- ALN-6222
- Where
- Canada
- Volunteers
- 88 people
- Sponsor
- Alnylam Pharmaceuticals
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.
Guillain-Barre Syndrome
Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS).
- Trial name
- NCT04701164
- Testing
- ANX005
- Where
- 11 sites in Bangladesh, Philippines
- Volunteers
- 242 people
- Sponsor
- Annexon, Inc.
Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
This study is a randomised, double-blind, placebo controlled, phase Ib trial in subjects with suspected or confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis
- Trial name
- NCT04607655
- Testing
- GB1211
- Sponsor
- Galecto Biotech AB
Solid Tumors
Safety, Pharmacokinetics and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab in Participants With Solid Tumors in Chinese Participants
This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid…
- Trial name
- NCT05644626
- Testing
- BGB-B167, Tislelizumab
- Sponsor
- BeiGene
Systemic Lupus Erythematosus
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Trial name
- NCT07011043
- Testing
- Budoprutug
- Where
- 18 sites in United States, Bulgaria and 6 more
- Volunteers
- 30 people
- Sponsor
- Climb Bio, Inc.
Phase 1, Multiple Dose
A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects.
The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given…
- Conditions
- Phase 1, Multiple Dose, Safety, Toleration
- Trial name
- NCT01091532
- Testing
- UK-396,082
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer
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