Clinical trials: Drug Kinetics
Healthy
A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.
The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after dosing a combination of the study medications.
- Trial name
- NCT00280358
- Testing
- Fluticasone Propionate, Formoterol Fumarate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dey
SARS CoV 2 Infection
A Study of EDP-235 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.
- Trial name
- NCT05246878
- Testing
- EDP-235
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
HCV Infection
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection.
- Trial name
- NCT01193478
- Testing
- GS-5885
- Where
- 13 sites in United States
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
Advanced Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND5071 as a Single Agent in Adult Patients With Advanced Solid Tumors
This is a Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and/or recommended Phase 2 dose (RP2D) and assess the DLT of FHND5071.
- Trial name
- NCT05818917
- Testing
- FHND5071
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Hypotension
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children.
- Trial name
- NCT00135668
- Testing
- Nitroprusside
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- The Emmes Company, LLC
Advanced Solid Tumors, Metastatic Solid Tumors
First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors
This study is an open-label, multicenter, first-in-human, Phase I, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic…
- Trial name
- NCT05494918
- Testing
- JSKN003
- Where
- Australia
- Volunteers
- 62 people
- Sponsor
- Alphamab (Australia) Co Pty Ltd.
Sporadic Inclusion Body Myositis
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis
- Trial name
- NCT01423110
- Testing
- BYM338
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male…
- Trial name
- NCT05738993
- Testing
- BCD-178, Perjeta
- Where
- 2 sites in Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biocad
Relapsed/Refractory Hematological Malignancies, Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
A Study of APG-3288 in Relapsed/Refractory Blood Cancers
This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients…
- Conditions
- Relapsed/Refractory Hematological Malignancies, Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL, Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation), Relapsed/Refractory Mantle Cell Lymphoma (MCL)
- Trial name
- NCT07424833
- Testing
- APG-3288
- Where
- 6 sites in United States, China
- Volunteers
- 180 people
- Sponsor
- Ascentage Pharma Group Inc.
AD
A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT07693738
- Testing
- SSGJ-716
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Complicated Urinary Tract Infection, Acute Pyelonephritis
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary…
- Trial name
- NCT01096849
- Testing
- levofloxacin, plazomicin
- Volunteers
- 145 people
- Sponsor
- Achaogen, Inc.
Recurrent or Metastatic, Advanced Solid Tumors
Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors
A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors
- Trial name
- NCT06292858
- Testing
- IMB071703 injection
- Where
- China
- Volunteers
- 93 people
- Sponsor
- Beijng Immunoah Pharma Tech Co., Ltd.
Edematous Fibrosclerotic Panniculopathy
Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP
This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP).
- Trial name
- NCT03675685
- Testing
- CCH (collagenase clostridium histolyticum)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Advanced Solid Tumor
A Study of EOC237 in Patients With Advanced Solid Tumor
This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.
- Trial name
- NCT05895825
- Testing
- EOC237
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Hereditary Hemorrhagic Telangiectasia
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
The purpose of this study is to: evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers evaluate the efficacy, safety, tolerability and PD of…
- Trial name
- InsigHHT (NCT06659640)
- Testing
- ALN-6400
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Cancer, Advanced Solid Malignancies
Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects
The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.
- Trial name
- NCT01340040
- Testing
- MEDI-573
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
B-Cell Non-Hodgkin's Lymphoma
HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
A Multicenter, Open-label, Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of HMPL-760 in Patients with Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
- Trial name
- NCT05190068
- Testing
- HMPL-760
- Where
- 22 sites in China
- Volunteers
- 89 people
- Sponsor
- Hutchmed
Hemophilia A
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Primary objective To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives To characterize additional pharmacokinetic…
- Trial name
- NCT05042440
- Testing
- Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol
- Where
- Bulgaria
- Volunteers
- 13 people
- Sponsor
- Sanofi
Anti-Hepatitis A Antibody Levels in Heathy Subjects
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled.
- Trial name
- GamaSTAN (NCT03351933)
- Testing
- Immune Globulin (Human)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Grifols Therapeutics LLC