Clinical trials: Evaluate PK Profile
Burns
Evaluation Of Linezolid Pk Profile In Burns Patients
Evaluation of linezolid pk profile in burns patients
- Trial name
- NCT00255996
- Testing
- linezolid
- Where
- 3 sites in France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hemophilia a and B
KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors
The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity <1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%).
- Trial name
- NCT06747416
- Testing
- KN057
- Volunteers
- 24 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Non-small Cell Lung Cancer, Melanoma
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs.
- Conditions
- Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma
- Trial name
- NCT07160335
- Testing
- HLX17, US-sourced Keytruda®
- Where
- 69 sites in United States, China and 2 more
- Volunteers
- 174 people
- Sponsor
- Shanghai Henlius Biotech
Impaired Liver Function
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.
- Trial name
- NCT00741273
- Testing
- Proellex
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Metabolic Dysfunction-associated Steatohepatitis
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)
This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD).
- Trial name
- NCT07462455
- Testing
- ACT500 tablets
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Bronchiolitis
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.
- Trial name
- NCT00394160
- Testing
- MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
- Volunteers
- 12 people
- Sponsor
- Organon and Co
Hereditary Angioedema
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
This is a 3 part, phase 1 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824…
- Trial name
- NCT05118958
- Testing
- KVD824 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet, KVD824 Immediate-Release Capsule
- Where
- United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- KalVista Pharmaceuticals, Ltd.
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
Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants
This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult…
- Trial name
- NCT05863442
- Testing
- Soliris 300 MG in 30 ML Injection, TUR03 300 MG in 30 ML Injection
- Where
- Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Turgut Ardika PTY LTD
Multiple Sclerosis
A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
The primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri) at steady state. The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin saturation) of Tysabri at steady…
- Trial name
- NCT00744679
- Testing
- Natalizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Biogen
Nonalcoholic Fatty Liver Disease
The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects
A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal…
- Trial name
- NCT06044467
- Testing
- Anti-human CCL24 monoclonal antibody (CM-101) - Part One, Anti-human CCL24 monoclonal antibody (CM-101) - Part Two
- Where
- Israel
- Volunteers
- 16 people
- Sponsor
- ChemomAb Ltd.
Overweight or Obesity
A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects
To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
- Trial name
- NCT06973681
- Testing
- BGM0504
- Where
- China
- Volunteers
- 120 people
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
Healthy
Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes.
- Trial name
- NTC00940472 (NCT01560481)
- Testing
- Step A: metformin glycinate 620 mg single dose, Step A: metformin glycinate 1240 mg single dose, Step A: metformin glycinate 2480 mg single dose
- Where
- Spain
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Renal Impairment
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
PK and safety profile of Proellex® in females with various stages of impaired renal function
- Trial name
- NCT00787618
- Testing
- 50 mg Proellex
- Where
- 4 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Gout, Hyperuricemia
SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
- Trial name
- NCT06678581
- Testing
- SAP-001
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Co., Ltd.
Healthy Volunteers
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects
- Trial name
- NCT03279146
- Testing
- Tenofovir exalidex (TXL)
- Where
- United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- ContraVir Pharmaceuticals, Inc.
Plaque Psoriasis
Treatment of Moderate to Severe Plaque Psoriasis
To assess the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis, as well as the PK and PD characteristics of multiple doses
- Trial name
- NCT06542614
- Testing
- TQH3906 capsules
- Where
- 35 sites in China
- Volunteers
- 209 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Safety, Antitumor Activity
FCN-338 in Combination With Azacitidine or Chemotherapy in Myeloid Neoplasms
This is a Phase 2, open-label, multicenter study to safety \& tolerability, antitumor activity, and pharmacokinetics of FCN-338 in Combination with szacitidine (AZA) or chemotherapy(erythromycin, cytarabine(Ara-C)) in Patients…
- Conditions
- Safety, Antitumor Activity, PK Profile
- Trial name
- NCT06858618
- Testing
- FCN-338 + Azacitidine, FCN-338 + erythromycin+ Ara-C
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Evaluate PK Profile
Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
The purpose of this study is to evaluate the Pharmacokinetics, Safety, Tolerability of Nirsevimab in Healthy Chinese Adults.
- Trial name
- PK/ADA (NCT04840849)
- Testing
- nirsevimab
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Idiopathic Pulmonary Fibrosis (IPF)
To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers
This is a Phase I stage to investigate the safety and tolerability of MG-S-2525 in healthy volunteers. The proposed trial consists of 3 study parts to be conducted at Tri-Service General Hospital and includes Single Ascending…
- Trial name
- NCT03650075
- Testing
- MG-S-2525
- Where
- Taiwan
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Metagone Biotech Inc.