Clinical trials: Pharmacokinetics
Melanoma, Non Small Cell Lung Cancer
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary
- Trial name
- PRESERVE-009 (NCT05858736)
- Testing
- AI-061
- Where
- 5 sites in Australia
- Volunteers
- 18 people
- Sponsor
- OncoC4, Inc.
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)
This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL.
- Conditions
- Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle-cell Lymphoma
- Trial name
- NCT02631044
- Testing
- JCAR017 (lisocabtagene maraleucel) single-dose schedule, JCAR017 (lisocabtagene maraleucel) 2-dose schedule
- Where
- 14 sites in United States
- Volunteers
- 387 people
- Sponsor
- Juno Therapeutics, a Subsidiary of Celgene
Atopic Dermatitis
A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants…
- Trial name
- NCT05277571
- Testing
- UCB1381
- Where
- 16 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy Volunteers
A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016
This is a single dose-escalation phase Ⅰa clinical study to observe the safety and pharmacokinetic profiles of RBD1016 in healthy subjects.
- Trial name
- NCT04685564
- Testing
- RBD1016
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Suzhou Ribo Life Science Co. Ltd.
Osteoarthritis
A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee
This is a randomized, placebo-controlled, participant- and Investigator-blinded Phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending single intra-articular doses of SAR446959 in…
- Trial name
- NCT06704932
- Testing
- SAR446959
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- Sanofi
Obesity
Pharmacokinetics of Dexmedetomidine in Morbid Obesity
Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects.
- Trial name
- NCT01864187
- Testing
- Dexmedetomidine
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Guangzhou General Hospital of Guangzhou Military Command
Friedreich Ataxia
A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia
The primary objective of the study is to assess the pharmacokinetics (PK) and safety of vatiquinone administered in participants with Friedreich ataxia (FA) younger than 7 years.
- Trial name
- NCT05485987
- Testing
- Vatiquinone
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- PTC Therapeutics
HIV Infections
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with…
- Trial name
- NCT00000893
- Testing
- Nelfinavir mesylate, Efavirenz
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 103 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.
- Trial name
- NCT05249621
- Testing
- MZE001
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Maze Therapeutics
Chronic Obstructive Pulmonary Disease
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the…
- Trial name
- NCT01068184
- Testing
- AZD6553
- Where
- United Kingdom
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hemophilia A
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital…
- Trial name
- ZEBRHA 2 (NCT07416604)
- Testing
- NXT007, Emicizumab
- Where
- 59 sites in United States, Argentina and 20 more
- Volunteers
- 360 people
- Sponsor
- Hoffmann-La Roche
Obesity
Pharmacokinetics of Dexamethasone in COVID-19 Obese Patients
In this regard, the present research project aims to compare dexamethasone PK in normal-weight versus obese patients treated for COVID-19.
- Trial name
- CoDEX (NCT04996784)
- Testing
- Capillary blood sampling
- Where
- Switzerland
- Volunteers
- 30 people
- Sponsor
- Jules Desmeules
Anesthesia
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
The purpose of this study is: to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants…
- Trial name
- NCT00421148
- Testing
- Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Safety Issues, Tolerance
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Trial name
- NCT05217732
- Testing
- ZX-7101A
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Zenshine Pharmaceuticals
Papulopustular Rosacea
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
Rosacea is a common chronic inflammatory relapsing-remitting skin condition almost exclusively affecting the central area of the face and the eyes.
- Trial name
- NCT05150587
- Testing
- Rifaximin
- Where
- 38 sites in United States
- Volunteers
- 216 people
- Sponsor
- Alfasigma S.p.A.
Healthy Volunteers
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability…
- Trial name
- NCT04746287
- Testing
- CKD-510 single dose, CKD-510 food effect, CKD-510 multiple dose
- Where
- France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Psoriasis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).
- Trial name
- NCT01094093
- Testing
- AMG 139
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Multiple Myeloma
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed…
- Trial name
- NCT04075721
- Testing
- M3258, M3258 20 mg
- Where
- 7 sites in United States, France
- Volunteers
- 10 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
- Trial name
- P2_ABSSSI (NCT03964493)
- Testing
- TNP-2092, Vancomycin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- TenNor Therapeutics Limited