Clinical trials: Pharmacodynamics
Non Hodgkin Lymphoma (NHL), Peripheral T-cell Lymphoma (PTCL)
Safety, PK, PD, Clinical Activity of KT-333 in Adult Patients With Refractory Lymphoma, Large Granular Lymphocytic Leukemia, Solid Tumors
This Phase 1a/1b study will evaluate the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of KT-333 in Adult patients with Relapsed or Refractory (R/R) Lymphomas, Large Granular Lymphocytic Leukemia (LGL-L)…
- Conditions
- Non Hodgkin Lymphoma (NHL), Peripheral T-cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Large Granular Lymphocytic Leukemia (LGL-L)
- Trial name
- NCT05225584
- Testing
- KT-333
- Where
- 13 sites in United States
- Volunteers
- 56 people
- Sponsor
- Kymera Therapeutics, Inc.
Advanced Malignant Solid Tumor, Malignant Pleural Effusion
A Study of MT027 in Patients with Pleural Malignant Tumors
This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK/PD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who…
- Conditions
- Advanced Malignant Solid Tumor, Malignant Pleural Effusion, Pleura Carcinoma, Pleural Mesothelioma
- Trial name
- NCT06726564
- Testing
- MT027 cells suspension
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Suzhou Maximum Bio-tech 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
Stargardt Disease 1, STGD1
A Phase 1, First-in-Human Study of CITY-RBP4 in Healthy Volunteers and STGD1 Participants
This is a first-in-human (FIH), multicenter, randomized, double-masked, placebo-controlled adaptive clinical study evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of CITY-RBP4, following…
- Conditions
- Stargardt Disease 1, STGD1, Healthy Volunteers
- Trial name
- NCT07836452
- Testing
- CITY-RBP4
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- City Therapeutics
Healthy
First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the…
- Trial name
- NCT03103438
- Testing
- BCD-089
- Where
- Russia
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Biocad
Dyslipidemia
A Study of AZD8233 in Participants With Dyslipidemia.
A Phase 1 and 2 Study of AZD8233 in Participants with Dyslipidemia and this study consists of Part A , Part B and Part C. Part A is designed as a randomized, single-blind (blinding of participants and sites), placebo-controlled…
- Trial name
- HAYATE (NCT04823611)
- Testing
- Part A:AZD8233, Part B:AZD8233
- Where
- 7 sites in Japan
- Volunteers
- 87 people
- Sponsor
- AstraZeneca
Dry Eye
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution…
- Trial name
- NCT03598699
- Testing
- AXR-159, Vehicle
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- AxeroVision, Inc.
Myelodysplastic Syndrome, Myelodysplastic Syndromes
Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)
This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts.
- Trial name
- NCT02929498
- Testing
- GSK2879552, Azacitidine
- Where
- 6 sites in United States, Spain
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Chemotherapy-induced Neutropenia
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer
The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients.
- Trial name
- NCT02725606
- Testing
- Pegylated Recombinant Human G-CSF, GW003
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
Inflammatory Bowel Diseases
A Safety and Tolerability Study of GSK2982772, in Single (in Both Fed and Fasted States) and Repeat Oral Doses in Healthy Male Subjects
This study is the first administration of GSK2982772 in humans. The study will evaluate the safety, tolerability, pharmacokinetics (PK), and exploratory pharmacodynamics (PD) of single and repeat oral doses of up to 14 days with…
- Trial name
- NCT02302404
- Testing
- GSK2982772 solution, GSK2982772 capsule
- Where
- United Kingdom
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-40411813 in Male and Female Elderly Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the study medication) and pharmacodynamics (the study of the action or effects the study medication has on the body) of…
- Trial name
- NCT01932333
- Testing
- JNJ-40411813 50 mg, JNJ-40411813 100 mg
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Rheumatoid Arthritis
Study, Evaluating Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety Profiles of Rituximab Compared to MabThera® in Patients With Rheumatoid Arthritis
A randomised, double blind, parallel group, multicentre study to compare the pharmacokinetics, pharmacodynamics, immunogenicity and safety of Rituximab (Mabscale LLC, Russia) versus MabThera® in patients with rheumatoid arthritis.
- Trial name
- NCT06175338
- Testing
- Rituximab, MabThera®
- Where
- 12 sites in Russia
- Volunteers
- 208 people
- Sponsor
- Mabscale, LLC
Healthy
Study Evaluating the Safety, Tolerability and Pharmacokinetics of Desvenlafaxine Succinate SR in Healthy Chinese Male and Females
The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects.
- Trial name
- NCT00818155
- Testing
- desvenlafaxine succinate SR
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Rheumatoid Arthritis
Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients
The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the receptor for interleukin 6 (IL6R), is safe and effective after single or multiple administrations to patients with rheumatoid arthritis…
- Trial name
- NCT01284569
- Testing
- ALX-0061
- Where
- 7 sites in Czechia, Hungary and 1 more
- Volunteers
- 65 people
- Sponsor
- Ablynx, a Sanofi company
Advanced Solid Tumors
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients.
- Trial name
- NCT00932126
- Testing
- PF-03758309
- Where
- 3 sites in United States, Australia
- Volunteers
- 35 people
- Sponsor
- Pfizer
Ischemic Stroke
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants
This study is a randomized, double-blind, placebo-controlled clinical trial featuring both single ascending dose (SAD), food effect and multiple ascending dose (MAD) phases intended to evaluate the safety, tolerability, PK, PD…
- Trial name
- NCT07371455
- Testing
- LWP779
- Where
- Australia
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Longwood Pharmaceuticals (Hangzhou) Co., Ltd.
Retinopathy of Prematurity (ROP)
Safety, PK and PD of FLQ-101 in Premature Neonates
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
- Trial name
- tROPhy-1 (NCT07093255)
- Testing
- FLQ-101
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- FELIQS INC.
Healthy Subjects
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects
The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses…
- Trial name
- NCT02571855
- Testing
- ACT-541468 (hydrochloride salt), ACT-541468 (free base)
- Where
- Netherlands
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Moderate to Severe Osteoarthritis
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
- Trial name
- NCT02095548
- Testing
- SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL, SM04690, 0.23mg/2mL
- Where
- 7 sites in United States
- Volunteers
- 61 people
- Sponsor
- Biosplice Therapeutics, Inc.
Parkinson Disease
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with…
- Trial name
- NCT05924243
- Testing
- RO7486967
- Where
- 17 sites in United States, Netherlands and 1 more
- Volunteers
- 60 people
- Sponsor
- Hoffmann-La Roche
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