Clinical trials: Pharmacodynamics
Cutaneous T-cell Lymphoma (CTCL)
A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL).
This is a Phase 1, dose escalation study to assess the safety, tolerability, pharmacokinetic and pharmacodynamic effects of CDK-003.
- Trial name
- Part B (NCT05156229)
- Testing
- CDK-003
- Where
- 4 sites in United Kingdom
- Volunteers
- 2 people
- Sponsor
- Codiak BioSciences
OTC Deficiency, Ornithine Transcarbamylase Deficiency
A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD
Evaluate the safety and pharmacodynamics of multiple doses of ARCT-810 in adolescent and adult participants with OTC deficiency.
- Conditions
- OTC Deficiency, Ornithine Transcarbamylase Deficiency, OTCD
- Trial name
- NCT06488313
- Testing
- ARCT-810
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Arcturus Therapeutics, Inc.
HIV-1 Infection
A Phase Ⅱa Clinical Study of CL-197 Capsules
This study will evaluate the antiretroviral activity, safety and pharmacokinetics of single dose of CL-197 capsule in three dose groups administered to antiretroviral treatment-naïve adult participants with human immunodeficiency…
- Trial name
- NCT07308782
- Testing
- CL-197 capsules
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Henan Genuine Biotech Co., Ltd.
Healthy
A Study in Healthy Participants to Evaluate the Effect of JNJ-54175446 on Amyloid Biomarkers and Cytokine Profiles in Cerebrospinal Fluid and Plasma
The primary purpose of this study is to investigate the effects of JNJ-54175446 (dose response) on levels of Aβ fragments (Aβ1-42, Aβ1-40, Aβ1-38, Aβ1-37) in plasma and cerebrospinal fluid (CSF), the effects of JNJ-54175446 on…
- Trial name
- NCT02933762
- Testing
- JNJ-54175446
- Where
- Belgium
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Diffuse Large B-Cell Lymphoma, B-cell Malignancies
A Study Investigating the Safety and How the Trispecific T-Cell Engaging Antibody BG-T0920 Works in Adults With Diffuse Large B-cell Lymphoma (DLBCL) and Other Aggressive B-Cell Malignancies
The purpose of this study is to test the safety and tolerability of BG-T0920 and to identify the recommended dose and dosing schedule (including dose levels and timing) that can be taken without having serious side effects in…
- Trial name
- NCT07887646
- Testing
- BG-T0920
- Volunteers
- 70 people
- Sponsor
- BeOne Medicines
Rheumatoid Arthritis
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
- Trial name
- NCT07171983
- Testing
- BMS-986454
- Where
- 9 sites in India
- Volunteers
- 46 people
- Sponsor
- Bristol-Myers Squibb
Primary Hyperoxaluria Type 1 (PH1)
Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
The goal of the redePHine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in participants with primary hyperoxaluria type 1 (PH1). The trial will consist of 2 Study Periods.
- Trial name
- NCT06839235
- Testing
- ABO-101
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 23 people
- Sponsor
- Arbor Biotechnologies
Healthy
A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255
1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects 2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects 3.
- Trial name
- NCT03174613
- Testing
- LC51-0255
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- LG Chem
Huntington's Disease
Study Exploring Safety, Pharmacokinetic and Pharmacodynamic of BN82451 in Male Huntington's Disease Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for 28 days in patients with Huntington's Disease…
- Trial name
- NCT02231580
- Testing
- BN82451B
- Where
- Germany
- Volunteers
- 17 people
- Sponsor
- Ipsen
Healthy
Safety and Tolerability of CDX-6114 in Healthy Volunteers
The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers.
- Trial name
- NCT03577886
- Testing
- CDX-6114
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Codexis Inc.
Healthy Subjects
Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects
The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy…
- Trial name
- NCT07364669
- Testing
- Insulex® R (soluble human insulin, biosimilar), Humulin® R (soluble human insulin, biosimilar)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Laboratorios Pisa S.A. de C.V.
Healthy
A PHASE I, RANDOMIZED, PLACEBO-CONTROLLED, SINGLE DOSE ESCALATION STUDY TO INVESTIGATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SHR0534 IN HEALTHY VOLUNTEERS
This is a randomized, placebo-controlled, single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534.
- Trial name
- NCT02749097
- Testing
- SHR0534
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Postmenopausal Osteoporosis
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women
This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.
- Trial name
- NCT01321723
- Testing
- PTH analog, Forsteo (Teriparatide)
- Where
- 4 sites in Denmark, Estonia
- Volunteers
- 97 people
- Sponsor
- Unigene Laboratories Inc.
Fecal Incontinence
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of a Single Rectal Application of 10 mg NRL001 in Elderly Subjects
A total of 26 healthy elderly male and female subjects will receive both 10 mg NRL001 in a 2 g rectal suppository and placebo in this double-blind, cross-over study.
- Trial name
- NCT01099683
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Norgine
Elevated LDL Cholesterol
Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of…
- Trial name
- NCT01362218
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), Simvastatin, ramipril, acetylsalicylic acid
- Where
- Spain
- Volunteers
- 107 people
- Sponsor
- Ferrer Internacional S.A.
Hepatitis C
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)
The objective of this study is to identify a safe dose of MK-2248 in participants with Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from baseline.
- Trial name
- NCT02161510
- Testing
- MK-2248
- Volunteers
- 13 people
- Sponsor
- Merck Sharp & Dohme LLC
Atopic Dermatitis
A Dose-ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Galvokimig in Adult Study Participants With Atopic Dermatitis
The purpose of the study is to evaluate the dose-response relationship of galvokimig compared with placebo in study participants with moderate-to-severe atopic dermatitis (AtD).
- Trial name
- PossibILity (NCT07277660)
- Testing
- Galvokimig
- Where
- 59 sites in United States, Bulgaria and 7 more
- Volunteers
- 165 people
- Sponsor
- UCB Biopharma SRL
Advanced Solid Tumors (Including GCTTS)
An Exploratory Clinical Study of BC006 in Patients With Advanced Solid Tumors
This is a first in human, open-label, exploratory phase I clinical study including dose escalation (Ia) and dose expansion (Ib) stage.
- Trial name
- NCT05212896
- Testing
- BC006
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Dragonboat Biopharmaceutical Company Limited
Sedation, Pain
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous…
- Trial name
- NCT01378988
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Healthy
A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321
This is a single centre, three single administrations (Days 1, 29 and 57) at increasing doses of IMP321 (3, 10, 30 and 100 µg) in four cohorts of 12 subjects, single blind, randomized study.
- Trial name
- NCT00354861
- Testing
- hepatitis B antigen (without alum) plus IMP321, hepatitis B antigen alone (without alum), Engerix B
- Where
- France
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Immutep S.A.S.
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