Clinical trials: Pharmacodynamics
Rheumatoid Arthritis
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period.
- Trial name
- NCT01253226
- Testing
- LY2127399 (Tabalumab)
- Where
- 10 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)
The primary purpose of this study is to evaluate the safety and tolerability of ION440.
- Trial name
- NCT06430385
- Testing
- ION440
- Where
- 12 sites in United States, Austria and 3 more
- Volunteers
- 48 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Preeclampsia
Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant…
- Trial name
- NCT06924385
- Testing
- Telpegfilgrastim Injection
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Healthy Volunteers, Hypercholesterolemia
A Study of LY3015014 in Healthy Participants With High Cholesterol
This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins.
- Trial name
- NCT01671085
- Testing
- LY3015014
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Paroxysmal Nocturnal Hemoglobinuria
Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
- Trial name
- NCT05889299
- Testing
- OMS906
- Where
- Ukraine
- Volunteers
- 15 people
- Sponsor
- Omeros Corporation
Atopic Healthy Subjects, Adult Subjects With Allergic Diseases
A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases
This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have…
- Trial name
- NCT05564221
- Testing
- YH35324, Omalizumab
- Where
- 9 sites in South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy Volunteers, Multiple Sclerosis
Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients
In this first in human study the aim is to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in 18…
- Trial name
- NCT02048358
- Testing
- 2B3-201, Methylprednisolone hemisuccinate
- Where
- 2 sites in Netherlands
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- BBB-Therapeutics B.V.
Cachexia, Non-Small-Cell Lung Cancer
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
- Conditions
- Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT04299048
- Testing
- PF-06946860
- Where
- 10 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pfizer
Type 1 Diabetes Mellitus
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia
Primary Objective: To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia.
- Trial name
- NCT02635243
- Testing
- SAR438544, r-glucagon, insulin
- Sponsor
- Sanofi
Gastroesophageal Reflux Disease
A Study to Compare PK, PD and Safety of the AD-214 10/600mg and Rabeprazole
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 10/600mg to Rabeprazole 10mg in healthy volunteers.
- Trial name
- NCT04494243
- Testing
- AD-214 10/600mg, Rabeprazole 10mg
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Overweight, Healthy Volunteers
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
- Trial name
- NCT05096598
- Testing
- ZP8396
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Healthy
Safety, Tolerability, Effect of Vildagliptin and How the Body Changes the Blood Level of Vildagliptin in Healthy Chinese Volunteers
The purpose of this study is to assess the safety, tolerability, effect of vildagliptin and how the body changes the blood level of vildagliptin of single and multiple oral doses of vildagliptin in healthy Chinese volunteers.
- Trial name
- NCT00419887
- Testing
- Vildagliptin (LAF237)
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novartis
Essential Hypertension
Study of the Product QGC001 as a Single Dose and Multiple Doses Administered Orally to Healthy Adult Subjects
1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (SAD \& MAD) in healthy young subjects, the preliminary food interaction and the effect of QGC001 on blood pressure and…
- Trial name
- NCT01900184
- Testing
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Quantum Genomics SA
TTR-mediated Amyloidosis
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01617967
- Testing
- Patisiran
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 29 people
- Sponsor
- Alnylam Pharmaceuticals
End-Stage Kidney Disease (ESKD)
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533. The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard…
- Trial name
- NCT07759167
- Testing
- REGN9933, REGN7508, REGN9533
- Where
- Belgium
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Healthy Volunteer
A Study of RO5285119 in Healthy Volunteers
This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers.
- Trial name
- NCT01418963
- Testing
- RO5285119
- Where
- 2 sites in France
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH
- Trial name
- NCT02352493
- Testing
- ALN-CC5, Sterile Normal Saline (0.9% NaCl)
- Where
- 4 sites in Spain, United Kingdom
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Erythematotelangiectatic Rosacea
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single…
- Trial name
- NCT00989014
- Testing
- CD07805/47
- Where
- 5 sites in United States
- Volunteers
- 122 people
- Sponsor
- Galderma R&D
Procedural Sedation
A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability
A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in…
- Trial name
- NCT03329014
- Testing
- Remimazolam
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Major Depressive Disorder
Safety and Pharmacodynamic Study of ABT-436 in Major Depressive Disorder
This is a multiple-dose study to assess the safety and pharmacology of ABT-436 in physically healthy subjects with mild to moderate depressive symptoms who are not taking any antidepressant medication.
- Trial name
- NCT01380704
- Testing
- ABT-436
- Volunteers
- 51 people
- Sponsor
- AbbVie
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