Clinical trials: Pharmacodynamics
Chronic Spontaneous Urticaria
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects.
- Trial name
- NCT07230418
- Testing
- HRS-3095 Tablet
- Where
- China
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
X-Linked Hypophosphatemia
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
The primary objectives of the study are to: Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers…
- Trial name
- NCT02750618
- Testing
- Burosumab
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin, Inc.
Hypercholesterolemia
Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)
Primary Objective: Injection Site Tolerability Secondary Objectives: To assess the safety profile of alirocumab SAR236553 (REGN727) To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)
- Trial name
- NCT01448239
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolemia
Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
This is a single center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3- LRX for reduction of low density lipoprotein cholesterol (LDL-C) levels in patients with Homozygous Familial Hypercholesterolemia (HoFH).
- Trial name
- NCT03455777
- Testing
- AKCEA-ANGPTL3-LRX
- Where
- Canada
- Sponsor
- Akcea Therapeutics
Still's Disease, Adult-Onset
Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APB-R3
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy…
- Trial name
- NCT05715736
- Testing
- APB-R3
- Where
- Australia
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Intradermal Injections
A Pilot Study to Assess the Safety, PK and PD of Insulin Injected Via MicronJet or Conventional Needle
The purpose of this study is to compare glucose pharmacokinetics and insulin pharmacodynamics injected via the MicronJet in comparison with a conventional needle.
- Trial name
- MicronJet (NCT00602914)
- Testing
- MicronJet
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- NanoPass Technologies Ltd
Pharmacodynamics, Pharmacokinetics
Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141
Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.
- Conditions
- Pharmacodynamics, Pharmacokinetics, Bioequivalence
- Trial name
- NCT05652595
- Testing
- GP40141, Nplate
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Geropharm
DM1, Muscular Dystrophies
Extension of AOC 1001-CS1 (MARINA) Study in Adult Myotonic Dystrophy Type 1 (DM1) Patients
AOC 1001-CS2 (MARINA-OLE) (NCT05479981) is a Phase 2 extension of the AOC 1001-CS1 (MARINA) (NCT05027269) study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple-doses of AOC 1001…
- Conditions
- DM1, Muscular Dystrophies, Myotonic Dystrophy, Myotonic Dystrophy 1
- Trial name
- MARINA-OLE (NCT05479981)
- Testing
- AOC 1001
- Where
- 8 sites in United States
- Volunteers
- 37 people
- Sponsor
- Avidity Biosciences, Inc.
Autoimmune Thrombocytopenia, Warm Autoimmune Haemolytic Anaemia
IASO-782 in Autoimmune Hematological Diseases
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases.
- Trial name
- NCT06534021
- Testing
- IASO-782 injection
- Where
- 2 sites in China
- Volunteers
- 16 people
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
Diabetes Mellitus, Type 1
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.
- Trial name
- NCT02038764
- Testing
- PF-06342674 Dose A, PF-06342674 Dose B, PF-06342674 Dose C
- Where
- 21 sites in United States
- Volunteers
- 37 people
- Sponsor
- Pfizer
Pain, Acute
Epidural Methadone in Healthy Volunteers
Epidurally administered opioid pain medications are important tools for postoperative pain control, but each agent has its own limitations.
- Trial name
- NCT03525509
- Testing
- Methadone hydrochloride, Morphine Sulfate
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- simon.haroutounian
Acoustic Schwannoma, Adult Anaplastic (Malignant) Meningioma
RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 (RO4929097) when given together with temozolomide and radiation therapy in treating patients with newly…
- Conditions
- Acoustic Schwannoma, Adult Anaplastic (Malignant) Meningioma, Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma
- Trial name
- NCT01119599
- Testing
- 3-Dimensional Conformal Radiation Therapy, Gamma-Secretase Inhibitor RO4929097, Intensity-Modulated Radiation Therapy
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Cancer Institute (NCI)
Healthy
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.
- Trial name
- NCT02232087
- Testing
- Salmeterol, fluticasone propionate
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Kindeva Drug Delivery
FXI
Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects
The purpose of this study is to evaluate safety, tolerability, PK, and PD of SAD of FXI-GalNAc-siRNA administered SC to healthy subjects.
- Trial name
- NCT05844293
- Testing
- FXI-GalNAc-siRNA
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sirnaomics
Rare Diseases
A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.
- Trial name
- NCT04765553
- Testing
- NI-0501, Saline
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Non Small Cell Lung Cancer
A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer
Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and…
- Trial name
- NCT01121575
- Testing
- PF-02341066, PF-00299804
- Where
- 10 sites in United States, Australia
- Volunteers
- 70 people
- Sponsor
- Pfizer
Pulmonary Arterial Hypertension
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial…
- Trial name
- AIR001-CS02 (NCT00814645)
- Testing
- Sodium Nitrite Inhalation Solution
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aires Pharmaceuticals, Inc.
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.
- Trial name
- NCT02033239
- Testing
- Faster-acting insulin aspart, insulin aspart
- Where
- Germany
- Volunteers
- 46 people
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
Single Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117
The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating single oral doses of AEF0117 in healthy adult male and female subjects.
- Trial name
- NCT03325595
- Testing
- AEF0117
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Aelis Farma
Rheumatoid Arthritis
A Phase Ⅰ Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SHR-3045 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
- Trial name
- NCT06883695
- Testing
- SHR-3045 Injection
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd