Clinical trials: Pharmacokinetics and Pharmacodynamics
Healthy Volunteers
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884
A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers
- Trial name
- NCT03001297
- Testing
- MEDI5884 Dose 1, MEDI5884 Dose 2, MEDI5884 Dose 3
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Overweight and Obesity
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
- Trial name
- DA168 (NCT06534320)
- Testing
- DA-302168S
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Healthy
First-in-Human Single and Multiple Dose of GLPG1972
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo.
- Trial name
- NCT02612246
- Testing
- GLPG1972 single ascending doses, GLPG1972 multiple ascending doses
- Where
- Belgium
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Diabetes Mellitus, Type 1
AT278 and NovoRapid® in Glucose Clamp Study
A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting.
- Trial name
- NCT04660305
- Testing
- AT278, NovoRapid
- Where
- Austria
- Volunteers
- 38 people
- Sponsor
- Arecor Limited
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
- Trial name
- NCT07782450
- Testing
- PF-08154225
- Volunteers
- 54 people
- Sponsor
- Pfizer
Advanced Solid Tumor
A First-in-Human Study of BG-92505 Alone or in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
The purpose of this study is to test if the BG-92505 is safe and if it works in patients with advanced solid tumors when it is given on its own or in combination with anti-cancer agents.
- Trial name
- NCT07896460
- Testing
- BG-92505, Anti-Cancer Agent
- Volunteers
- 137 people
- Sponsor
- BeOne Medicines
Solid Tumors
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.
- Trial name
- NCT00882180
- Testing
- ALN-VSP02
- Where
- 10 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy
A First in Human Trial Evaluating THB335 in Healthy Participants
This study is a double blind, randomized, placebo-controlled, Phase 1 study in three parts: single ascending doses and food effect (Part 1), multiple ascending doses (Part 2) and Relative Bioavailability of Two Formulations (Part…
- Trial name
- NCT06425861
- Testing
- THB335 single dose, THB335 fasted/fed, THB335 multiple dose
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Third Harmonic Bio, Inc.
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Healthy
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects
Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.
- Trial name
- NCT02777008
- Testing
- CTP-543
- Where
- Australia
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Healthy
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses…
- Trial name
- NCT06715540
- Testing
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
- Trial name
- NCT06716190
- Testing
- Mid-dose bid BI 3731579, Midazolam, Low-dose bid BI 3731579
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Atopic Dermatitis
Evaluation of NM26-2198 in Healthy Subjects and in Patients With Moderate-to-severe Atopic Dermatitis (AD)
This is a randomized, double-blind, placebo-controlled, single- and multiple ascending dose study of subcutaneous (SC) administration of NM26-2198 in healthy volunteers and adult patients with moderate to-severe AD to evaluate…
- Trial name
- NCT05859724
- Testing
- NM26-2198
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Yellow Jersey Therapeutics AG
Dyslipidemias, Familial Hypercholesterolemia
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial…
- Conditions
- Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
- Trial name
- NCT03747224
- Testing
- ARO-ANG3, sterile normal saline (0.9% NaCl)
- Where
- 6 sites in Australia, New Zealand
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Pharmacokinetics, Pharmacodynamics
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamic (PD) biosimilarity of…
- Conditions
- Pharmacokinetics, Pharmacodynamics, Insulin Aspart
- Trial name
- NCT07560150
- Testing
- I004, NovoLog
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Healthy Volunteers
A Study of LY4178256 in Healthy Participants
The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants.
- Trial name
- NCT07698210
- Testing
- LY4178256
- Where
- 2 sites in United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
PK in Healthy Volunteers
A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
The goal of this study type: PK clinical trial is to evaluate the safety, tolerability, and pharmacokinetics/ pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers.
- Trial name
- P2203 phase I (NCT06698861)
- Testing
- PEG-MetHuG-CSF, Neulasta (Amgen)
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- PharmaEssentia
Healthy Volunteers
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of KL0011034 Injection Administered by Continuous Infusion in Healthy Adult Subjects
This study is a randomized, double-blind, propofol position-controlled trial, evaluating the safety, tolerability, and pharmacodynamic of continuous infusion of KL0011034 injection compared with propofol injectable emulsion for…
- Trial name
- NCT07828470
- Testing
- KL0011034 injection, propofol injectable emulsion
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Renal Insufficiency, Chronic, Kidney Disease, Chronic
A Study of LY2928057 in Hemodialysis Participants
This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant…
- Trial name
- NCT01991483
- Testing
- LY2928057
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
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