Clinical trials: Safety and Pharmacokinetics in Healthy Volunteer Subjects
Healthy
A Study of LY3463251 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
- Trial name
- NCT03764774
- Testing
- LY3463251
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
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
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
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.
Healthy Volunteers
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States
- Trial name
- NCT02858973
- Testing
- Q203
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Qurient Co., Ltd.
Ataxia Telangiectasia
Comparative Bioavailability of Betamethasone Oral Solution Metered Spray (GTX-102) in Healthy Subjects
A Randomized, Open-label, Crossover Study to Evaluate the Comparative Bioavailability, Pharmacokinetics, and Safety of GTX-102 Administered as an Oral Spray Compared to Intramuscular Injection - betamethasone and an Oral Solution…
- Trial name
- NCT05531890
- Testing
- GTX-102 medium dose fast Period 1 and Period 2, GTX-102 medium dose slow Period 1 and Period 2, GTX-102 high dose fast Period 1 and Period 2
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Grace Therapeutics Inc.
Healthy Volunteer
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or…
- Trial name
- NCT02711423
- Testing
- Gantenerumab
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Healthy Subjects
A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229
This is a Phase I, single-center, randomized, single-blind, placebo-controlled study in healthy subjects assessing the safety, tolerability and pharmacokinetic profile of three different dose levels of M6229 when administered…
- Trial name
- NCT07285603
- Testing
- M6229
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Matisse Pharmaceuticals
Pharmacokinetics, Cancer
Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five treatment periods.
- Trial name
- NCT03326986
- Testing
- MK-7252
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Depressive Disorder, Major
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.
- Trial name
- NCT00440427
- Testing
- Desvenlafaxine Sustained Release (DVS SR)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Volunteer
Safety, Tolerability, and Dose Response of VNA-318 in Healthy Males
This is a phase 1, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) and multiple ascending doses (MAD) of VNA-318 in…
- Trial name
- NCT06721091
- Testing
- VNA-318
- Where
- France
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- VANDRIA
Healthy
Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.
- Trial name
- NCT00627120
- Testing
- VGX-1027
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- VGX Pharmaceuticals, LLC
Anemia
A Safety and Tolerability Study of AG-519 in Healthy Subjects
The purpose of the study is to investigate a drug called AG-519, which is being developed for the treatment of a disease called pyruvate kinase deficiency (also known as PK deficiency) and other forms of anemia.
- Trial name
- NCT02630927
- Testing
- AG-519
- Where
- United Kingdom
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy Volunteers
Phase 1 Study of NPT200-11 in Healthy Subjects
The purpose of this study is to determine the safety, tolerability and blood levels of orally administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be determined.
- Trial name
- NCT02606682
- Testing
- NPT200-11
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Neuropore Therapies Inc.
Hepatic Insufficiency
Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers
To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic impairment in comparison to healthy subjects
- Trial name
- NCT02265627
- Testing
- BIIL 284 BS
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
- Trial name
- NCT00788294
- Testing
- tanezumab
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer
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