Clinical trials: Safety and Tolerability in Healthy Volunteers
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
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
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.
- Trial name
- NCT01343719
- Testing
- BI 661051
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects, Pneumococcal Infections
Study Evaluating Pneumococcal Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
- Trial name
- NCT00205803
- Testing
- 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
- Where
- United States
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Diarrhea
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes…
- Trial name
- NCT01739231
- Testing
- ACE527, dmLT, H10407 challenge strain
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- PATH
Healthy Volunteers
First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects
This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.
- Trial name
- NCT03055403
- Testing
- M201-A Injection
- Where
- Japan
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Yuji KUMAGAI
Healthy Volunteers
Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.
- Trial name
- NCT01262794
- Testing
- CDP6038
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy Subjects
A Single Ascending Dose Study To Evaluate Safety And Pharmacokinetics Of Compound PF-06648671 In Healthy Subjects
This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.
- Trial name
- NCT02316756
- Testing
- PF-06648671
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in…
- Trial name
- NCT05285137
- Testing
- CD388 Injection
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.
- Trial name
- NCT07474545
- Testing
- KL0011034 injection, Etomidate Injectable Emulsion
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Healthy Adult Subjects
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects.
- Trial name
- NCT01537172
- Testing
- ONO-4053
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Skin Disease, Immune System Disease
A Study of HL40626S Tablets in Healthy Adults
This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and…
- Conditions
- Skin Disease, Immune System Disease, Skin Diseases, Papulosquamous, Psoriasis (PsO)
- Trial name
- NCT07736586
- Testing
- HL40626S tablets
- Where
- 2 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- HighsLab Therapeutics Inc.
Safety and Tolerability in Healthy Volunteers
Phase I Study of VLX-1005 in Healthy Subjects
The principal objective of this study is to describe the safety of and tolerability to single and multiple doses of VLX-1005 in healthy subjects following intravenous (IV) administration.
- Trial name
- NCT04783545
- Testing
- VLX-1005
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Veralox Therapeutics
Healthy Participants
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-06842874 in Healthy Participants
This study will be the first time PF-06842874 is administered to humans. The purpose of Part A of the study is to investigate the safety, tolerability, and pharmacokinetics of PF-06842874 following administration of single oral…
- Trial name
- NCT04124653
- Testing
- PF-06842874, Relative Bioavailability
- Where
- 2 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Pfizer
Type 2 Diabetes Mellitus
Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans.
- Trial name
- NCT01386541
- Testing
- BYK324677
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- Nycomed
Healthy
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers
The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.
- Trial name
- NCT00619931
- Testing
- APD791
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Arena Pharmaceuticals
Comparison of Octaplas LG and Octaplas SD
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters.
- Trial name
- NCT01063595
- Testing
- Octaplas LG, Octaplas SD
- Where
- Austria
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Octapharma