Clinical trials: Safety and Tolerability in Healthy Subjects
- Condition Safety and Tolerability in Healthy Subjects
- Funder type Industry (pharma, biotech, devices)
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
Psoriasis Vulgaris
Multiple Dose Study With Incremental Dosing to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Doses of LEO 32731 in Healthy Male Japanese Subjects.
This trial will investigate the safety, tolerability and pharmacokinetic (PK) data of LEO 32731 (and major human metabolite LEO 40815) in healthy male Japanese subjects.
- Trial name
- NCT03231124
- Testing
- LEO 32731
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- LEO Pharma
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
Invasive Aspergillosis
Single Ascending Oral Dose Study of F901318
Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8 subjects.
- Trial name
- NCT02394483
- Testing
- F901318 safety, F901318 tolerability, F901318 pharmacokinetics
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- F2G Ltd
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
Healthy
Investigation of Single Rising Doses of BI 685509
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising oral doses of BI 685509
- Trial name
- NCT02694354
- Testing
- BI 685509
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
The purpose of this study is the following: To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
- Trial name
- NCT02537002
- Testing
- PF-05230907
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bronchial Asthma
Safety, Tolerability, and Pharmacokinetics of PA9159 Inhalation Aerosol in Healthy Adult Subjects
PA9159 is a highly potent novel corticosteroid. The purpose of this study is to exam the safety, tolerability, and pharmacokinetics of single and repeat dosing of Inhalation aerosol PA9159, to establish maximum tolerated dose in…
- Trial name
- NCT06916273
- Testing
- PA9159 Inhalation aerosol, 60 μg one day treatment, PA9159 Inhalation aerosol, 120 μg one day treatment, PA9159 Inhalation aerosol, 240 μg one day treatment
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Anhui Palo Alto Pharmaceuticals, Inc.
Generalized Pustular Psoriasis
A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP)
This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily…
- Trial name
- NCT06433531
- Testing
- TQH2929 Injection
- Where
- 7 sites in China
- Volunteers
- 9 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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.
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