Clinical trials: Tolerability
Obesity, Healthy
Gastrointestinal Tolerability to Agavins and Impact on Host-gut Microbiota-metabolism Interactions Modulation
Agavins are branched neo-fructans and prebiotic fiber found in Agave plants. In preclinical studies, agavins have demonstrated an effect in reversing metabolic disorders associated to overweight and obesity through the modulation…
- Trial name
- NCT04555447
- Testing
- Agavins (prebiotic fiber)
- Where
- 2 sites in Mexico
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Centro De Investigación Y De Estudios Avanzados Del Instituto Politécnico Nacional-Unidad Irapuato
Atopic Dermatitis
A Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
This is a Phase 1, randomized, blinded, placebo controlled, single ascending dose (SAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).
- Trial name
- NCT07239947
- Testing
- BBT001
- Where
- 10 sites in China
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Bambusa Therapeutics
Healthy
A Study of a Baby Wash/Shampoo and Baby Lotion Versus Baby Wash/Shampoo Alone for Impact on Skin Barrier and Microbiome on Newborns
The purpose of this study is to demonstrate the tolerance of a baby wash/shampoo alone and the tolerance of a regimen of a baby wash/shampoo and baby lotion in a newborn population.
- Trial name
- NCT05589038
- Testing
- Baby Lotion
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
Gaucher Disease
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.
- Trial name
- NCT01881633
- Testing
- ISU302
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ISU Abxis Co., Ltd.
Healthy
PK and Safety Study of HCP1102, HGP0813 and HGP1408
This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male…
- Trial name
- NCT03371849
- Testing
- montelukast and levocetirizine FDC, Singulair + xyzal
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Nonalcoholic Steatohepatitis
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and…
- Trial name
- NCT04137055
- Testing
- ZSP0678-10mg, ZSP0678-30mg, ZSP0678-60mg
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Respiratory Tract Infections
Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability, and acceptability of the investigational RD19 device among 25 healthy volunteers between the age of 18 and 45.
- Trial name
- NCT04557826
- Testing
- RD19
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- EmitBio Inc.
Smallpox
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
- Trial name
- NCT00053508
- Testing
- ACAM1000, vaccinia virus (calf lymph) smallpox vaccine: Dryvax
- Where
- 3 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Healthy Adult Subjects
A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new…
- Trial name
- NCT03960489
- Testing
- Roxadustat
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteer, Becker Muscular Dystrophy
A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults
EDG-5506 is an investigational product intended to protect and improve function of dystrophic muscle fibers. This Phase 1 study of EDG-5506 will assess the safety, tolerability, and pharmacokinetics (PK) and of EDG-5506 in adult…
- Trial name
- NCT04585464
- Testing
- EDG-5506
- Where
- United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Chronic Obstructive Pulmonary Disease
Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118
The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD).
- Trial name
- NCT01333904
- Testing
- PUR118
- Where
- United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Pulmatrix Inc.
Healthy
Safety and Tolerability of BI 685509 in Healthy Subjects
The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.
- Trial name
- NCT03116906
- Testing
- BI 685509
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study of LY3451838 in Healthy Participants
The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin).
- Trial name
- NCT03692949
- Testing
- LY3451838
- Where
- Singapore
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Covid19
A Clinical Study to Evaluate MW33 Injection
This randomized, double-blind, placebo-controlled, single-dose escalation trial will be conducted to evaluate the safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic characteristics of a single dose of MW33…
- Trial name
- NCT04533048
- Testing
- MW33 injection
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Bacterial Infections
A Phase 1 TP-271 Oral PK Multiple Ascending Dose Study
This is a phase 1, single-center, randomized, placebo-controlled, double-blind, multiple ascending-dose study to assess the safety, tolerability, and PK of oral TP-271 in healthy adult subjects.
- Trial name
- NCT03450187
- Testing
- TP-271
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Malaria,Falciparum
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants
This four-cohort, first-in-human, healthy participant study aims to assess the test medicine's safety and tolerability, including injection site reactions and how it is taken up by the body when given as a single dose.
- Trial name
- NCT06558643
- Testing
- MMV371 LAI
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Atherosclerosis
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
- Trial name
- NCT00551317
- Testing
- Darapladib (SB480848)
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects
This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD.
- Trial name
- NCT01167868
- Testing
- FosD
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China
The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.
- Trial name
- NCT05268068
- Testing
- Risankizumab
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy
Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464
A two part, fixed-sequence, open-label crossover study to evaluate potential CYP1A2-mediated drug-drug interactions of ABX464 in healthy subjects using caffeine and fluvoxamine as probe drugs
- Trial name
- NCT05121714
- Testing
- Caffeine, ABX464, Fluvoxamine
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Abivax S.A.
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