Clinical trials: Tolerability
Staphylococcal Infections
Evaluation of a Single Vaccination With One of Three Ascending Dose Levels of a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years
This is a first-in-human (Phase 1) and Phase 2 study of a single vaccination with one of three dose levels of an investigational vaccine against Staphylococcus aureus (SA4Ag).
- Trial name
- NCT01364571
- Testing
- SA4Ag vaccine low dose, Blood draw, Colonization swab sample
- Where
- 16 sites in United States
- Volunteers
- 456 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and multiple ascending oral doses of JNJ-64991524…
- Trial name
- NCT03346122
- Testing
- JNJ-64991524 Dose Level 1, JNJ-64991524 Dose Level 2, JNJ-64991524 Dose Level 3
- Where
- Belgium
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy
Oral Bioavailability of Two Solid Formulations of GLPG0259.
The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.
- Trial name
- NCT01322451
- Testing
- GLPG0259 fumarate, GLPG0259 free base
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Healthy Subjects
Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
- Trial name
- NCT01199965
- Testing
- MAP0004, IV DHE
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Allergan
Healthy Volunteers
Clinical Trial of Naoqingzhiming Tablets in Healthy Chinese Subjects
A single-center, randomized, double-blind, placebo-controlled, dose escalation safety, tolerability, and pharmacokinetic phase I clinical study of Naoqingzhiming Tablets in Chinese healthy subjects.
- Trial name
- NCT04902534
- Testing
- Naoqingzhiming Tablets (contains echinacoside 180mg)
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- The Affiliated Hospital of Qingdao University
Healthy
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.
- Trial name
- NCT02431364
- Testing
- Verdinexor
- Where
- Australia
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Karyopharm Therapeutics Inc
COVID-19 Disease
ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects
An open label phase 2 trial to evaluate safety, tolerability and immunogenicity of the ABNCoV2 vaccine after intramuscular (IM) application.
- Trial name
- NCT05077267
- Testing
- ABNCoV2 100ug, ABNCoV2 50ug
- Where
- 2 sites in Germany
- Volunteers
- 197 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Helicobacter Pylori Infected Subjects, Helicobacter Pylori Naive Subjects
Phase 1a/b Study on Safety of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers
A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected healthy volunteers.
- Trial name
- IMX-02 (NCT03270800)
- Testing
- CTA control, IMX101 vaccine
- Where
- 2 sites in Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- ImevaX
Pneumococcal Infectious Disease
Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older .
- Trial name
- NCT06678607
- Testing
- Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2, PPSV23
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Reinovax Biologics Co., LTD
Healthy Subjects
Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949
This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending single oral dose and food interaction Phase 1 study.
- Trial name
- NCT02099071
- Testing
- ACT-389949 1 mg, ACT-389949 5 mg, ACT-389949 20 mg
- Where
- Netherlands
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME)
Study of JMKX003948 Ophthalmic Suspension in Healthy Participants
The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants.
- Trial name
- NCT06832657
- Testing
- JMKX003948 Ophthalmic Suspension
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Jemincare
Malaria
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir
The purpose of this study is to assess the effect of multiple doses of ganaplacide and lumefantrine combination on the substrates of cytochrome P450 (CYP) 3A4 (midazolam), CYP2C8 (repaglinide), CYP2D6 (dextromethorphan), organic…
- Trial name
- NCT05236530
- Testing
- Midazolam, Repaglinide, Dextromethorphan
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Safety and Pharmacokinetics in Healthy Volunteer Subjects
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the…
- Trial name
- AME/FE (NCT01611467)
- Testing
- CC-223
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Celgene
Major Depressive Disorder
Tolerability and Pharmacokinetics of Hypidone Hydrochloride in Healthy Subjects
This study will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old.
- Trial name
- NCT04598607
- Testing
- Hypidone Hydrochloride tablets
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Zhejiang Huahai Pharmaceutical Co., Ltd.
Respiratory Disorders
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057
GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of inhaled GSK1995057 in healthy subjects.
- Trial name
- NCT01587807
- Testing
- GSK1995057, bronchoalveolar lavage, LPS
- Where
- 2 sites in United Kingdom
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
MERS (Middle East Respiratory Syndrome)
Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S
The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) and currently…
- Trial name
- NCT03615911
- Testing
- vaccine candidate MVA-MERS-S
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Marylyn Addo
Healthy
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.
- Trial name
- NCT02372344
- Testing
- AZD0585
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pulmonary Disease, Chronic Obstructive
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of GSK573719 (LAMA) and GW642444 (LABA)Administered Individually and Concurrently in Healthy Japanese Subjects
GW642444 is a potent and selective long-acting beta2 agonist; GSK573719 is a long-acting, inhaled, muscarinic receptor antagonist (or anticholinergic) bronchodilator.
- Trial name
- DB2113208 (NCT00976144)
- Testing
- GSK573719
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Coronary Syndrome
Study of LC23-1306 in Healthy Male Subjects
This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic/pharmacodynamic characteristics.
- Trial name
- NCT01526577
- Testing
- LC23-1306, Ticagrelor
- Where
- South Korea
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
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