Clinical trials: Safety and Tolerability
Urinary Tract Infections
Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections
Urinary tract infections (UTIs) are among the most common bacterial infections in children. Up to 50% of UTI's are caused by multi-drug resistant ESBL-producing gram negative bacteria that do not respond to treatment with oral…
- Trial name
- FosUTI (NCT05709028)
- Testing
- Fosfomycin, Standard of care antibiotics
- Where
- 5 sites in Australia
- Volunteers
- 300 people
- Sponsor
- University of Sydney
Healthy Adult Subjects
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05.
- Trial name
- NCT05632211
- Testing
- AVT05, Simponi
- Where
- 2 sites in New Zealand, United Kingdom
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Adult Onset Still's Disease
A Study to Evaluate Camoteskimab in Participants With Still's Disease
The main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease.
- Trial name
- NCT04752371
- Testing
- Camoteskimab (CERC-007, AVTX-007, AEVI-007)
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 5 people
- Sponsor
- Apollo Therapeutics Ltd
Advanced KRAS G12D Mutant Solid Tumors
Phase I Study of HRS-6093 in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutations
This is an open-label, multi-center phase I clinical study to evaluate HRS-6093 Safety, Tolerability, and Pharmacokinetics in Participants harboring KRAS G12D Mutations with advanced solid tumors.
- Trial name
- NCT07134998
- Testing
- HRS-6093
- Where
- 2 sites in China
- Volunteers
- 153 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Clostridium Difficile-associated Diarrhea
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT01591863
- Testing
- fidaxomicin
- Volunteers
- 38 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Respiratory Syncytial Virus Infections
A Dose Finding Study of VN-0200
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
- Trial name
- NCT05547087
- Testing
- VN-0200
- Where
- 3 sites in Japan
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
HIV Infections
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with…
- Trial name
- NCT00000893
- Testing
- Nelfinavir mesylate, Efavirenz
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 103 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Lung Injury, Acute Respiratory Distress Syndrome
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
- Trial name
- NCT00789685
- Testing
- Interferon Beta
- Where
- 8 sites in United Kingdom
- Volunteers
- 37 people
- Sponsor
- Faron Pharmaceuticals Ltd
Asthma
A Study to Investigate the Safety, Tolerability and Effects of AZD8630 in Healthy Subjects and Subjects With Asthma on Inhaled Corticosteroids and Long-acting Beta-agonists
This is a first in human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8630 in healthy adults (Part A) and adult asthma patients on medium to high dose inhaled…
- Trial name
- NCT05110976
- Testing
- AZD8630
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
SARS-CoV-2 Infection
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects.
- Trial name
- NCT05017168
- Testing
- CT-P63
- Where
- Poland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Celltrion
Pneumococcal Infection
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.
- Trial name
- NCT00560950
- Testing
- pneumococcal 23v polysaccharide vaccine
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pulmonary Disease, Chronic Obstructive
Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects
GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases.
- Trial name
- NCT03189589
- Testing
- GSK2269557 500 µg, GSK2269557 750 µg
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Bacterial Skin and Skin Structure Infection (ABSSSI), Prosthetic Joints Infection (PJI)
Phase 1, Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants
This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.
- Trial name
- NCT06394518
- Testing
- TNP-2092 for injection
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics Inc.
Asthma
A Study of RO5036505 in Patients With Moderate to Severe Asthma
This randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of RO5036505 in patients with inadequately controlled moderate to severe asthma.
- Trial name
- NCT00967590
- Testing
- RO5036505
- Where
- 16 sites in United States, United Kingdom
- Sponsor
- Hoffmann-La Roche
Healthy
Safety, Tolerability, and Pharmacokinetics of BI 201335 NA in Healthy Male Subjects
The objective of this trial was to investigate safety, tolerability, and pharmacokinetics of BI 201335 ZW after administration of single rising doses from 40 mg to 480 mg of BI 201335 NA in healthy Japanese male volunteers.
- Trial name
- NCT02182297
- Testing
- BI 201335 NA in single rising doses
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Single-Dose Study of the Safety and Tolerability of REGN475(SAR164877) in Healthy Subjects
This is a randomized, double-blind, placebo-controlled single-dose study of the safety and tolerability of intravenously administered REGN475 in healthy volunteers.
- Trial name
- NCT00856310
- Testing
- REGN475 (SAR164877)
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Urinary Tract Infection
Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9…
- Trial name
- NCT01014013
- Testing
- ertapenem sodium (MK0826), Comparator: ceftriaxone sodium
- Volunteers
- 271 people
- Sponsor
- Merck Sharp & Dohme LLC
COVID-19
Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)
This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older.
- Trial name
- NCT04636333
- Testing
- Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28, Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14
- Where
- China
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Solid Tumours
A Study to Test How Well Different Doses of BI 3822971 Are Tolerated by People With Advanced Cancer (Solid Tumours)
This study is open to adults with advanced or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer…
- Trial name
- NCT07744152
- Testing
- BI 3822971
- Where
- 11 sites in Belgium, China and 3 more
- Volunteers
- 137 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C
Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)
This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese participants with chronic hepatitis C virus (HCV) genotype 1 (GT1).
- Trial name
- NCT02203149
- Testing
- Grazoprevir, Elbasvir
- Volunteers
- 399 people
- Sponsor
- Merck Sharp & Dohme LLC
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