Clinical trials: Tolerability
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
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
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
Turner's Syndrome
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks
- Trial name
- NCT00250250
- Testing
- ZOMACTON
- Where
- 6 sites in Czechia, France and 1 more
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
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.
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
Healthy Volunteers
A Study of LY3006072 in Healthy Participants
The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body…
- Trial name
- NCT01640249
- Testing
- LY3006072
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
SARS CoV 2 Infection
A Study of EDP-235 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.
- Trial name
- NCT05246878
- Testing
- EDP-235
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
AD
A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT07693738
- Testing
- SSGJ-716
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Hereditary Hemorrhagic Telangiectasia
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
The purpose of this study is to: evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers evaluate the efficacy, safety, tolerability and PD of…
- Trial name
- InsigHHT (NCT06659640)
- Testing
- ALN-6400
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Healthy
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3.
- Trial name
- NCT01468558
- Testing
- MAP0004, IV DHE, Ketoconazole
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allergan
Healthy Participants
A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.
- Trial name
- NCT03530917
- Testing
- RO7020531
- Where
- Hong Kong
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy…
- Trial name
- NCT05807490
- Testing
- PF-07328948
- Where
- 2 sites in United States, Belgium
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Pfizer
Systemic Lupus Erythematosus, Healthy Volunteers
Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a…
- Trial name
- NCT02106897
- Testing
- BIIB059 (litifilimab)
- Where
- 5 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Biogen
Phenylketonuria
GenSci144 Tablets Phase I Clinical Trial
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels.
- Trial name
- NCT07685210
- Testing
- GenSci144 tablets
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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