Clinical trials: Tolerability
Pneumococcal Infections
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00452790
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 12 sites in India
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Volunteers
Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects
This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.
- Trial name
- NCT05387668
- Testing
- BGB-23339
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- BeiGene
Malaria,Falciparum
Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of TB31F
This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or subcutaneously at escalating dose levels in healthy, malaria naïve, adults.
- Trial name
- TB31F (NCT04238689)
- Testing
- TB31F
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Vaccine
Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"
Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI…
- Trial name
- NCT05715918
- Testing
- Vaccine for intramuscular injection
- Where
- 4 sites in Russia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Healthy
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.
- Trial name
- NCT04621318
- Testing
- Denosumab
- Where
- 2 sites in United States, France
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
COVID-19 Vaccine, Safety Issues
ChulaCov19 Vaccine in Healthy Adults
This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants.
- Trial name
- NCT04566276
- Testing
- ChulaCov19 vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Chulalongkorn University
Healthy Subjects
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016
This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and it's effect on the body in Japanese male subjects.
- Trial name
- NCT00740649
- Testing
- HSD-016
- Where
- Japan
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Dose Finding Study
Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers.
This is a phase I, randomized, single-blind, parallel group, placebo-controlled, multi-cohort, first-in-human dose escalation study of a single IV 3-hour administration of Cilastatin as stand-alone in healthy male and female…
- Trial name
- NCT03595189
- Testing
- Cilastatin
- Where
- Spain
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Spherium Biomed
Healthy Volunteer
A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this trial is to investigate brain activity, safety, tolerability, and PK of multiple…
- Trial name
- NCT07050368
- Testing
- Psilocybin
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Healthy Participants
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy Japanese study participants
- Trial name
- NCT07286682
- Testing
- UCB5285
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy Volunteers
A Study to Investigate the Safety of AB680 in Healthy Volunteers
This is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetic profile of AB680 in healthy volunteers.
- Trial name
- NCT03677973
- Testing
- AB680
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Arcus Biosciences, Inc.
Rheumatoid Arthritis
Study of LFD-200 in Healthy Adults and Adults With Moderate to Severe Rheumatoid Arthritis
This is a double-blind, randomized, placebo- and active-controlled study investigating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) doses of LFD-200.
- Trial name
- NCT07207954
- Testing
- LFD-200, Oral Prednisone
- Where
- 10 sites in Australia, Georgia and 3 more
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- Lifordi Immunotherapeutics, Inc.
Non-alcoholic Steatohepatitis
The Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of HEC88473 in Healthy Subjects
A Phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of HEC88473 in healthy subjects
- Trial name
- NCT04829123
- Testing
- HEC88473 injection
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Healthy
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
- Trial name
- SNO2 (NCT02013388)
- Testing
- N91115
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Nivalis Therapeutics, Inc.
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
- Trial name
- NCT04670796
- Testing
- HLX02, EU-sourced Trastuzumab (Herceptin®), US-licensed Trastuzumab (Herceptin®)
- Where
- China
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Plaque Psoriasis
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)
This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis.
- Trial name
- NCT01140061
- Testing
- MK-0873 Patch, MK-0873 Cream, Plain patch
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Ebola Virus
Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults
RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola vaccine in healthy adults.
- Trial name
- NCT04041570
- Testing
- cAd3-EBO S vaccine
- Where
- Uganda
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acute Kidney Injury
PK and PD of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral doses over 14 days to healthy obese male volunteers.
- Trial name
- NCT02460146
- Testing
- CXA-10
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Complexa, Inc.
Cystic Fibrosis
A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants
This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants.
- Trial name
- NCT03173573
- Testing
- FDL176
- Where
- 3 sites in Australia
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Flatley Discovery Lab LLC
Healthy Volunteers
A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers
A new immunosuppressive drug, based on the inhibition of important enzymes in the immune system, called JAK, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00860496
- Testing
- CP- 690,550 and Tacrolimus, CP- 690,550 and Cyclosporine
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
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