Clinical trials: Tolerability
Healthy
A Study of LY3463251 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
- Trial name
- NCT03764774
- Testing
- LY3463251
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Healthy
A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
- Trial name
- NCT06716190
- Testing
- Mid-dose bid BI 3731579, Midazolam, Low-dose bid BI 3731579
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
This randomized study will evaluate the safety, tolerability and pharmacokinetics of single ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
- Trial name
- NCT03505190
- Testing
- RO7062931
- Where
- 2 sites in Hong Kong
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Covid19, Severe Acute Respiratory Syndrome
Safety and Tolerability of COVID-19 Vaccine (ABNCoV2)
This phase 1 trial aims to assess the safety and tolerability of two doses of ABNCoV2, formulated with and without the adjuvant MF59, in healthy adult volunteers and to identify the dosage and formulation that optimizes the…
- Conditions
- Covid19, Severe Acute Respiratory Syndrome, SARS-CoV-2 Infection
- Trial name
- COUGH-1 (NCT04839146)
- Testing
- ABNCoV2 Vaccine
- Where
- Netherlands
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Pharmacokinetics, Cancer
Safety, Tolerability and Pharmacokinetics Study of MK-7252 in Healthy Adult Participants (MK-7252-001)
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of MK-7252 in healthy adults. Participants receive ascending doses of MK-7252 over five treatment periods.
- Trial name
- NCT03326986
- Testing
- MK-7252
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
This Study Tests the Safety, Tolerability and How Different Doses of BI 1265162 Are Taken up in the Body of Healthy Men
The primary objective of this trial is to investigate the safety and tolerability of BI 1265162 in healthy male subjects following inhalative administration of single rising doses.
- Trial name
- NCT03349723
- Testing
- BI 1265162
- Where
- Germany
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Orthopoxviral Disease
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers.
- Trial name
- 246-Safety (NCT00907803)
- Testing
- ST-246 400 mg, ST-246 600 mg
- Where
- 3 sites in United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Nasolabial Folds
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
- Trial name
- NCT00797459
- Testing
- Restylane and Restylane-L
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Medicis Global Service Corporation
Healthy Subjects, Pneumococcal Infections
Study Evaluating Pneumococcal Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
- Trial name
- NCT00205803
- Testing
- 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
- Where
- United States
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Diarrhea
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
This is a research study about an experimental (investigational) oral ETEC vaccine (ACE527). ACE527 is a live attenuated vaccine that is being made to prevent disease from enterotoxigenic Escherichia coli (ETEC), which causes…
- Trial name
- NCT01739231
- Testing
- ACE527, dmLT, H10407 challenge strain
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- PATH
Hemorrhagic Fever, Ebola
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and…
- Trial name
- NCT02598388
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 7 sites in United States, Kenya and 4 more
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Healthy
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in…
- Trial name
- NCT05285137
- Testing
- CD388 Injection
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Marburg Virus Disease
cAd3-Marburg Vaccine in Healthy Adults
RV 507 was a Phase I, open-label study to examine the safety, tolerability and immunogenicity of an investigational Marburg vaccine given by intramuscular (IM) injection to healthy adults.
- Trial name
- NCT03475056
- Testing
- cAd3-Marburg vaccine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pneumococcal Infections
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™.
- Trial name
- PNEU-AGE (NCT03950622)
- Testing
- V114, Prevnar 13®
- Where
- 30 sites in United States, Canada and 3 more
- Volunteers
- 1,205 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Group B Streptococcus Infections
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with…
- Trial name
- NCT04766086
- Testing
- Multivalent Group B streptococcus vaccine, Tetanus, diphtheria, and acellular pertussis vaccine
- Where
- 12 sites in United States
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- Pfizer
Vaccines, Pneumococcal Conjugate Vaccine
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to…
- Trial name
- NCT00500357
- Testing
- 13-valent Pneumococcal Conjugate Vaccine
- Where
- 16 sites in South Africa
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Comparison of Octaplas LG and Octaplas SD
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters.
- Trial name
- NCT01063595
- Testing
- Octaplas LG, Octaplas SD
- Where
- Austria
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Octapharma
Plague, Pneumonic, Plague
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
- Conditions
- Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
- Trial name
- NCT05506969
- Testing
- rF1V-1018, rF1V vaccine
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Healthy Volunteers
A Study of LY3053102 in Healthy Participants
The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants.
- Trial name
- NCT01736241
- Testing
- LY3053102
- Where
- Singapore
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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