Clinical trials: Safety and Tolerability
Healthy
A Multiple Increasing Dose Safety and Tolerability Study After Inhalation Administration of BIIX 1 XX in Healthy Male Volunteers
The objective of the present study is to obtain information about the safety and tolerability of multiple increasing doses of BIIX 1 XX and to obtain preliminary pharmacokinetic data
- Trial name
- NCT02198313
- Testing
- BIIX 1 XX - D1, BIIX 1 XX - D2, BIIX 1 XX - D3
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled XQ-001 in Healthy Subjects
The primary study objective is to evaluate the safety and tolerability of XQ-001 for inhalation after single and multiple nebulized inhalation administration in healthy Chinese adult subjects.
- Trial name
- NCT06918366
- Testing
- Part A - single rising dose 1, Part A - single rising dose 2, Part A - single rising dose 3
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Brilliant Inspiration Biotherapeutics
Alzheimer Disease
Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production
This is a Phase I, single center, open label, multiple dose, pharmacokinetic (PK) study recruiting healthy older subjects.
- Trial name
- NCT04268953
- Testing
- Tricaprilin
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cerecin
Addiction
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy…
- Trial name
- NCT04292197
- Testing
- 18-MC Compound
- Where
- Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Definium Therapeutics US, Inc.
Amyotrophic Lateral Sclerosis (ALS)
A First in Human Study of ORT247 in Healthy Volunteers
This is a single center, double-blinded, randomized, placebo controlled single ascending dose clinical study, with the primary purpose of evaluating the safety, tolerability, pharmacokinetics (PK), and immunohistochemistry of…
- Trial name
- NCT06769620
- Testing
- ORT247
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Orthogonal Neuroscience Inc.
Parkinson Disease
Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509.
- Trial name
- NCT01691924
- Testing
- PBF-509
- Where
- 2 sites in Spain
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Ascending Single Dose Study
Safety, Tolerability and Pharmacokinetics of TAK-438 in Healthy Male Participants
The primary purpose of this study was to evaluate the single dose safety and pharmacokinetics of TAK-438 in healthy Japanese men.
- Trial name
- NCT02123927
- Testing
- TAK-438
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Takeda
Elevated Low-Density Lipoprotein Cholesterol
Dose Escalation of SNK-396 in Participants With Elevated Low-Density Lipoprotein Cholesterol
This is a Phase 1, multi-center, randomized, double-blinded, placebo-controlled single and multiple dose escalation study with SC doses of SNK-396 in participants with elevated LDL-C.
- Trial name
- NCT05896969
- Testing
- SNK-396 - SAD cohort, SNK-396 - MAD Cohort
- Where
- 3 sites in Australia
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Healthy
Study Evaluating LXR-623 in Healthy Subjects
To evaluate the safety and tolerability of a single dose of LXR-623 in healthy subjects.
- Trial name
- NCT00366522
- Testing
- LXR-623
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Alzheimer Disease
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Donepezil From Single Dose of GB-5001 IM Depot and Aricept® Oral Tablets in Healthy Male Volunteers
This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM depot in healthy male volunteers.
- Trial name
- NCT05525780
- Testing
- GB-5001, Oral cohort
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- G2GBio, Inc.
Clostridium Difficile Associated Disease
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine.
- Trial name
- NCT02117570
- Testing
- Clostridium difficile vaccine
- Where
- 12 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Pfizer
Vaccines, Pneumococcal
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations…
- Trial name
- NCT00368966
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7-valent Pneumococcal Conjugate Vaccine
- Where
- 41 sites in Spain
- Volunteers
- 619 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Influenza A
Safety, Tolerability, Efficacy and Immunogenicity of an Influenza A Vaccine (FP-01.1) in Healthy Volunteers Following Virus Challenge
The purpose of this study is to assess the safety, tolerability, efficacy, and immunogenicity of an influenza A vaccine (vaccine: FP-01.1), as compared to placebo, in healthy volunteers following a dose of influenza A virus.
- Trial name
- NCT02071329
- Testing
- Vaccine FP-01.1, Virus Challenge
- Where
- United Kingdom
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Immune Targeting Systems Ltd
Overweight and Obesity
A Phase 1, Double-blind, Randomized Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Single Dose and Multiple Doses of CG-0416 in Healthy Participants.
A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co.
- Trial name
- NCT07724431
- Testing
- CG-0416
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- HongKong Curegene Innovation Co., Limited
Obesity and Obesity-related Medical Conditions
A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.
- Trial name
- NCT06924320
- Testing
- MET233 and MET097, MET097
- Where
- United States
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Pfizer
Parkinson Disease Psychosis, Amyotrophic Lateral Sclerosis (ALS)
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
- Trial name
- NCT05995782
- Testing
- FB418
- Where
- South Korea
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- 1ST Biotherapeutics, Inc.
COVID-19
A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198
This is a phase 1 study in which healthy adult volunteers will receive BRII-196/BRII-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.
- Trial name
- NCT04691180
- Testing
- BRII-196 and BRII-198
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Brii Biosciences Limited
Endometriosis
BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect
This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065
- Trial name
- NCT03427788
- Testing
- BAY2328065
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Intravenous Doses of NH302 Injection in Healthy Participants
This is a first-in-human study of NH302 injection in healthy participants. The study will test single intravenous doses of NH302 to evaluate its safety and tolerability, how the body processes NH302, and its effects on selected…
- Trial name
- NCT07892469
- Testing
- NH302 injection
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- The Third Xiangya Hospital of Central South University
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