Clinical trials: Tolerability
Solid Tumor (Phase I)
A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration
This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
- Trial name
- NCT07718165
- Testing
- ABSK211
- Where
- China
- Volunteers
- 247 people
- Sponsor
- Abbisko Therapeutics Co, Ltd
Influenza
Phase 1b Influenza Vaccine Study in Healthy Subjects
The purpose of this study is to see whether a single vaccination (injection) with the investigational influenza vaccine is safe in healthy subjects.
- Trial name
- NCT01181336
- Testing
- Influenza vaccine (FLU-v), FLU-v Control
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- PepTcell Limited
Advanced Solid Tumor
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid…
- Trial name
- NCT07414836
- Testing
- BG-C0979, Tislelizumab
- Where
- 18 sites in United States, Australia and 2 more
- Volunteers
- 84 people
- Sponsor
- BeOne Medicines
Advanced Malignancies, Tumors
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
- Trial name
- NCT00421044
- Testing
- Patupilone/EPO906
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Stunting of Growth, Chronic Malnutrition
Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala
The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala.
- Trial name
- NCT07804667
- Testing
- Modified Therapeutic Food Formulation, Nutri Listo SQ-LNS
- Where
- Guatemala
- Volunteers
- 36 people
- Sponsor
- Wuqu' Kawoq, Maya Health Alliance
Healthy
The Safety and Tolerability of STSA-1002 Following Intravenous Infusion in Healthy Subjects
A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects
- Trial name
- NCT05032144
- Testing
- STSA-1002 injection
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Papillomavirus Infections
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.
- Trial name
- NCT00380367
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Renal Transplantation
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients.
- Trial name
- NCT00400400
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil
- Where
- 53 sites in United States
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms
BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer
The purpose of this study is to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.
- Trial name
- NCT00962611
- Testing
- Copanlisib (Aliqopa, BAY80-6946)
- Where
- 3 sites in United States
- Volunteers
- 57 people
- Sponsor
- Bayer
Neoplasms
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin.
- Trial name
- NCT00421811
- Testing
- ADH-1, melphalan
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Adherex Technologies, Inc.
Healthy
Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects
This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051.
- Trial name
- NCT00409500
- Testing
- AQW051
- Where
- Japan
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis
Congenital Bleeding Disorder, Haemophilia A
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.
- Trial name
- alleviate 1 (NCT02994407)
- Testing
- turoctocog alfa pegol
- Where
- 19 sites in United States, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Infertility
Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA
Purpose of the study is the evaluation of the tolerability (both local and systemic) and the clinical efficacy (in terms oocytes recovered) of subcutaneously versus intramuscularly administered Merional® (IBSA, Lugano - CH) in…
- Trial name
- NCT00464607
- Testing
- hMG-IBSA, Ovarian stimulation
- Where
- 4 sites in Italy
- Volunteers
- 160 people
- Sponsor
- IBSA Institut Biochimique SA
Type 2 Diabetes
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
This study will assess, over a 4-week treatment period, the safety and efficacy of the addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who failed to achieve glycemic control on metformin…
- Trial name
- NCT01034111
- Testing
- Sitagliptin phosphate, Metformin
- Volunteers
- 30 people
- Sponsor
- Merck Sharp & Dohme LLC
Schizophrenia
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
- Trial name
- NCT03150771
- Testing
- Aripiprazole
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pompe Disease
First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221
This is an international, multi-center, open-label study designed to evaluate if the co-administration of investigational new drugs ATB200 and AT2221 is safe in adults with Pompe disease.
- Trial name
- NCT02675465
- Testing
- ATB200, AT2221
- Where
- 19 sites in United States, Australia and 4 more
- Volunteers
- 29 people
- Sponsor
- Amicus Therapeutics
Cervical Cancer
A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer
This is an open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3112 DNA vaccines delivered by electroporation (EP) to female participants with HPV-16 and/or 18-positive cervical carcinoma.
- Trial name
- NCT02172911
- Testing
- INO-3112, CELLECTRA™-5P
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Inovio Pharmaceuticals
Advanced Cancer, Advanced Malignancies
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers
The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.
- Conditions
- Advanced Cancer, Advanced Malignancies, Bladder Cancer, Cervical Cancer
- Trial name
- ARC-25 (NCT05891171)
- Testing
- AB598, Zimberelimab, Fluorouracil
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 40 people
- Sponsor
- Arcus Biosciences, Inc.
Management of Moderate to Severe Pain
Pharmacokinetics Study of ALO-02 and OxyContin
To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers
- Trial name
- NCT01557257
- Testing
- ALO-02, Naltrexone block, OxyContin
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hematologic Diseases, Anaemia, Sickle Cell
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Oral GSK4172239D Compared With Placebo in Sickle Cell Disease Participants Aged 18 to 50 Years
This will be a first time in human (FTIH) study in sickle cell diseases (SCD) participants. The FTIH study is planned to evaluate the safety, tolerability, and pharmacokinetics of GSK4172239D.
- Trial name
- NCT05660265
- Testing
- GSK4172239D
- Where
- 6 sites in United States
- Volunteers
- 11 people
- Sponsor
- GlaxoSmithKline
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