Clinical trials: Dose Escalation and Safety
Inflammation, Rheumatoid Arthritis
First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single…
- Trial name
- NCT00927927
- Testing
- NNC0142-0002
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Janssen Research & Development, LLC
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts.
- Trial name
- NCT02712905
- Testing
- INCB059872, all-trans retinoic acid (ATRA), azacitidine
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 116 people
- Sponsor
- Incyte Corporation
Ebola Hemorrhagic Fever
Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.
- Trial name
- NCT01353027
- Testing
- AVI-6002
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Sarepta Therapeutics, Inc.
Melanoma
A Trial of Tigilanol Tiglate in Combination With Pembrolizumab in Stage IIIB to IV M1c-melanoma
A Phase Ib/IIa, multicentre, open label, dose-escalation study to evaluate the safety, tolerability, and preliminary effectiveness of intratumoural tigilanol tiglate in combination with intravenous pembrolizumab in adult patients…
- Trial name
- NCT04834973
- Testing
- tigilanol tiglate, pembrolizumab
- Where
- 2 sites in Australia
- Volunteers
- 3 people
- Sponsor
- QBiotics Group Limited
Osteoarthritis, Knee
A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis
The purpose of this study is to determine the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint…
- Trial name
- NCT04875754
- Testing
- ICM-203
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- ICM Biotech Australia Pty Ltd.
Bipolar Disorder
GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers
This is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be a 2 part and 2 centre study.Part 1 will be…
- Trial name
- NCT00488566
- Testing
- GSK drug, Lamictal
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Biogen
Peritoneal Carcinomatosis, Peritoneal Metastases
Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer
The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase…
- Conditions
- Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Small Bowel Cancer
- Trial name
- PIPAC-NAL-IRI (NCT05277766)
- Testing
- PIPAC with Nal-IRI
- Where
- Belgium
- Volunteers
- 45 people
- Sponsor
- University Hospital, Ghent
Clinical Pharmacology
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.
- Trial name
- NCT03136666
- Testing
- Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bayer
Cancer, Non Small Cell Lung Cancer
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel
The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.
- Conditions
- Cancer, Non Small Cell Lung Cancer, Epithelial Ovarian Cancer
- Trial name
- NCT01000896
- Testing
- AZD0530, Carboplatin, paclitaxel
- Where
- 2 sites in Japan
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide.
- Trial name
- SUSTAIN SWITCH (NCT04287179)
- Testing
- Semaglutide
- Where
- 25 sites in United States, Austria and 2 more
- Sponsor
- Novo Nordisk A/S
Pancreatic Cancer
Vitamin E δ-Tocotrienol Multiple Dose in Healthy Subjects
The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of pancreatic cancer cells. Therefore, the investigators must determine the safety and tolerability of Vitamin E δ-Tocotrienol in healthy…
- Trial name
- NCT01450046
- Testing
- Vitamin E δ-Tocotrienol
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Advanced Solid Tumor, Head and Neck Squamous Cell Carcinoma
Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.
This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it…
- Trial name
- NCT03666273
- Testing
- Bapotulimab (BAY1905254), Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Bayer
Healthy
A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers.
- Trial name
- NCT01161069
- Testing
- PF-03049423
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer
Surgical Site Infection
DFA-02 in Patients Undergoing Colorectal Surgery
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and…
- Trial name
- NCT01496352
- Testing
- DFA-02
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Multiple Myeloma, Renal Impairment
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and…
- Trial name
- POM Renal (NCT01575925)
- Testing
- 4 mg Oral POM + 40 mg Oral DEX, 2 mg Oral POM + 40 mg Oral DEX
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Celgene
Cognition Disorders, Multiple Sclerosis
A Study of C105 on Cognitive Dysfunction in Persons With Multiple Sclerosis
The purpose of this study is to determine the safety and efficacy of C105 in treating the cognitive deficits that can occur due to multiple sclerosis.
- Trial name
- NCT00529581
- Testing
- C105
- Where
- 30 sites in United States
- Volunteers
- 150 people
- Sponsor
- Cognition Pharmaceuticals, LLC
Huntington Disease
The Safety and Tolerability Study With ER2001 Intravenous Injection in Adults With Early Manifest Huntington's Disease
This is an open label, dose escalation clinic trial of ER2001 intravenous injection to evaluate safety, tolerability and pharmacokinetics of ascending single and multiple doses of intravenously administered ER2001 in patients…
- Trial name
- NCT06024265
- Testing
- ER2001 injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- ExoRNA Bioscience
Relapse Multiple Myeloma, Multiple Myeloma
A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma
The purpose of this study is to evaluate the safety and tolerability of a single infusion of OPD5 before Autologous Stem Cell Transplant in patients with RRMM.
- Trial name
- COAST (NCT04918511)
- Testing
- OPD5
- Where
- 3 sites in Czechia
- Sponsor
- Oncopeptides AB
Allergic Asthma, Atopic Dermatitis
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
Phase 1 study to evaluate the safety of MEDI4212.
- Conditions
- Allergic Asthma, Atopic Dermatitis, Allergic Rhinitis, Healthy Volunteers
- Trial name
- NCT01544348
- Testing
- Omalizumab, MEDI4212 5 mg Subcutaneous, MEDI4212 15 mg Subcutaneous
- Where
- 7 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Advanced Solid Tumor
A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors
This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal…
- Trial name
- NCT06480240
- Testing
- OBI-992
- Where
- 8 sites in United States, Taiwan
- Volunteers
- 117 people
- Sponsor
- OBI Pharma, Inc
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