Clinical trials: Tolerability
Alzheimer Disease
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease
The main purpose of this study is to assess how well Donanemab is tolerated and what side effects may occur in Indian participants with early symptoms of Alzheimer's Disease (AD).
- Trial name
- NCT07838155
- Testing
- Donanemab
- Where
- 12 sites in India
- Volunteers
- 50 people
- Sponsor
- Eli Lilly and Company
Metastatic Gastric Cancer
Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction…
- Trial name
- NCT06008925
- Testing
- Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)), Nivolumab Injection
- Where
- China
- Volunteers
- 43 people
- Sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd.
Healthy Participants
A Study to Assess the Safety and Tolerability of Single and Multiple Ascending Doses of Oral RO7020531 in Chinese Healthy Participants.
To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.
- Trial name
- NCT03530917
- Testing
- RO7020531
- Where
- Hong Kong
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Metastatic Renal Cell Carcinoma, Metastatic Malignant Melanoma
Study of AS1409 in Patients With Either Metastatic Renal Cell Carcinoma or Metastatic Malignant Melanoma
To determine the tolerability, safety, end-organ toxicity and maximum tolerated dose of AS1409 in single and repeated doses.
- Trial name
- NCT00625768
- Testing
- AS1409
- Where
- 4 sites in New Zealand, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Antisoma Research
Liver Cirrhosis, Sarcopenia
A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.
- Trial name
- NCT04874350
- Testing
- LPCN 1148
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Lipocine Inc.
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 Are Tolerated and Act in the Body in Healthy Adults
This study has two parts: Part A and Part B. The purpose of Part A of this study is to learn about the safety, tolerability, and how PF-07328948 is processed by the body when multiple doses of PF-07328948 are given to healthy…
- Trial name
- NCT05807490
- Testing
- PF-07328948
- Where
- 2 sites in United States, Belgium
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Pfizer
Major Depressive Disorder (MDD)
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an…
- Trial name
- NCT01111552
- Testing
- Escitalopram, Aripiprazole
- Where
- 60 sites in United States, Australia and 5 more
- Volunteers
- 237 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Dry Eye Disease
A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease
The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.
- Trial name
- ISV-101 (NCT01478555)
- Testing
- ISV 101
- Sponsor
- Sun Pharmaceutical Industries Limited
Depressive Disorder, Major
A Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the efficacy of flexibly dosed JNJ-42847922 (20 milligram [mg] or 40 mg) compared to flexibly dosed quetiapine extended-release (XR) (150 mg or 300 mg) as adjunctive therapy to an…
- Trial name
- NCT03321526
- Testing
- JNJ-42847922, Quetiapine XR, Selective Serotonin Reuptake Inhibitor (SSRI)
- Where
- 50 sites in United States
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Solid Tumours
Safety Study of SLC-0111 in Subjects With Advanced Solid Tumours
SLC-0111 is a selective, small molecule, inhibitor of carbonic anhydrase (CA) IX and is in development for the treatment of solid tumours over-expressing CA IX.
- Trial name
- NCT02215850
- Testing
- SLC-0111
- Where
- 3 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Welichem Biotech Inc.
Non-Small Cell Lung Cancer, Lung Cancer
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation…
- Conditions
- Non-Small Cell Lung Cancer, Lung Cancer, NSCLC, NSCLC (Non-small Cell Lung Carcinoma)
- Trial name
- NCT06685718
- Testing
- BG-60366
- Where
- 29 sites in United States, Australia and 5 more
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Acute-graft-versus-host Disease, aGVHD
A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of EQ001 in subjects with Acute Graft Versus Host Disease (aGVHD).
- Conditions
- Acute-graft-versus-host Disease, aGVHD, GVHD, GVHD, Acute
- Trial name
- EQUATE (NCT03763318)
- Testing
- EQ001
- Where
- 16 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biocon Limited
Non-Small Cell Lung Cancer
Safety, Tolerability and Pharmacokinetic Profile of BPI-15086 in EGFR T790M Mutation-positive NSCLC Patients
The main objective of this study is to evaluate the safety and tolerability of BPI-15086.
- Trial name
- NCT02914990
- Testing
- BPI-15086
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Systemic Lupus Erythematosus, Healthy Volunteers
Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus
The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a…
- Trial name
- NCT02106897
- Testing
- BIIB059 (litifilimab)
- Where
- 5 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Biogen
Primary Axillary Hyperhidrosis
Assessment of Safety, Tolerability and Efficacy of 1% GPB Cream Versus Qbrexza® (Glycopyrronium) Cloth 2.4% Under Maximum-Use Conditions in Subjects with Primary Axillary Hyperhidrosis
The aim of this study is to investigate the safety, tolerability and efficacy of 1% GPB Cream compared to Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.
- Trial name
- NCT04159610
- Testing
- WO3970, Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Phenylketonuria
GenSci144 Tablets Phase I Clinical Trial
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels.
- Trial name
- NCT07685210
- Testing
- GenSci144 tablets
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Gout, Acute Gout Flare
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers
A randomized, double-blind, placebo-controlled, dose-escalation study will be conducted in healthy volunteers. This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ABP-745 following single (Part 1) and…
- Conditions
- Gout, Acute Gout Flare, Gout Flares
- Trial name
- ABP-745 (NCT06258213)
- Testing
- ABP-745
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Atom Therapeutics Co., Ltd
Bladder Cancer TNM Staging Primary Tumor (T) T2, Bladder Cancer TNM Staging Primary Tumor (T) T2A
Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for…
- Conditions
- Bladder Cancer TNM Staging Primary Tumor (T) T2, Bladder Cancer TNM Staging Primary Tumor (T) T2A, Bladder Cancer TNM Staging Primary Tumor (T) T2B, Bladder Cancer TNM Staging Primary Tumor (T) T3
- Trial name
- NCT03518320
- Testing
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200, Nivolumab Injection [Opdivo]
- Where
- 6 sites in United States
- Volunteers
- 13 people
- Sponsor
- Taris Biomedical LLC
Muscular Dystrophy, Oculopharyngeal (OPMD)
Continuation Protocol to Protocol BBCO-001
This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized…
- Trial name
- HOPEMD (NCT02328482)
- Testing
- Tehalose 30gr
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- Bioblast Pharma Ltd.
Healthy Volunteers
Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994
This is a double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study will be conducted in 2 parts: a single ascending dose (SAD) part, followed by a multiple ascending dose (MAD) part.
- Trial name
- NCT03395249
- Testing
- SPR994, Orapenem®
- Where
- Australia
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics