Clinical trials: Evaluate the Safety and Tolerability
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
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
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
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
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
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.
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
Community-acquired Infection
A Study to Evaluate Single and Repeat Doses of IV GSK2251052 in Healthy Male Japanese and Caucasian Subjects and Repeat Doses of Supratherapeutic Doses of IV GSK2251052 in Healthy Volunteers
This is a two-part study. Part A is a three-period study in approximately 24 healthy male Japanese and Caucasian subjects. Period 1 and Period 2 will be an open label study to investigate the safety, tolerability, and…
- Trial name
- NCT01495065
- Testing
- GSK2251052 750 mg, GSK2251052 1500 mg, GSK2251052 1500 mg BID
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.
- Trial name
- ENLIVEN (NCT04929483)
- Testing
- BIO89-100
- Where
- 89 sites in United States, Puerto Rico
- Volunteers
- 222 people
- Sponsor
- 89bio, Inc.
Solid Tumor, Lymphoma
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
- Trial name
- NCT05357651
- Testing
- LB1410
- Where
- China
- Volunteers
- 100 people
- Sponsor
- L & L Bio Co., Ltd., Ningbo, China
Knee Osteoarthritis
Phase Ib Trial of Injectable RAB001 for Knee Osteoarthritis
This is a randomized, double-blind, placebo-controlled dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of intra-articular injection of RAB001 in participants…
- Trial name
- LBRC_RAB001_OA (NCT07652372)
- Testing
- RAB001 medium dose
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- ZhongShan LaiBo RuiChen BioMedicine Co.,Ltd.
Advanced Solid Malignancies
Evaluate Safety, Tolerability, PK, Preliminary Clinical Activity of OB318 in Patients With Advanced Solid Malignancies
The objectives of this Phase I study are to determine the maximum tolerable dose (MTD) and to evaluate pharmacokinetics (PK), safety/ tolerability and preliminary efficacy of OB318 in patients with advanced solid malignancies.
- Trial name
- NCT02347228
- Testing
- OB318 capsule
- Where
- 2 sites in Taiwan
- Volunteers
- 21 people
- Sponsor
- Oneness Biotech Co., Ltd.
Locally Advanced or Metastatic Solid Tumors
A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors
This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in…
- Trial name
- NCT06349811
- Testing
- BL-M05D1
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Chronic Obstructive Pulmonary Disease (COPD)
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential.
- Trial name
- NCT01754844
- Testing
- AZD7624
- Where
- United Kingdom
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Transplantation
This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.
- Trial name
- NCT00531063
- Testing
- Everolimus (RAD001)
- Where
- Switzerland
- Volunteers
- 237 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin
Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and…
- Trial name
- NCT02206087
- Testing
- PER977, Heparin Sodium
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Stasis Dermatitis
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment…
- Trial name
- NCT04091087
- Testing
- crisaborole ointment, vehicle ointment
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- Pfizer
Alzheimer's Disease (AD)
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
This study is to be conducted in participants with early Alzheimer's Disease to test VY7523, a new drug being researched for treatment of Alzheimer's Disease.
- Trial name
- NCT06874621
- Testing
- VY7523
- Where
- 23 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Voyager Therapeutics
Depressive Disorder, Treatment-Resistant
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either…
- Trial name
- TRANSFORM-3 (NCT02422186)
- Testing
- Esketamine, Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant)
- Where
- 69 sites in United States, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Janssen Research & Development, LLC
Duchenne Muscular Dystrophy
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
RGX-202 is a gene therapy designed to deliver a transgene for a novel microdystrophin that includes functional elements of naturally-occurring dystrophin including the C-Terminal (CT) domain.
- Trial name
- NCT05693142
- Testing
- RGX-202
- Where
- 23 sites in United States, Canada
- Volunteers
- 65 people
- Sponsor
- REGENXBIO Inc.
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