Clinical trials: Safety and Tolerability
Schizophrenia
Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole
This study will test the safety of an aripiprazole injection in subjects with schizophrenia that are currently taking oral antipsychotic medication other than aripiprazole.
- Trial name
- NCT01552772
- Testing
- Aripiprazole IM Depot
- Where
- 12 sites in United States
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Cutaneous Tumor, Malignant Solid Tumor
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
- Trial name
- NCT05727839
- Testing
- JCXH-211 Injection
- Where
- 2 sites in United States, China
- Volunteers
- 19 people
- Sponsor
- Immorna Biotherapeutics, Inc.
Inflammatory Bowel Disease (IBD)
Phase I Study of QLS1510 Tablets in Healthy Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
- Trial name
- NCT07760077
- Testing
- QLS1510 Tablets
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
Alzheimer's Disease
A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
The purpose of this study is to: Evaluate the safety and tolerability of intrathecal (IT) ALN-5288 in patients with Alzheimer's Disease (AD) Evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ALN-5288 after…
- Trial name
- NCT07214727
- Testing
- ALN-5288
- Where
- 13 sites in Canada, Netherlands and 2 more
- Volunteers
- 50 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy, Renal Insufficiency
Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
- Trial name
- NCT04154670
- Testing
- MGTA-145
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Ensoma
Pneumococcal Disease
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults…
- Trial name
- NCT07284654
- Testing
- 31 valent pneumococcal conjugate vaccine, PCV20, PCV21
- Where
- 30 sites in United States
- Volunteers
- 4,049 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Diabetes Mellitus
Safety and Tolerability of GX-G6 in Healthy Male Subjects
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male subjects receiving ascending single s.c. doses of GX-G6
- Trial name
- NCT03651466
- Testing
- Gx-G6
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Genexine, Inc.
Myelodysplastic Syndrome, Iron Overload
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
- Trial name
- NCT00110266
- Testing
- Deferasirox
- Where
- 48 sites in United States, Canada
- Volunteers
- 176 people
- Sponsor
- Novartis Pharmaceuticals
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0001)
This trial starts the clinical development of BI 1839100. Effects of single rising doses of BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further development in patients with pulmonary…
- Trial name
- NCT05354453
- Testing
- BI 1839100, allyl isothiocyanate (AITC)
- Where
- Netherlands
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants
The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
- Trial name
- NCT04569695
- Testing
- JNJ-70033093
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Neoplasms, Breast Cancer
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
To assess the safety and tolerability at increasing dose levels of PF-06650808 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
- Trial name
- NCT02129205
- Testing
- PF-06650808
- Where
- 11 sites in United States
- Volunteers
- 40 people
- Sponsor
- Pfizer
Focal Epilepsy
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
- Trial name
- RISE 3 (NCT06309966)
- Testing
- BHV-7000
- Where
- 150 sites in United States, Australia and 14 more
- Volunteers
- 390 people
- Sponsor
- Biohaven Therapeutics Ltd.
Apathy in Dementia
A Trial of the Safety, Tolerability, and Pharmacodynamics of CVL-871 in Subjects With Dementia-Related Apathy
The purpose of this study is to determine whether CVL-871 is safe and tolerable in patients with Dementia-Related Apathy and if CVL-871 shows changes in clinical measurements of apathy.
- Trial name
- NCT04958031
- Testing
- CVL-871 1.0 mg, CVL-871 3.0 mg
- Where
- 20 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- AbbVie
Dry Eye Syndrome
Safety and Tolerability of Artificial Tears in Dry Eye Subjects
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order.
- Trial name
- NCT00932477
- Testing
- Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear, Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear, Glycerin and Polysorbate 80 based artificial tear
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Allergan
Netherton Syndrome
Evaluation of Topical ATR12-351 in Adults With Netherton Syndrome
The objectives of this clinical trial are to evaluate the safety and tolerability of topically applied ATR12-351, to understand what the body does to ATR12-351, and to observe treatment benefits of the drug in approximately 12…
- Trial name
- NCT06137157
- Testing
- ATR12-351
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Azitra Inc.
Healthy Elderly
A Study In Healthy Elderly People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses Of PF-06743649
The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be…
- Trial name
- NCT02170012
- Testing
- PF-06743649
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Solid Tumor
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
- Trial name
- NCT05438329
- Testing
- DB-1305/BNT325, Pembrolizumab, BNT327
- Where
- 93 sites in United States, China and 1 more
- Volunteers
- 1,123 people
- Sponsor
- DualityBio Inc.
Relapsed or Refractory Haematological Malignancies Including, Acute Myeloid Leukemia
Study to Assess Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed or refractory haematological malignancies.
- Conditions
- Relapsed or Refractory Haematological Malignancies Including, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
- Trial name
- NCT03263637
- Testing
- AZD4573
- Where
- 12 sites in Germany, Netherlands and 1 more
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Clostridium Difficile Associated Disease
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese…
- Trial name
- NCT02725437
- Testing
- Clostridium difficile Vaccine
- Where
- 2 sites in Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Pfizer