Clinical trials: Dose Escalation and Safety
Oculopharyngeal Muscular Dystrophy
Safety Tolerability and Efficacy Study of Cabaletta to Treat Oculopharyngeal Muscular Dystrophy (OPMD) Patients
The Purpose of this study is to assess the Safety, Tolerability and Efficacy of Intravenous Cabaletta® in Oculopharyngeal Muscular Dystrophy (OPMD) Patients.
- Trial name
- HOPEMD (NCT02015481)
- Testing
- Cabaletta
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 25 people
- Sponsor
- Bioblast Pharma Ltd.
Covid19
Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19
This is an interventional, multicenter, 2-arm, parallel-group, randomized, double-blind, placebo controlled, dose-escalation, safety and efficacy study of F-652 treatment versus placebo in patients aged 18 years or older with a…
- Trial name
- NCT04498377
- Testing
- F-652
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- EVIVE Biotechnology
Multiple Myeloma
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
Belantamab mafodotin (GSK2857916) is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation…
- Trial name
- NCT03828292
- Testing
- Belantamab mafodotin, Bortezomib, Dexamethasone
- Where
- 4 sites in Japan
- Volunteers
- 15 people
- Sponsor
- GlaxoSmithKline
Relapsed/Refractory, Multiple Myeloma
A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)
The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone…
- Trial name
- NCT03439280
- Testing
- Mezagitamab, Pomalidomide, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Malaria
Trial to Evaluate L9LS in Healthy Adults
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly.
- Trial name
- VRC 614 (NCT05019729)
- Testing
- VRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Achondroplasia
A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia
The trial is a multicenter, double-blind, randomized, placebo-controlled, dose escalation trial of weekly TransCon CNP administered subcutaneously in prepubertal children 2 to 10 years old, inclusive, with Achondroplasia.
- Trial name
- NCT04085523
- Testing
- TransCon CNP
- Where
- 15 sites in United States, Australia and 6 more
- Volunteers
- 57 people
- Sponsor
- Ascendis Pharma A/S
Hypertension
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension
- Trial name
- NCT00770861
- Testing
- Nebivolol
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 277 people
- Sponsor
- Forest Laboratories
Critical Limb Ischemia
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants.
- Trial name
- NCT03680105
- Testing
- RJX
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Reven Pharmaceuticals, Inc.
Relapsed or Refractory Classical Hodgkin Lymphoma
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).
- Trial name
- NCT05216835
- Testing
- Sabestomig (AZD7789)
- Where
- 14 sites in United States, Canada and 5 more
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Multiple Myeloma
A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Multiple myeloma (MM) is a neoplastic plasma cell disorder that is characterized by osteolytic bone lesions, anemia, hypercalcemia and renal failure.
- Trial name
- NCT04177823
- Testing
- Belantamab mafodotin
- Where
- China
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease
A Study of LY3113593 in Participants With Chronic Kidney Disease
This study is not intended to treat anemia of chronic kidney disease but to determine the safety of the study drug, LY3113593. The study will also evaluate how much of the study drug gets into the blood stream, how long it takes…
- Trial name
- NCT02604160
- Testing
- LY3113593
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Eli Lilly and Company
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and…
- Trial name
- TEXT-TKR (NCT03251482)
- Testing
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, JNJ-64179375 1.2 mg/kg
- Where
- 103 sites in United States, Argentina and 14 more
- Volunteers
- 308 people
- Sponsor
- Janssen Research & Development, LLC
Osteoarthritis, Knee
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I).
- Trial name
- NCT00669409
- Testing
- PF-04383119 (tanezumab)
- Where
- 12 sites in Japan
- Volunteers
- 83 people
- Sponsor
- Pfizer
Advanced Solid Tumors, Advanced Recurrent Ovarian Tumors
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies…
- Trial name
- NCT01248949
- Testing
- MEDI3617, Bevacizumab, Paclitaxel
- Where
- 10 sites in United States
- Volunteers
- 162 people
- Sponsor
- MedImmune LLC
Filariasis
Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside
The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in healthy male caucasian subjects.
- Trial name
- NCT03383614
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Rheumatoid Arthritis
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period.
- Trial name
- NCT01253226
- Testing
- LY2127399 (Tabalumab)
- Where
- 10 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Eli Lilly and Company
Alzheimer's Disease
Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of TB006 in Participants With Alzheimer's Disease
Part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (PK) profile of multiple doses of TB006, as well as the maximum tolerated dose of TB006, and to assess the immunogenicity of TB006…
- Trial name
- NCT05074498
- Testing
- TB006
- Where
- 18 sites in United States
- Volunteers
- 154 people
- Sponsor
- TrueBinding, Inc.
Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or…
- Trial name
- NCT02457793
- Testing
- Cobimetinib, GDC-0994
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Acute Myeloid Leukemia
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia.
- Trial name
- NCT03671564
- Testing
- Milademetan
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
COVID19
Phase I/II Safety, Dose Finding & Antiviral Activity of RD-X19 in Mild/Moderate Outpatient COVID-19
This randomized, Phase I/II feasibility study will evaluate the safety and efficacy of the RD-X19 device in SARS-CoV-2 infected individuals with uncomplicated COVID-19.
- Trial name
- NCT04662671
- Testing
- RD-X19
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- EmitBio Inc.