Clinical trials: Dose Escalation and Safety
Healthy
First-in-Human Single and Multiple Dose of GLPG1972
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo.
- Trial name
- NCT02612246
- Testing
- GLPG1972 single ascending doses, GLPG1972 multiple ascending doses
- Where
- Belgium
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Healthy
A Single Ascending Dose Escalation to Investigate Safety and PK of VVZ-149 Injection in Healthy Older Male Volunteers
The objective of this study is to investigate the safety, tolerability and pharmacokinetics (PK) of VVZ-149 injection after a single dose or loading/maintenance dose in healthy older male volunteers.
- Trial name
- NCT02333318
- Testing
- VVZ-149 injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vivozon, Inc.
Solid Tumors
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.
- Trial name
- NCT00882180
- Testing
- ALN-VSP02
- Where
- 10 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy Volunteers
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
This is randomized, double-blind, placebo-controlled, multiple ascending dose study of Q203 in healthy volunteers conducted at one study center in the United States
- Trial name
- NCT02858973
- Testing
- Q203
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Qurient Co., Ltd.
Allogeneic, CAR-T, Protein Sequestration, Non-gene Edited, r/r B-NHL
Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Refractory or Relapsed B Cell Lymphoma
This is a single dose escalation study to evaluate the safety, efficacy and pharmacokinetics of ThisCART19A (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell Lymphoma.
- Trial name
- NCT05535673
- Testing
- ThisCART19A
- Volunteers
- 15 people
- Sponsor
- Zhengzhou University
Renal Insufficiency, Chronic, Kidney Disease, Chronic
A Study of LY2928057 in Hemodialysis Participants
This study will evaluate the safety of LY2928057 and how LY2928057 affects hemoglobin in hemodialysis participants. This study will involve multiple doses of LY2928057 given during a 6 week period either after a participant…
- Trial name
- NCT01991483
- Testing
- LY2928057
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
Kidney Diseases
YSPSL for Prevention of Delayed Graft Function Part B
Selectins have been implicated in the pathogenesis of ischemia/reperfusion (I/R)-induced kidney injury and resultant delayed graft function (DGF). PSGL-1 is a ligand for P-, E-, and L-selectin.
- Trial name
- NCT00298168
- Testing
- YSPSL
- Where
- 15 sites in United States
- Volunteers
- 60 people
- Sponsor
- Y's Therapeutics, Inc.
Refractory or Recurrent CD30+ Hematologic Malignancies
A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with…
- Trial name
- NCT03894150
- Testing
- F0002-ADC
- Where
- 2 sites in China
- Volunteers
- 45 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Spasticity
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total…
- Trial name
- LANTIMA (NCT04752774)
- Testing
- Corabotase, Dysport
- Where
- 81 sites in United States, Austria and 12 more
- Volunteers
- 240 people
- Sponsor
- Ipsen
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Trial name
- NCT06745297
- Testing
- BI 3776528, short-acting benzodiazepine
- Where
- Germany
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Ebola Virus
Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)
This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001.
- Trial name
- NCT02269423
- Testing
- V920
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Systolic Heart Failure
Study of Dapansutrile Capsules in Heart Failure
This is a Phase 1b randomized, double-blinded, single-center safety and pharmacodynamics study of sequential cohort, dose-escalating, repeat-dosing of dapansutrile or placebo (4:1 ratio) in subjects with stable systolic heart…
- Trial name
- NCT03534297
- Testing
- dapansutrile capsules
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Olatec Therapeutics, Inc.
Alcoholic Hepatitis
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe…
- Trial name
- AH (NCT03432260)
- Testing
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Durect
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Solid Tumors and Non-Hodgkin's Lymphoma
A Phase Ib Study of the Safety, Tolerability and Efficacy of LY2780301 in Combination With Gemcitabine
In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6.
- Trial name
- INPAKT (NCT02018874)
- Testing
- LY2780301, Gemcitabine
- Where
- France
- Volunteers
- 52 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Refractory Partial Seizures
To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Trial name
- NCT00699582
- Testing
- E2007 (perampanel)
- Where
- 92 sites in United States, Austria and 12 more
- Volunteers
- 389 people
- Sponsor
- Eisai Inc.
Gastrointestinal Tumors, Colorectal Adenocarcinomas
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
- Conditions
- Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
- Trial name
- NCT04171141
- Testing
- PF-07062119, Anti-PD1, Anti-VEGF
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 79 people
- Sponsor
- Pfizer
Healthy
Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.
- Trial name
- NCT01343719
- Testing
- BI 661051
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 1 Diabetes, Type 1 Diabetes (T1D)
Study of IMC-S118AI in Type 1 Diabetes
This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens.
- Conditions
- Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1
- Trial name
- NCT07493122
- Testing
- IMC-S118AI
- Volunteers
- 154 people
- Sponsor
- Immunocore Ltd
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)
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.