Clinical trials: First in Man Study to Evaluate Initial Safety
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
A Study of EDP-297 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Trial name
- NCT04559126
- Testing
- EDP-297
- Where
- Netherlands
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Infection, Bacterial
A First-in-Human Study With XAB05 in Healthy Subjects
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
- Trial name
- NCT05307406
- Testing
- Experimental
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Xenothera SAS
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy…
- Trial name
- NCT01596335
- Testing
- TA-650, Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
- Where
- 8 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Tanabe Pharma Corporation
Stargardt Disease 1, STGD1
A Phase 1, First-in-Human Study of CITY-RBP4 in Healthy Volunteers and STGD1 Participants
This is a first-in-human (FIH), multicenter, randomized, double-masked, placebo-controlled adaptive clinical study evaluating the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of CITY-RBP4, following…
- Conditions
- Stargardt Disease 1, STGD1, Healthy Volunteers
- Trial name
- NCT07836452
- Testing
- CITY-RBP4
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- City Therapeutics
Osteogenesis Imperfecta
A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
- Trial name
- NCT06086613
- Testing
- AGA2115
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Angitia Incorporated Limited
Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS)
A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma
SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B.
- Conditions
- Osteosarcoma Metastatic, Soft Tissue Sarcoma (STS), Osteosarcoma, Advanced
- Trial name
- NCT07801222
- Testing
- SOT106
- Where
- Moldova
- Volunteers
- 70 people
- Sponsor
- SOTIO Biotech a.s.
Vascular Closure Device, Femoral Arteriotomy Closure
Initial Safety and Preliminary Efficacy of the Novelrad Vascular Closure System (NVCS)
This study evaluates the initial safety and preliminary efficacy of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing…
- Conditions
- Vascular Closure Device, Femoral Arteriotomy Closure, Femoral Access Site Closure
- Trial name
- NCT07858903
- Testing
- Novelrad Vascular Closure System (NVCS)
- Where
- 3 sites in Israel
- Volunteers
- 15 people
- Sponsor
- Novelrad Ltd.
Advanced Solid Tumors
A First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors
Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are types of cancer that may have spread to nearby tissue, lymph nodes, and/or to distant parts of the body and that…
- Trial name
- NCT05614102
- Testing
- BAY2965501, Pembrolizumab, Platinum-based Chemotherapy
- Where
- 21 sites in United States, Belgium and 5 more
- Volunteers
- 284 people
- Sponsor
- Bayer
Diabetes Mellitus, Type 2
RF Vapor Ablation Retreatment of Duodenal Mucosa in Non-responders With Type-2 Diabetes Mellitus
The purpose of this study is to test the hypothesis that re-treatment of the duodenal mucosa with RF vapor ablation will result in improvement in glycemic parameters, without complications (bleeding/ stricture / perforation)…
- Trial name
- NCT06724822
- Testing
- RF Vapor Ablation
- Where
- Chile
- Volunteers
- 12 people
- Sponsor
- Aqua Medical, Inc.
Healthy Volunteers, Rheumatoid Arthritis
A Study of Intravenous CPTX2309 in Healthy Participants and Participants With Moderate to Severe Rheumatoid Arthritis (RA) or Systemic Lupus Erythematosus (SLE)
The purpose of this study is to assess the safety and tolerability of CPTX2309 in healthy adult participants and adult participants with moderate to severe rheumatoid arthritis or systemic lupus erythematosus.
- Conditions
- Healthy Volunteers, Rheumatoid Arthritis, Systemic Lupus Erythematosus
- Trial name
- NCT06917742
- Testing
- CPTX2309
- Where
- 3 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Capstan Therapeutics
Healthy Participants Study
First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants
This is a first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants.
- Trial name
- NCT06673667
- Testing
- KT-621
- Where
- 2 sites in United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Kymera Therapeutics, Inc.
Healthy
A Study of LY3305677 in Healthy Participants
The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it. This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to…
- Trial name
- NCT02972645
- Testing
- LY3305677
- Where
- United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Migraine
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants
This first in-human (FIH) study of UB-313, an anti-calcitonin gene-related peptide based immunotherapeutic candidate, is designed to assess the safety, tolerability, and immunogenicity of 4 selected UB-313 dose regimens in…
- Trial name
- NCT05477095
- Testing
- UB-313
- Where
- Belgium
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Vaxxinity, Inc.
Chronic Hepatitis B Virus Infection
A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B
This study will examine the safety and tolerability of single and multiple doses of IB-001 in two parts: Part A: SAD study in approximately 50 Healthy Volunteers (HV).
- Trial name
- NCT07389044
- Testing
- IB-001, Peginterferon Alfa-2A
- Where
- 5 sites in Hong Kong, Moldova and 2 more
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- IntegerBio
Hearing Loss, Sensorineural
First in Human Safety Study of FX-345 in Adults With Sensorineural Hearing Loss
This single-blind, placebo-controlled trial will be conducted to evaluate the safety of FX-345 administered as a single intratympanic injection in adults with acquired sensorineural hearing loss.
- Trial name
- NCT05664100
- Testing
- FX-345
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Frequency Therapeutics
Locally Advanced or Metastatic Solid Tumours
A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer
This open labelled first in human dose phase 1/2a study is designed to evaluate safety, feasibility and efficacy of multiple dosing with individualised VB10.NEO and bempegaldesleukin (NKTR-214) immunotherapy in patients with…
- Trial name
- DIRECT-01 (NCT03548467)
- Testing
- VB10.NEO, Bempegaldesleukin
- Where
- 6 sites in Germany
- Volunteers
- 41 people
- Sponsor
- Nykode Therapeutics ASA
Cognitive Disorders
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.
- Trial name
- NCT02575482
- Testing
- SUVN-D4010
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Suven Life Sciences Limited
Anti-MAG Neuropathy
First in Human Study to Test the Safety and Preliminary Efficacy of PPSGG in Patients With Anti-MAG Neuropathy
In this study, the new drug called PPSGG (PN-1007) will be tested. Preliminary studies conducted in animals suggest PPSGG (PN-1007) might be a good treatment for reducing levels of anti-MAG antibodies in patients with anti-MAG…
- Trial name
- NCT04568174
- Testing
- PPSGG
- Where
- 7 sites in France, Netherlands and 3 more
- Volunteers
- 1 people
- Sponsor
- Polyneuron Pharmaceuticals AG
Femoropopliteal In-Stent Restenosis
First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
- Trial name
- NCT01962389
- Testing
- Winsor Laser Catheter
- Where
- Colombia
- Sponsor
- Spectranetics Corporation