Clinical trials: First in Man Study to Evaluate Initial Safety
- Condition First in Man Study to Evaluate Initial Safety
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Ovarian Cancer, Cervical Cancer
Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors
- Conditions
- Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Non Small Cell Lung Cancer (NSCLC)
- Trial name
- NCT02988817
- Testing
- Enapotamab vedotin (HuMax-AXL-ADC)
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 306 people
- Sponsor
- Genmab
Tumors
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors
The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.
- Trial name
- IMGN853-0401 (NCT01609556)
- Testing
- Mirvetuximab soravtansine
- Where
- 12 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- ImmunoGen, Inc.
Healthy Participants
A Study to Learn About the Study Medicine PF-07853578 and How it Acts in the Bodies of Healthy Adults
The purposes of this study are: To see how the new medicine (PF-07853578) under study is tolerated. And if there are any important side effects. And, how people feel after taking single increasing amount of the medicine by mouth.
- Trial name
- NCT05890105
- Testing
- PF-07853578
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Viral Disease
First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.
It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.
- Trial name
- NCT04535167
- Testing
- PF-07304814
- Where
- 13 sites in United States, Belgium and 2 more
- Volunteers
- 26 people
- Sponsor
- Pfizer
Muscular Dystrophies
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
The FTIH study with GSK3439171A will evaluate the safety of GSK3439171A in healthy subjects in order to avoid confounding factors due to the disease or concomitant drugs in patients.
- Trial name
- NCT03627494
- Testing
- GSK3439171A
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
Renal Cell Carcinoma
Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426)
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell…
- Trial name
- NCT02853331
- Testing
- Pembrolizumab, Axitinib, Sunitinib
- Volunteers
- 861 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Carcinoma, Small Cell
Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma
GSK2879552 is a potent, selective, mechanism-based inactivator of Lysine Specific Demethylase 1 (LSD1)/ CoRepressor for Element-1-Silencing Transcription factor (CoREST) activity.
- Trial name
- NCT02034123
- Testing
- GSK2879552
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 29 people
- Sponsor
- GlaxoSmithKline
Dry Age-related Macular Degeneration, Macular Degeneration
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).
- Conditions
- Dry Age-related Macular Degeneration, Macular Degeneration, Retinal Disease, Eye Diseases
- Trial name
- NCT03846193
- Testing
- GT005, GT005 / Device: Orbit™ Subretinal Delivery System
- Where
- 13 sites in United States, United Kingdom
- Volunteers
- 56 people
- Sponsor
- Gyroscope Therapeutics Limited
Bone Metastases
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
- Trial name
- NCT00981578
- Testing
- ExAblate 2100
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- InSightec
Hepatitis B, Chronic
Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection
A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed participants under nucleo(s)tide treatment.
- Trial name
- NCT03866187
- Testing
- ChAd155-hIi-HBV low dose formulation, ChAd155-hIi-HBV high dose formulation, HBc-HBs/AS01B-4 low dose formulation
- Where
- 43 sites in Belgium, France and 7 more
- Volunteers
- 236 people
- Sponsor
- GlaxoSmithKline
Short Bowel Syndrome, Parenteral Nutrition Associated Liver Disease
Study of NST-6179 in Healthy Subjects
A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.
- Trial name
- NCT05181085
- Testing
- NST 6179
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NorthSea Therapeutics B.V.
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults.
- Trial name
- NCT05163522
- Testing
- VH4004280, Midazolam
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Covid19
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
- Trial name
- NCT04532294
- Testing
- BGB DXP593
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene
Solid Tumor, Adult
A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
The drug that will be investigated in the study is GEN1053. GEN1053 is an antibody designed to (re)activate and increase antitumor immunity.
- Trial name
- NCT05435339
- Testing
- GEN1053
- Where
- 5 sites in United States, Spain
- Volunteers
- 31 people
- Sponsor
- Genmab
Anaemia
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
This study is intended to evaluate the dose-response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks to maintain hemoglobin (Hgb) level in…
- Trial name
- NCT01977482
- Testing
- GSK1278863, rhEPO
- Where
- 107 sites in United States, Australia and 14 more
- Volunteers
- 216 people
- Sponsor
- GlaxoSmithKline
Autism Spectrum Disorder
Safety, Tolerability and Pharmacokinetics Study of STP1 in a Subgroup of Patients With Autism Spectrum Disorder (ASD)
The main purpose of this study is to evaluate safety and tolerability in a subgroup of patients with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04644003
- Testing
- STP1
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stalicla SA
Influenza Prevention
A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults
The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to…
- Trial name
- NCT05901636
- Testing
- INFLUENZA G1 mHA, Al(OH)3
- Where
- 4 sites in United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.