Clinical trials: Randomized Controlled Trial, Human Study, open to volunteers
- Condition Randomized Controlled Trial, Human Study
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Vulvar Diseases, HPV Infection
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
- Conditions
- Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia
- Trial name
- ART-VIN IIB (NCT06075264)
- Testing
- Artesunate ointment
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Frantz Viral Therapeutics, LLC
Hepatitis E
Study of AT-587 in Healthy Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects
- Trial name
- NCT07728487
- Testing
- AT-587
- Where
- Belgium
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Alzheimer's Disease (AD)
Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's Patients
This study is testing a new investigational drug called 8M2D to learn whether it is safe and well-tolerated in humans. 8M2D has not previously been given to people.
- Trial name
- NCT07568041
- Testing
- 8M2D
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Cenna Biosciences Inc.
Healthy Volunteers
A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants
The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and…
- Trial name
- NCT06682975
- Testing
- ZP9830
- Where
- Netherlands
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Zealand Pharma
Spinal Cord Injury, Safety
Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial
Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord.
- Conditions
- Spinal Cord Injury, Safety, Efficacy, Clinical Trial
- Trial name
- NCT06974968
- Testing
- Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells
- Where
- China
- Volunteers
- 60 people
- Sponsor
- XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Chikungunya, Chikungunya Fever
A Phase I Study of PepGNP-ChikV in Healthy Volunteers
This is a Phase I, randomized, single-blind, placebo-controlled, study of four separate dose cohorts, with a 42-day interval between each vaccine dose, of a novel Chikungunya Peptide Immunotherapy Vaccine in Healthy Adults (18-60…
- Conditions
- Chikungunya, Chikungunya Fever, Chikungunya Virus Infection, Chikungunya Virus Infections
- Trial name
- NCT07394426
- Testing
- PepGNP-ChikV
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Gylden Pharma Ltd
Breast Cancer
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or…
- Trial name
- NCT07003074
- Testing
- TQB2102 for Injection, Docetaxel combined + Trastuzumab +Pertuzumab
- Where
- 25 sites in China
- Volunteers
- 642 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer
A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection…
- Trial name
- NCT07043725
- Testing
- TQB2102 for injection, Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
- Where
- 78 sites in China
- Volunteers
- 544 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Healthy Participants
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
- Trial name
- NCT07035769
- Testing
- Debio 1453P
- Where
- Belgium
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
SARS-CoV-2, Influenza, Human
Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)
The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal…
- Conditions
- SARS-CoV-2, Influenza, Human, Respiratory Syncytial Virus Infections, Respiratory Distress Syndrome
- Trial name
- NCT06684379
- Testing
- PRS CK STORM
- Where
- 3 sites in Spain
- Volunteers
- 50 people
- Sponsor
- PEACHES BIOTECH
Crohn's Disease
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.
- Trial name
- NCT06925594
- Testing
- Human TH-SC01 cell injection, Saline solution
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Not Applicable - Healthy Adult Participants
Study of XmAb412 in Healthy Participants
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
- Trial name
- NCT07713485
- Testing
- XmAb412 Monoclonal Bispecific Antibody
- Where
- 2 sites in Australia
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
Advanced Non-small Cell Lung Cancer, HER2 Mutation
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
- Trial name
- SOHO-02 (NCT06452277)
- Testing
- Sevabertinib, Pembrolizumab, Cisplatin
- Where
- 279 sites in United States, Argentina and 34 more
- Volunteers
- 444 people
- Sponsor
- Bayer
Healthy Volunteer, Atopic Dermatitis
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B).
- Trial name
- AURA-AD (NCT07527923)
- Testing
- REGN20423
- Where
- 7 sites in United States, Belgium
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Influenza
A Trial of RLX-2508-102 in Healthy Volunteers
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose and multiple dose of RLX-2508 in healthy participants across different ethnic backgrounds.
- Trial name
- NCT07873671
- Testing
- RLX-2508
- Where
- 3 sites in Australia
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children
GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
- Conditions
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- Trial name
- NCT07553351
- Testing
- GB06, Norditropin®FlexProTM
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Kexing Biopharm Co., Ltd.
Neisseria Gonorrhea
Safety and Immunogenicity Study of a Multivalent Gonorrhoea Vaccine
The main goal of this trial is to evaluate the safety and immunogenicity of the candidate N. gonorrhoeae vaccine, LTB-NG6.
- Trial name
- LTBNG601 (NCT07758972)
- Testing
- LTB-NG6, Sodium Chloride 0.9%
- Where
- Germany
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Obesity, Overweight
A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight
The primary objective is to evaluate the safety and tolerability of VRB-103 tablets administered as monotherapy or VRB-103 tablets administered in combination with oral ecnoglutide tablets (VRB-101 tablets) in a single-dose…
- Trial name
- NCT07628127
- Testing
- VRB-103, VRB-101
- Where
- 3 sites in Australia
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- Verdiva Bio Dev Limited
Atopic Dermatitis (AD)
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
This Phase 1 study will assess NOR-101, an investigational study drug, in two parts. Part 1 is a randomized, blinded study comparing single and multiple doses of NOR-101 with placebo in healthy adults.
- Trial name
- POLARIS-1 (NCT07904689)
- Testing
- NOR-101
- Where
- Australia
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- North Immunology Inc.