Clinical trials: Immunogenicity, open to volunteers
Healthy
Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Ascending Doses BCD-261 in Healthy Subjects
The goal of this clinical trial is to investigate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-261 after single subcutaneous injection at ascending doses and proposed therapeutic doses…
- Trial name
- NCT06715540
- Testing
- BCD-261, dose 1, BCD-261, dose 2, BCD-261, dose 3
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biocad
Beta-Thalassemia
A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and…
- Trial name
- NCT06772766
- Testing
- 9MW3011
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months.
- Trial name
- NCT07793175
- Testing
- EV71 vaccine
- Where
- Vietnam
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Solid Tumor, Lymphoma
A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma（Keyplus-001）
This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.
- Trial name
- NCT05357651
- Testing
- LB1410
- Where
- China
- Volunteers
- 100 people
- Sponsor
- L & L Bio Co., Ltd., Ningbo, China
Skin Disease, Immune System Disease
A Study of HL40626S Tablets in Healthy Adults
This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and…
- Conditions
- Skin Disease, Immune System Disease, Skin Diseases, Papulosquamous, Psoriasis (PsO)
- Trial name
- NCT07736586
- Testing
- HL40626S tablets
- Where
- 2 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- HighsLab Therapeutics Inc.
Advanced Solid Tumor
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
- Trial name
- NCT07811037
- Testing
- SGT003
- Where
- China
- Volunteers
- 332 people
- Sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
Respiratory Syncytial Virus Infections
A Study of BLB-201 RSV Vaccine in Infants and Children
This Phase 1/2a trial is a randomized, placebo-controlled trial to evaluate the safety, tolerability and immunogenicity of two ascending doses (10^6 PFU and 10^7 PFU) of intranasal BLB-201 (a recombinant parainfluenza virus type…
- Trial name
- NCT05655182
- Testing
- PIV5-vectored RSV Vaccine (BLB-201) Low Dose, PIV5-vectored RSV Vaccine (BLB-201) High Dose
- Where
- 18 sites in United States
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Blue Lake Biotechnology Inc.
Healthy Volunteers - Male and Female
A Phase I Trial of Subcutaneous QLS7305 in Healthy Adults
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China.
- Trial name
- NCT07313150
- Testing
- QLS7305 Injection
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Varicella (Chickenpox), Varicella Immunisation
Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children
This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled.
- Trial name
- NCT07473427
- Testing
- Varicella Vaccine
- Where
- Vietnam
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
Ovarian Cancer, Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer
- Trial name
- NCT06366490
- Testing
- Innocell Autologous Cellular Immunotherapy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- PhotonPharma, Inc.
Advanced Malignancies
A Phase 1 Study of HCB303 in Participants With Advanced Malignancies
A Phase 1, Open-label, Multi-regional, Multicenter, Dose escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants with…
- Trial name
- NCT07859228
- Testing
- HCB303
- Volunteers
- 150 people
- Sponsor
- FBD Biologics Limited
Systemic Lupus Erythematosus (SLE)
Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells
This study will investigate the safety and efficacy of allogeneic umbilical cord-derived stem cell therapy in treating patients with moderate to severe systemic lupus erythematosus.
- Trial name
- NCT07041801
- Testing
- hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose), hUC-MSCs treatment (high dose)
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
Assisted Reproductive Technology, Female Infertility
A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects.
- Trial name
- NCT06599528
- Testing
- T-R (Test-Reference drug), R-T (Reference-Test drug)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Suzhou Centergene Pharmaceuticals Co.,Ltd.
Rheumatoid Arthritis, Systemic Lupus Erythematosus
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07649265
- Testing
- HBM7020
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
A Study of V132 in Healthy Older Participants (V132-001)
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
- Trial name
- NCT07712575
- Testing
- V132 Formulation 1, V132 Formulation 2, V132 Formulation 3
- Where
- 10 sites in United States
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Varicella (Chickenpox), Varicella Immunisation
Second Dose of Varicella Vaccine in Healthy Children
This study aim to assess the immunogenicity and safety of interchangeable administration of the second dose of varicella vaccine. A total of 300 healthy participants aged 15 months - 12 years will be enrolled.
- Trial name
- NCT07475000
- Testing
- PROVARIX
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
Respiratory Syncytial Virus, Human Metapneumovirus
Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy…
- Conditions
- Respiratory Syncytial Virus, Human Metapneumovirus, Healthy Volunteers
- Trial name
- NCT07810010
- Testing
- Bivalent RSV+HMPV protein vaccine
- Where
- 21 sites in Australia, United Kingdom
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Sanofi
Health Adult Subjects, Moderate-to-Severe Atopic Dermatitis
A Phase I Study of HXN5003 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN5003 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT07801612
- Testing
- HXN5003
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
Pneumococcal Immunization, Healthy Volunteers
Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies"…
- Trial name
- NCT07348692
- Testing
- PCV21 vaccine, 20vPCV licensed vaccine
- Where
- 25 sites in United States, Honduras and 2 more
- Volunteers
- 2,195 people, healthy volunteers welcome
- Sponsor
- Sanofi
Overweight , Obesity
Study of UBT37034 Injection
This is a study of UBT37034 for injection in participants who have obesity or are overweight. The main purpose is to learn more about the safety, tolerability, drug concentration, drug action and immune response of repeated…
- Trial name
- NCT07873645
- Testing
- UBT37034
- Where
- China
- Volunteers
- 40 people
- Sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.