Clinical trials: Phase I
Healthy
A Phase 1/2A Study to Evaluate the Safety, Immunogenicity, and Shedding of MEDI-560 in Infants 1 to < 12 Months of Age
The primary objective of this study is to describe the safety and tolerability of 3 doses of MEDI-560 at 10^5 TCID50 when administered to children 6 to < 12 months of age who are HPIV3 (human parainfluenza virus type 3)…
- Trial name
- NCT00508651
- Testing
- MEDI-560
- Where
- 23 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Healthy Male Subjects
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-KW-6356
This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356.
- Trial name
- NCT04147910
- Testing
- KW-6356
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin, Inc.
Bacterial Infection, Multiple-drug Resistance
Intravenous Fosfomycin Pharmacokinetics Study
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window).
- Conditions
- Bacterial Infection, Multiple-drug Resistance, Pathogen Resistance
- Trial name
- NCT03910673
- Testing
- Fosfomycin disodium
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon®
- Trial name
- NCT02175394
- Testing
- Microgynon®, BI 1356
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Mild Cognitive Impairment (MCI), Cognition
LpD3.5 Intervention Study in Older Adults- LISA-I Trial
This randomized placebo-controlled clinical study, called the LpD3.5 Intervention Study in Older Adults (LISA), aims to evaluate whether a heat-inactivated postbiotic of human origin (LpD3.5) can serve as a non-pharmacological…
- Conditions
- Mild Cognitive Impairment (MCI), Cognition, Brain Aging, Microbiome Dysbiosis
- Trial name
- Postbiotics (NCT07794956)
- Testing
- LpD3.5
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of South Florida
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
Influenza
Reverse Genetic H9N2 Influenza Vaccine Study in Adults
The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.
- Trial name
- NCT01320696
- Testing
- Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine
- Where
- 5 sites in United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
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
Coronavirus
Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine
In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups.
- Trial name
- NCT04445194
- Testing
- Recombinant new coronavirus vaccine (CHO cell) low-dose group, Recombinant new coronavirus vaccine (CHO cells) high-dose group
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Respiratory Syncytial Virus Infections
Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the…
- Trial name
- NCT07582796
- Testing
- Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant), Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant)
- Where
- China
- Volunteers
- 470 people, healthy volunteers welcome
- Sponsor
- Ab&B Bio-tech Co., Ltd.JS
HIV Infections, HIV Seronegativity
Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults
The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine.
- Trial name
- NCT00027261
- Testing
- ALVAC(2)120(B,MN)GNP (vCP1452)
- Where
- 13 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Abnormally Healing Wounds, Scars
Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction
A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing stromal vascular fraction (SVF) obtained from…
- Conditions
- Abnormally Healing Wounds, Scars, Soft Tissue Defects
- Trial name
- NCT02590042
- Testing
- ADSC-SVF-002
- Where
- Canada
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- AdiSave Inc.
Health Adult Subjects
A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to…
- Trial name
- NCT07199270
- Testing
- GR2303 injection
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Gout, Hyperuricemia
Safety and Efficacy Study of Intravenous Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.
- Trial name
- NCT01021241
- Testing
- Uricase-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- EnzymeRx
Obesity
A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Participants
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.
- Trial name
- NCT07716241
- Testing
- HS-20136-2
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hematologic Neoplasms
Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high.
- Trial name
- NCT05327023
- Testing
- donor lymphocyte infusion, Cyclophosphamide, Busulfan
- Where
- United States
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Healthy
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
This study aims to investigate the effect of multiple doses of BI 1358894 on pharmacokinetics of ethinylestradiol (EE) and drospirenone (DRSP) (Yasmin®)
- Trial name
- NCT05934942
- Testing
- Yasmin®, BI 1358894
- Where
- Germany
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Drug-Drug Interaction (DDI) Study for TQB3616
To evaluate the effect of itraconazole/rifampicin on the pharmacokinetics of TQB3616 capsules. To assess the safety of a single dose of oral TQB3616 capsules and in combination with itraconazole/rifampicin.
- Trial name
- NCT06662773
- Testing
- TQB3616 capsule + itraconazole, TQB3616 capsule + rifampicin
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Vulvar Atrophy
Study of Intravaginal Tamoxifen in PostMenopausal Women With VVA
The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.
- Trial name
- DARE-VVA1 (NCT05378269)
- Testing
- Tamoxifen
- Where
- 2 sites in Australia
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Seasonal Influenza
Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.
- Trial name
- NCT03859141
- Testing
- Quadrivalent influenza vaccine, Trivalent influenza vaccine (contains B/Victoria strain), Trivalent influenza vaccine (contains B/Yamagata strain)
- Where
- 2 sites in China
- Volunteers
- 2,340 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
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