Clinical trials: Phase 1
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
- Trial name
- NCT04091061
- Testing
- PF-06865571 100 mg
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study of NAV-240 in Healthy Volunteers
The primary purpose of this study is to evaluate the safety and tolerability of intravenous (IV) doses of NAV-240 in healthy volunteers.
- Trial name
- NCT06181786
- Testing
- NAV-240
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Navigator Medicines, Inc.
Healthy Participants
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered subcutaneously as a single dose, in healthy Chinese and Japanese study…
- Trial name
- NCT06716879
- Testing
- Donzakimig
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Cystic Fibrosis
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein.
- Trial name
- NCT00970346
- Testing
- OligoG CF-5/20
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- AlgiPharma AS
Healthy
A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects
This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.
- Trial name
- NCT01548391
- Testing
- HX-1171
- Where
- South Korea
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Biotoxtech Co., Ltd
Intestinal Disorder, Bowel Diseases, Inflammatory
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
- Trial name
- NCT04587713
- Testing
- TD-1473 [Tablet A], TD-1473 [Tablet B]
- Where
- 2 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Healthy
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF 04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
- Trial name
- NCT02341482
- Testing
- PF-04958242, Itraconazole
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Biogen
SARS-CoV-2 Infection
Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine
This study aims to address evidence gaps regarding the safety, reactogenicity and immune responses of a heterologous boost of a single dose of Ad26.COV2.S (half or full dose) at pre-specified time intervals in recipients who are…
- Trial name
- NCT05109559
- Testing
- Full dose of Ad26.COV2. 5x10^10vp, Half dose of Ad26.COV2. 2.5x10^10vp
- Where
- Thailand
- Volunteers
- 690 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Type 2 Diabetes Mellitus
Safety Study of ISIS 325568 in Healthy Volunteers
The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.
- Trial name
- NCT00519727
- Testing
- ISIS 325568
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
HIV/AIDS
Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults
The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.
- Trial name
- NCT02346084
- Testing
- Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Malaria
Safety of and Immune Response to a Malaria Vaccine (MSP1 42-C1) With or Without CPG 7909 Adjuvant
The purpose of this study is to determine the safety of and immune response to a preventive malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults.
- Trial name
- NCT00320658
- Testing
- MSP1 42-C1/Alhydrogel, CPG 7909
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Viral; Infection, Coxsackie(Virus)
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.
- Trial name
- PROVENT (NCT04690426)
- Testing
- PRV-101
- Where
- Finland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Provention Bio, Inc.
Polio
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants.
- Trial name
- NCT04264598
- Testing
- sIPV, Commercialized sIPV, Commercialized IPV
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Healthy, Japanese
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects.
- Conditions
- Healthy, Japanese, Non-Asian
- Trial name
- NCT03250598
- Testing
- AG-348
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
HIV Infections
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
This study will test the immune system response to and safety of two HIV vaccines alone and in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus with man-made parts of HIV attached to it.
- Trial name
- NCT00076063
- Testing
- ALVAC-HIV (vCP1452), LIPO-5
- Where
- 11 sites in United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pharmacokinetic Assessments in Healthy Volunteers
Phase 1 Study of Relative Bioavailability of PPI-668 New Tablet Versus Capsule Formulations
This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet, T003.
- Trial name
- NCT02258321
- Testing
- PPI-668 tablet, PPI-668 capsule
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Presidio Pharmaceuticals, Inc.
Mass Balance Recovery
Study in Healthy Adult Female Subjects
An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] D-0502 Following Single Oral Dose Administration
- Trial name
- NCT05339633
- Testing
- [14C]-D-0502
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Healthy Volunteers
To Evaluate the Safety and the Pharmacokinetics of NVP-2203
The purpose of this study is to evaluate the safety and pharmacokinetics after administration of NVP-2203.
- Trial name
- NCT05725252
- Testing
- NVP-2203, NVP-2203-R
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- NVP Healthcare
Healthy
A Study of SPY001-001 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose, first in human safety, tolerability, and pharmacokinetic study of SPY001-001 in healthy participants.
- Trial name
- NCT06448247
- Testing
- SPY001-001
- Where
- 2 sites in United States, Canada
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Spyre Therapeutics, Inc.
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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