Clinical trials: Phase 1b
Healthy
A Study To Examine Safety, Pharmacokinetics, And Pharmacodynamic Of Pf 06412562 In Healthy Males
This study is designed to investigate the safety, tolerability pharmacokinetics and pharmacodynamic effects of PF-06412562 following multiple dose administration as MR tablets in healthy adult males.
- Trial name
- NCT02306876
- Testing
- PF-06412562 3mg BID, PF-06412562 15mg BID
- Where
- 3 sites in United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived…
- Trial name
- NCT03522506
- Testing
- TAK-925, Modafinil
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Pain
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram.
- Trial name
- NCT03312777
- Testing
- Omnitram, Tramadol
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syntrix Biosystems, Inc.
Pulmonary Arterial Hypertension
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial…
- Trial name
- AIR001-CS02 (NCT00814645)
- Testing
- Sodium Nitrite Inhalation Solution
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aires Pharmaceuticals, Inc.
Healthy
Study Investigating the Pharmacokinetic Interaction Between INX-08189 and Verapamil HCL ER in Healthy Volunteers
The purpose of this study is to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between INX-08189 and extended release verapamil hydrochloride (verapamil HCL ER).
- Trial name
- INX-189-005 (NCT01471704)
- Testing
- INX-08189 50 mg, 240 mg verapamil HCL ER, 50 mg dose of INX-08189 and 240 mg verapamil HCL ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in…
- Conditions
- Allergic Rhinitis, Allergic Rhinitis Due to Grass Pollen, Healthy Volunteers
- Trial name
- NCT03290248
- Testing
- B244 suspension, Vehicle
- Where
- 2 sites in United States, Canada
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AOBiome LLC
NASH - Nonalcoholic Steatohepatitis, Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X…
- Trial name
- NCT03976687
- Testing
- EYP001a
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Influenza A
Safety and Immunogenicity of the Bris10 M2SR and Sing2016 M2SR H3N2 Monovalent Influenza Vaccines
This is a Phase I double-blind, randomized, placebo-controlled study in 250 healthy adults, 18-49 years of age, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03999554
- Testing
- LD Sing2016 M2SR H3N2 influenza vaccine, MD Sing2016 M2SR H3N2 influenza vaccine, HD Sing2016 M2SR H3N2 influenza vaccine
- Where
- 4 sites in United States
- Volunteers
- 206 people, healthy volunteers welcome
- Sponsor
- FluGen Inc
Alcohol Use Disorder
Phase 1b Study of DCR-AUD in Healthy Volunteers
The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers.
- Trial name
- NCT05845398
- Testing
- DCR-AUD
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Elevated Blood Pressure, Hypertension
HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood…
- Trial name
- NCT07644364
- Testing
- HJB647
- Where
- Japan
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects (Phase 1) and of two doses in Adults with Cystic Fibrosis (Phase 1b).
- Trial name
- NCT05712538
- Testing
- ARCT-032
- Where
- New Zealand
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Arcturus Therapeutics, Inc.
Aging
aKLmRNA-mediated Protein Replacement Therapy
This is a Phase 1b randomized, double-blind, placebo-controlled study to assess the safety and tolerability of a proprietary aKLmRNA formulated in lipid nanoparticles. Approximately 21 subjects will be enrolled.
- Trial name
- NCT07544420
- Testing
- aKLmRNA (AKL003)
- Where
- Honduras
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Klothea Bio Inc
Influenza
Influenza Vaccine Challenge Study in Healthy Subjects
The purpose of this research is to study the safety, tolerability and effectiveness of the investigational influenza vaccine in healthy volunteers infected with an attenuated influenza A virus.
- Trial name
- NCT01226758
- Testing
- Influenza vaccine (FLU-v)
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- PepTcell Limited
Pneumococcal Infections
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
- Trial name
- NCT03642847
- Testing
- Prevnar 13, multivalent pneumococcal conjugate formulation 1, multivalent pneumococcal conjugate formulation 2
- Where
- 4 sites in United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of GEn1E-1124
In this early phase clinical research study, the investigational drug will be administered to 64 healthy volunteers in a double-blind, placebo-controlled manner, at a one research center.
- Trial name
- NCT04728061
- Testing
- Gen1E-1124
- Where
- New Zealand
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GEn1E Lifesciences
Knee Osteoarthritis
Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)
Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the…
- Trial name
- NCT06463132
- Testing
- PEP/Euflexxa, PEP
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rion Inc.
Healthy Volunteers
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
- Trial name
- NCT02419001
- Testing
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB
- Where
- 3 sites in United States, Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Healthy Volunteers
Evaluation of Oral PF614 Relative to OxyContin (PF614-102)
This is a single-center study incorporating 2 parts: A Multiple Ascending Dose Study (Part A) and a comparative Bioavailability/Bioequivalence and Food Effect study (Part B).
- Trial name
- NCT05043766
- Testing
- PF614, Naltrexone Hydrochloride, OxyContin
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Ensysce Biosciences
Facial Fine Lines
Intradermal (ID) BOTOX in the Treatment of Facial Fine Lines
The main objective of this study is to assess safety and tolerability of Intradermal (ID) BOTOX in participants with facial fine lines.
- Trial name
- NCT04631588
- Testing
- Botox
- Where
- 5 sites in United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Allergan