Clinical trials: Immune System Disorder (Healthy Volunteer)
Healthy Volunteer, Atopic Dermatitis
A Single and Multiple Ascending Dose Trial of KT-474 in Healthy Adult Volunteers and Patients With Atopic Dermatitis (AD) or Hidradenitis Suppurativa (HS)
KT-474 is an oral heterobifunctional small molecule IRAK4 degrader being developed for the treatment of interleukin-1 receptor (IL-1R)/toll-like receptor (TLR)-driven immune-inflammatory diseases.
- Conditions
- Healthy Volunteer, Atopic Dermatitis, Hidradenitis Suppurativa
- Trial name
- NCT04772885
- Testing
- KT-474
- Where
- 14 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Kymera Therapeutics, Inc.
Systemic Amyloidosis
A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis
This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic…
- Trial name
- NCT05951816
- Testing
- 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m., 99mTc-Pyrophosphate
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Tennessee Graduate School of Medicine
Rheumatoid Arthritis
Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers
HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a member of the Tec family of non-receptor protein tyrosine kinases.
- Trial name
- NCT01765478
- Testing
- HM71224 single ascending dose, HM71224 food effect, HM71224 Multiple ascending dose
- Where
- Netherlands
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Autoimmune Diseases, Sickle Cell Disease
Microvascular and Fibrosis Imaging Study
In this study, Laser Doppler Flowmetry (LDF), Laser Doppler Imaging (LDI), Orthogonal Polarization Spectral Imaging (OPSI), Nail fold video capillaroscopy (NVC) and Optical Coherence Tomography (OCT) will be used to assess…
- Conditions
- Autoimmune Diseases, Sickle Cell Disease, Chronic Graft Versus Host Disease
- Trial name
- NCT01758250
- Testing
- Acoustic Radiation Force Impulse (ARFI), Laser Doppler Flowmetry (LDF), Laser Doppler Perfusion Imaging (LDI)
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Duke University
Asthma
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-labeled epinephrine…
- Trial name
- NCT01255709
- Testing
- Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA, Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Asthma
Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
- Trial name
- NCT02162485
- Testing
- Salmeterol/fluticasone Easyhaler, Salmeterol/fluticasone Easyhaler with charcoal, Seretide Diskus
- Where
- Finland
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Multiple Sclerosis
Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers
Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS).
- Trial name
- NCT01500408
- Testing
- Interferon beta-1a (current approved manufacturing process invloving FBS), Interferon beta-1a (new process, manufactured without FBS)
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Biogen
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Comparison of Sotagliflozin Prototype Tablets With Reference Tablet in Healthy Subjects
Primary Objective: To assess the relative bioavailability of sotagliflozin following single doses of 3 sotagliflozin prototype tablet formulations p1, p2 and p3 versus the reference tablet formulation in fasted conditions in…
- Trial name
- NCT03310944
- Testing
- sotagliflozin (SAR439954)
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04308515 in healthy…
- Trial name
- NCT01101932
- Testing
- PF-04308515, PF-04308515 Tablet
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Pfizer
Relapsing-remitting Multiple Sclerosis (rrMS)
Assess Safety, Bio-distribution, Radiation Dosimetry and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).
To evaluate the safety, bio-distribution, and radiation dosimetry; and to optimize the Imaging Protocol of GEH120714 (18F) Injection.
- Trial name
- NCT01738347
- Testing
- Arm 1 - GEH120714 (18F) Injection
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Rheumatoid Arthritis
A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people.
- Trial name
- NCT02460393
- Testing
- Humanized TNFα monoclonal antibody
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Rheumatoid Arthritis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.
A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD9567.
- Trial name
- NCT02760316
- Testing
- AZD9567 10 mg, AZD9567 20 mg, AZD9567 40 mg
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Relapsed or Refractory Lymphoma
HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study
A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP Enzyme Inducer, on the Pharmacokinetics of…
- Trial name
- NCT05720767
- Testing
- HMPL-523, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Asthma, Atopic Dermatitis
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and…
- Conditions
- Asthma, Atopic Dermatitis, Healthy
- Trial name
- NCT02345928
- Testing
- Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, Part 2 (Atopic Dermatitis): CNTO 7160
- Where
- 7 sites in Belgium, Germany
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Subjects, Rheumatoid Arthritis
Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis
This study evaluates safety, tolerability, biodistribution and performance of the [68Ga]Ga-DOTA-Siglec-9 following a single intravenous administration in patients with active rheumatoid arthritis, vasculitis or pulmonary…
- Conditions
- Healthy Subjects, Rheumatoid Arthritis, Vasculitis, Pulmonary Sarcoidosis
- Trial name
- SIGLEC (NCT03755245)
- Testing
- [68Ga]Ga-DOTA-Siglec-9
- Where
- Finland
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Asthma
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic…
- Trial name
- NCT01194700
- Testing
- Seretide 250(8puffs) via Evohaler actuator
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Brian J Lipworth
Asthma
Mass Balance Recovery, Pharmacokinetics and Metabolite Profile and Identification of [14C]AZD7594
AZD7594 is in clinical development for the treatment of asthma. This is a single centre, open-label, single period study in 6 healthy subjects, to determine the mass balance recovery and generate samples to enable metabolite…
- Trial name
- NCT04002427
- Testing
- Intravenous Infusion, Inhaled dose
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Rheumatoid Arthritis
A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.
- Trial name
- NCT01741493
- Testing
- ABT-494, Tofacitinib
- Where
- 5 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Rheumatoid Arthritis
Investigate the Safety, Tolerability and Pharmacokinetics of FBL-MTX
This is a prospective, single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 study to evaluate the safety, tolerability and pharmacokinetics of FBL-MTX in healthy male and female…
- Trial name
- FolSmart (NCT05117593)
- Testing
- FBL-MTX
- Where
- Portugal
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Kidney Transplant, Myeloma
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons…
- Conditions
- Kidney Transplant, Myeloma, Cancer, Hematologic Malignancy
- Trial name
- EREVA (NCT04952766)
- Testing
- Biological samples
- Where
- France
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Régional d'Orléans
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