Clinical trials: Phase I
Healthy Volunteers and Asthma
A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16
The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose)…
- Trial name
- NCT01704040
- Testing
- CNTO 3157 (healthy participants), CNTO 3157 (asthmatic patients), HRV-16
- Where
- 13 sites in Belgium, Canada and 4 more
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment
To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.
- Trial name
- NCT02873650
- Testing
- dabrafenib
- Where
- 4 sites in United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Dyslipidemias
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.
- Conditions
- Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders
- Trial name
- NCT01435382
- Testing
- PF-04950615 (RN316)
- Where
- 7 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Advanced Malignant Solid Tumors
A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-295S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
- Trial name
- NCT04908046
- Testing
- HMPL-295S1 with dose escalation stage of 5mg up to 200mg, then expansion stage with recommended dose of therapeutic cycle of 28 days .
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Hutchmed
Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL
Phase I clinical study of multicenter, single-arm, open, non-randomized evaluation of recombinant humanized anti-CD52 monoclonal antibody in the NHL and T-PLL
- Trial name
- NCT05557903
- Testing
- Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection
- Where
- China
- Volunteers
- 71 people
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
B-cell Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma…
- Conditions
- B-cell Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma
- Trial name
- NCT04594642
- Testing
- AZD0486 IV
- Where
- 25 sites in United States, Australia and 3 more
- Volunteers
- 226 people
- Sponsor
- AstraZeneca
Healthy
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.
- Trial name
- NCT01454986
- Testing
- ALXN1007
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
IL-2 Induced Hypotension
Evaluation of M40403 for the Prevention of Dose Limiting Toxicities of High Dose IL-2
The clinical use of IL-2 is currently limited by development of dose-dependent hypotension (systolic blood pressure (SBP) < 90 mm Hg).
- Trial name
- NCT00033956
- Testing
- M40403
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- MetaPhore Pharmaceuticals
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy…
- Trial name
- NCT04036227
- Testing
- GS-248
- Where
- Sweden
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
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
Non-Hodgkin's Lymphoma
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199
This is an open-label multicenter, study to assess the pharmacokinetic interaction of ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.
- Trial name
- NCT01969669
- Testing
- ABT-199, Ketoconazole
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- AbbVie
Locally Advanced or Metastatic Solid Tumor
AZD5305 hADME in Patients With Advanced Solid Malignancies
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of [14C]-Saruparib in patients with advanced solid malignancies.
- Trial name
- AZD5305 (NCT06713369)
- Testing
- Saruparib (AZD5305), [14C]-AZD5305 microtracer, [14C]-AZD5305 (therapeutic dose)
- Where
- 2 sites in United Kingdom
- Volunteers
- 8 people
- Sponsor
- AstraZeneca
Healthy Volunteers
Lung Deposition Via Different Inhalation Devices
The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.
- Trial name
- NCT00975754
- Testing
- Pulmicort pMDI HFA, Budesonide pMDI HFA, Pulmicort Repulses
- Where
- Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting…
- Trial name
- NCT07610005
- Testing
- Varegacestat Reference Formulation, Varegacestat Test Formulation A, Varegacestat Test Formulation B
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Healthy Participants
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies…
- Trial name
- NCT05720494
- Testing
- JZP441
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Non Small Cell Lung Cancer
A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis
This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small cell lung cancer (NSCLC) with small…
- Trial name
- NCT05180422
- Testing
- AMG 510, MVASI
- Where
- United States
- Sponsor
- Criterium, Inc.
Sanfilippo Syndrome B
Intracerebral Gene Therapy in Children With Sanfilippo Type B Syndrome
This is an open-label, phase I/II study of intra-cerebral administration of adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from Sanfilippo type B syndrome.
- Trial name
- NCT03300453
- Testing
- rAAV2/5-hNAGLU
- Where
- France
- Volunteers
- 4 people
- Sponsor
- UniQure Biopharma B.V.
B-cell Mediated Autoimmune Disorders
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
- Trial name
- NCT06680037
- Testing
- Azercabtagene zapreleucel (azer-cel)
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- TG Therapeutics, Inc.
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