Phase 1 Healthy Volunteer Study
Listing Websites about Phase 1 Healthy Volunteer Study
Healthy volunteers in first-in-human oncology drug …
(1 days ago) Web1 BACKGROUND. First-in-human (FIH) phase 1 clinical studies have traditionally been conducted in healthy volunteers (HVs) …
https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15092
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Healthy volunteers in US phase I clinical trials: …
(3 days ago) WebIntroduction. People from disadvantaged sociodemographic groups, especially people of color, are more likely to participate as healthy volunteers in US Phase I clinical trials that test drug toxicity levels and side effects [1–3].Conversely, the same sociodemographic groups who serve as healthy volunteers in these safety trials are …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423261/
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Reviewing the role of healthy volunteer studies in drug …
(3 days ago) WebClinical drug development is divided into 4 phases. Phase 1 studies are designed to establish the safety and tolerability profile of an investigational drug and the recommended Phase 2 dose [ 1 – 3 ]. Phase 2 studies are designed to establish the clinical effectiveness of a novel drug candidate in a small patient population at a therapeutic
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6278009/
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Design and Conduct Considerations for First‐in‐Human …
(3 days ago) WebAttribution of an AE to an experimental therapy when many events occur spontaneously in the study population is problematic and the dimensions of the problem are magnified in studies conducted in patients rather than healthy volunteers where comorbidities, disease progression, and lingering effects of other therapies can all …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6342261/
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Safety and efficacy of meplazumab in healthy volunteers …
(Just Now) WebThe phase 1 study is a single-centered, randomized, double-blinded, placebo-controlled trial to evaluate the safety, tolerability, PK, and biodistribution in healthy volunteers.
https://www.nature.com/articles/s41392-021-00603-6
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A Randomized, Placebo-Controlled, Phase 1 Study in Healthy …
(1 days ago) WebMethods In this first-in-human study (NCT05034484), healthy adult volunteers have been enrolled in single ascending dose cohorts of intravenously (IV) or subcutaneously (SC) administered ALPN-303. For each IV cohort, the first 2 sentinel subjects are randomized 1:1 to receive ALPN-303 or placebo, followed by the remaining …
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Frontiers Integration of healthy volunteers in early phase …
(4 days ago) WebIntegration of healthy volunteers in early phase clinical trials with immuno-oncological compounds. An open-label, single-dose, phase 1 study of the absorption, metabolism and excretion of …
https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.954806/full
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Safety, tolerability, pharmacokinetics, and …
(Just Now) WebThis study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509 after oral single rising doses (SRDs) or multiple rising doses (MRDs) in healthy volunteers. In the SRD trial (NCT02694354; February 29, 2016), within each of the three dose groups (DGs), six subjects received BI 685509 (1.0, 2.5, or …
https://link.springer.com/article/10.1007/s00210-024-03165-w
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Phase I trial compensation: How much do healthy volunteers …
(1 days ago) WebMethods: As part of a mixed-methods, longitudinal study of healthy volunteers, we required participants to complete clinical trial diaries, or surveys that captured detailed information about screening and enrollment in Phase I trials. Over a 3-year period, participants provided information online or via telephone about each clinical trial for
https://pubmed.ncbi.nlm.nih.gov/33938244/
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Phase 1 clinical trials - Health Research Authority
(Just Now) WebThe majority of RECs in the UK that are recognised to review Phase 1 clinical trials in healthy volunteers accept Phase 1 applications submitted up to seven days before the meeting date. To make a request for seven-day submission for an application, applicants should contact their preferred REC which is flagged to review Phase 1 clinical trials.
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Colony-Stimulating Factor-1 Antibody Lacnotuzumab in a Phase 1 …
(1 days ago) WebThis phase 1, two-part, double-blind study in healthy volunteers assessed the safety and tolerability of lacnotuzumab and its pharmacokinetics (PK) and pharmacodynamic properties. Part A ( n = 36) was a single, ascending-dose assessment of eight lacnotuzumab doses (0.01-20 mg/kg); in part B ( n = 16), lacnotuzumab was administered at either 5
https://pubmed.ncbi.nlm.nih.gov/30894455/
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Phase I trial compensation: How much do healthy volunteers …
(3 days ago) WebAs part of a mixed-methods, longitudinal study of healthy volunteers, we required participants to complete clinical trial diaries, or surveys that captured detailed information about screening and enrollment in Phase I trials. Resnik DB, Koski G. A national registry for healthy volunteers in phase 1 clinical trials. JAMA 2011; 305: 1236
https://journals.sagepub.com/doi/full/10.1177/17407745211011069
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LSO-090 A placebo-controlled phase 1 study in healthy adult …
(4 days ago) WebThis study was designed to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of povetacicept in adult healthy volunteers (HV). Methods In this first-in-human study ([NCT05034484][1]), 66 adult HV were randomized 4:2 into single ascending dose cohorts of intravenous (IV) or subcutaneous (SC) povetacicept or placebo.
https://lupus.bmj.com/content/10/Suppl_1/A91
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Phase 1 healthy volunteer willingness to participate and …
(1 days ago) WebConclusion: Our results suggest that healthy volunteers are willing to participate in a wide range of types of phase 1 clinical trials, and express preferences for low risk and familiar studies and study procedures, preferences which are partially affected by offers of payment. Keywords: Phase 1 clinical trials; decision-making; healthy
https://pubmed.ncbi.nlm.nih.gov/28766409/
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CSF-1 Antibody Lacnotuzumab in a Phase 1 Healthy Volunteer …
(5 days ago) Webstudy was conducted in accordance with Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Study Design. The clinical trial was a phase 1, two-part, double-blind, randomized, placebo-controlled study conducted in healthy volunteers between August 2010 and May 2013. The randomization scheme was …
https://jpet.aspetjournals.org/content/jpet/early/2019/03/20/jpet.118.254128.full.pdf
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Serial Participation and the Ethics of Phase 1 Healthy Volunteer
(2 days ago) WebPhase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place. a longitudinal study of 180 healthy volunteers participating in phase 1 research in diverse clinics across the United States. We opted for a case study approach, rather than reporting on all
https://academic.oup.com/jmp/article/43/1/83/4803095
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Healthy Volunteers Clinical Center Home Page
(4 days ago) WebWhen you select individual studies, carefully review the study overview and eligibility requirements. If you meet the eligibility requirements, call 1-800-411-1222 (TTY 1-866-411-1010). We can provide participation details on up to three studies a day. Ask about joining our Clinical Research Volunteer Program registry.
https://clinicalcenter.nih.gov/recruit/volunteers.html
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Safety Considerations in Clinical Drug Development
(1 days ago) WebPhase 1 Trials •Subjects –Healthy volunteers •Less confounding factors –Study population –Phase of product development (1-4) –Product evaluated (small molecule, therapeutic
https://www.fda.gov/media/167535/download
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Phase 1 drug-drug interaction study to assess the effect of …
(9 days ago) WebPreviously, in a Phase 1 oral study of FMGX in healthy volunteers (NCT02957929) , the DDI potential of FMGX as a perpetrator was studied by assessing its effect on the Geneva cocktail of CYP substrates, with six unique probe substrates primarily metabolized by CYPs 1A2, 2B6, 2C9, 2C19, 2D6, and 3A4, respectively administered …
https://journals.asm.org/doi/10.1128/aac.01650-23
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Healthy volunteers in first‐in‐human oncology drug …
(5 days ago) Webthis paper using the following main search terms: healthy volunteers, phase 1, first-in-human, pharmacokinetics in oncology, small molecules, cancer or oncology drug. Also, ClinicalTrials.gov was reviewed to sea- study packages can vary greatly depending on the type of compound (small or large molecules, cellular or gene therapies) and the
https://bpspubs.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/bcp.15092?download=true
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Phase 1 healthy volunteer willingness to participate and …
(3 days ago) WebConclusions. Our results suggest that healthy volunteers are willing to participate in a wide range of types of phase 1 clinical trials, and express preferences for low risk and familiar studies and study procedures, preferences which are partially affected by offers of payment. Keywords: Phase 1 clinical trials, research ethics, decision
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6010312/
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CMR provides comparable measurements of diastolic function as …
(Just Now) WebPatients with suspected or diagnosed cardiomyopathy (n = 63) and healthy volunteers (n = 24) were prospectively recruited and included in the study. On the phase 1 image (i.e. end-diastole
https://www.nature.com/articles/s41598-024-61992-6
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Effects of sintilimab plus chemotherapy as first-line treatment on
(3 days ago) WebTo the best of our knowledge, this is the first study of HRQoL exclusively in patients with advanced ESCC in a double-blind, phase 3 study evaluating the first-line PD-1 inhibitor plus chemotherapy. The randomized and double-blind design reduced bias in patient-reported outcomes compared with an open-label design which may introduce bias due to
https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00202-5/fulltext
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Effects of Semaglutide on Chronic Kidney Disease in Patients with …
(1 days ago) WebWe randomly assigned patients with type 2 diabetes and chronic kidney disease (defined by an estimated glomerular filtration rate [eGFR] of 50 to 75 ml per minute per 1.73 m 2 of body-surface area
https://www.nejm.org/doi/full/10.1056/NEJMoa2403347
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Adult Healthy Volunteer Studies Enrolling at Yale
(9 days ago) WebClinical trial looking for healthy volunteers. If you are 18 to 40 years old and are in good health, you may be eligible to participate in a free and confidential research study investigating how our immune system responds to flu vaccine administered into the skin.. If you enroll, you would be asked to come to the Yale Center for Clinical …
https://medicine.yale.edu/news-article/adult-healthy-volunteer-studies-enrolling-at-yale/
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Phase 1 Healthy Volunteer Study of AL01211, an Oral, Non-brain
(1 days ago) WebAL01211 was evaluated in a Phase 1 healthy volunteer study with single ascending dose (SAD) and multiple ascending dose (MAD) arms, to determine safety, pharmacokinetics including food effect, and pharmacodynamic effects on associated GSLs. In the SAD arm, AL01211 showed a Tmax of approximately 3.5 hours, mean clearance
https://pubmed.ncbi.nlm.nih.gov/38363061/
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Healthy volunteers needed for a research study on cannabigerol
(2 days ago) WebHealthy volunteers needed for a research study on cannabigerol. Healthy adults age 18-55 are needed to take part in a Johns Hopkins research study. Participants will complete an in-person screening session to determine study eligibility. Participants who are eligible and agree to be in the study will complete five drug administration sessions
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Safusidenib Phase 2 Study in IDH1 Mutant Glioma - UCLA Health
(7 days ago) WebPatients with recurrent or progressive histologically confirmed IDH1 mutant WHO Grade 2/3 glioma10 outside Japan, will be enrolled in this study. It was divided into 2 parts. Part 1: Up to 25 patients will be randomized 1:1:1:1:1 (5 patients per group) to receive one of the daily oral doses of safusidenib at 125 mg twice a day (BID), 250 mg BID
https://www.uclahealth.org/clinical-trials/safusidenib-phase-2-study-idh1-mutant-glioma
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Sensors Free Full-Text Can We Target Close Therapeutic Goals
(1 days ago) Web(1) Background: The study aimed to determine the most important activities of the knee joints related to gait re-education in patients in the subacute period after a stroke. We focused on the tests that a physiotherapist could perform in daily clinical practice. (2) Methods: Twenty-nine stroke patients (SG) and 29 healthy volunteers (CG) were …
https://www.mdpi.com/1424-8220/24/11/3416
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Low-dose naltrexone for post-COVID fatigue syndrome: a study …
(4 days ago) WebIntroduction A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this …
https://bmjopen.bmj.com/content/14/5/e085272
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Phase I clinical trials of anticancer drugs in healthy volunteers: …
(3 days ago) WebClinical considerations while designing the study include: limited exposure to drug (maximum 1 or 2 doses), conservative dosing scheme, and cessation of exposure at the first evidence of toxicity in volunteers. Though inclusion of healthy volunteers in clinical trials for anticancer drugs offers certain advantages, extrapolation of results from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3469970/
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中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级 …
(1 days ago) Web探索性研究目的：评价 LL-50 注射液在健康受试者中用于皮下浸润和神经阻滞的有效性。. Objectives of Study：. Main study objective: To evaluate the safety and tolerability of LL-50 injection for subcutaneous infiltration and nerve block in healthy volunteers, and to determine the recommended phase II dose (RP2D
https://www.chictr.org.cn/showproj.html?proj=224149
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India report : 6th polling phase for 58 parliamentary - SBS
(5 days ago) WebThe sixth polling phase on 26 May for 58 parliamentary constituencies records a fall in voting percentage; Under pressure from political parties and rights groups, the Election Commission of India
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A phase 1 study to assess the absolute bioavailability, mass …
(1 days ago) WebThis phase 1, 2-period, study was conducted to assess the absolute bioavailability of mobocertinib (Period 1), as well as mass balance, pharmacokinetics, metabolism, and excretion of [14 C]-mobocertinib (Period 2) in healthy adult males. In Period 1, participants received a single oral capsule dose of 160 mg mobocertinib, followed by a 15
https://pubmed.ncbi.nlm.nih.gov/38789848/
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