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Clinical Trials
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Prior to testing any drug in humans, it has to have data from non-clinical testing confirming an acceptable safety profile and identifying a safe starting dose in the first trials in humans. Non-clinical testing, which is still mostly done in animals, is performed in order to get preliminary data on safety, toxicity, and pharmacokinetics (PK). Once the drug has successfully passed the stage of non-clinical testing, it can go into phase I trials in humans. Phase I trials have as the primary aim to gather early data on safety, toxicity and PK, and to identify the optimal dose for phase II. The optimal dose is found by treating a limited number of subjects (typically 3) on an initial, very low dose. If no serious toxicity is identified the next three subjects receive a slightly higher dose, and so on, until a dose with an acceptable balance between toxicity and likelihood of therapeutic effect is found. It usually requires a relatively small number of trial subjects (<40) to identify the optimal dose. In oncology, phase I trials are done in cancer patients while in other areas of medicine they are done in healthy volunteers.
New Statistical Designs for Clinical Trials of Immunomodulating Agents
Published in Thomas F. Kresina, Immune Modulating Agents, 2020
Phase I trials are usually conducted to determine the maximum tolerated dose (MTD) of an agent. Biological agents, however, may be most effective when administered at a dose less than the MTD. Hence for trials of biologicals, determining the relationship between dose and a measure of biological response is also an important objective.
Clinical Research
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
In the report, discussion of Phase I trials is included under the heading "Clinical Pharmacology," although some firms (such as Burroughs Wellcome) include all phases of clinical trials under the heading "Clinical Research."
Racial and ethnic diversity of US participants in clinical trials for acne, atopic dermatitis, and psoriasis: a comprehensive review
Published in Journal of Dermatological Treatment, 2022
Anjana Sevagamoorthy, Patrick Sockler, Christine Akoh, Junko Takeshita
We also found relative underrepresentation of White individuals and overrepresentation of non-White and Hispanic individuals in Phase I and II trials compared to Phase III trials. This is consistent with emerging literature that describes overrepresentation of racial and ethnic minority individuals and those of lower socioeconomic status particularly in Phase I trials across a broad spectrum of drugs for various medical conditions (130). Because Phase I trials represent the first studies of new interventions in humans, and they enroll healthy volunteers who do not experience any medical benefit from their participation, they are considered more risky than later phase clinical trials. As a result, Phase I trials provide greater financial incentives to participants that may unduly motivate racial and ethnic minority and lower income individuals to participate in earlier phase versus pivotal trials. As we seek to improve the racial and ethnic representation of clinical trial participants in dermatology, we must also take care to address the inequitable distribution of participants across trial phases.
Vaccine clinical trials in low- and middle-income countries: a brief review of standard, newer and proposed approaches
Published in Expert Review of Vaccines, 2022
Jacqueline Deen, John D Clemens
Phase 1 trials are the first in-human studies following the demonstration of safety and immunogenicity in animal research. The primary objectives of the phase 1 trial are to assess for frequently-occurring adverse events and to obtain initial immunogenicity estimates. Phase I trials usually enroll less than a hundred healthy adults and may be designed either with or without control groups of individuals who do not receive the vaccine. Phase I trials are generally conducted in the country where the candidate vaccine is developed and may be repeated in countries where the vaccine is to be deployed. An early clinical study of WC-BS OCV in 41 healthy adult Swedish participants aged 21–50 years of age showed that the vaccine was safe and immunogenic [13]. Phase 1 studies may also assess different dosing regimens [14].
Treatment of hematological malignancies with T cell redirected bispecific antibodies: current status and future needs
Published in Expert Opinion on Biological Therapy, 2019
Laahn H. Foster, Lawrence G. Lum
XmAb14045 is a full length, immunoglobulin-like CD123/CD3 BsAb designed to enable intermittent dosing. In Phase I trials (NCT02730312), it was administered weekly in 28 day cycles and continued as was tolerated. Twenty-three percent (3/13) of AML patients treated during Part A of the study achieved CR/CRi at the two highest dose levels: 1.3 and 2.3 mcg/kg weekly. No CRs were seen at lower doses. Two responders were bridged to SCT. The third was ineligible for medical reasons but remained in remission at 14+ weeks. CRS was the most common TRAE, observed in 77% of patients (49/64), but generally manageable with pre-medications [42]. JNJ63709178 is another humanized IgG4 CD123/CD3 DuoBody in Phase I/II trials (NCT02715011) that may also offer the advantage of weekly or every 2 week administration.