Drug Discovery World

JANUARY 9, 2023

Part A of the study investigated the safety and pharmacokinetics of continuous daily dosing of IOA-244 at 10, 20, 40 and 80mg. . These data demonstrate for the first time that a semi-allosteric inhibitor of PI3Kδ can be given to patients safely for long durations with no serious adverse events. . “We

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Drug Discovery World

JULY 25, 2023

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, and psychedelic effect of ascending oral doses of CYB003.

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Drug Discovery World

MAY 24, 2023

The ongoing global Phase I/II clinical trial is a multicentre, open-label study designed to assess the safety, pharmacodynamics, and pharmacokinetics of mRNA-3927 in participants aged one year and older with genetically confirmed PA. The data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

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Drug Discovery World

NOVEMBER 10, 2023

SNS-101, VISTA-blocking monoclonal antibody Sensei Biotherapeutics presented clinical dose escalation data from a Phase I/II study of its SNS-101 monotherapy, which showed well tolerated safety profile, potentially best-in-class pharmacokinetics, and encouraging cytokine release profile across multiple dose cohorts.

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ASPET

JUNE 27, 2024

Secondary VAS and pharmacokinetic (PK) endpoints and adverse events were assessed. Three doses of lenabasum (20, 60, and 120mg) were compared to placebo, and nabilone (3 and 6mg). The primary endpoint was the peak effect (Emax) on a bipolar Drug Liking visual analog scale (VAS). Results : Lenabasum was safe and well tolerated.

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Covalent Modifiers

SEPTEMBER 19, 2023

The primary objective was an assessment of safety; pharmacokinetics, investigator-evaluated antitumor activity, and biomarkers of response and resistance were also assessed. Treatment-related adverse events occurred in 127 patients (93%); grade 3 events occurred in 15 patients (11%) and a grade 4 event in 1 patient (1%).

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The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. All adverse events (AEs) that were possibly or probably related to LYT-100 were mild and transient and there were no discontinuations. 1 Cottin, V.,

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Drug Discovery World

OCTOBER 13, 2022

DDW’s Megan Thomas comments on the presentations, posters and booths at the event and the new addition of the ELRIG Tech Theatre, supported by DDW. . When it comes to metrics of success for an event such as Drug Discovery 2022, the numbers speak for themselves. Over the two days at ExCel, 1554 delegates attended the event.

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Drug Discovery World

JUNE 12, 2023

Those are the beginning of additional manufacturing, scale of chemistry pharmacokinetics, pharmacology assays, development bioanalytical assays, and then moving forward toxicology work to start the initial clinical trials. Then, we move forward with what are called Investigational New Drug enabling studies.

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The Pharma Data

JULY 21, 2021

Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Alta Sciences

AUGUST 28, 2023

The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied.

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Drug Discovery World

APRIL 3, 2024

We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. . “We already have experimental results indicating that CM-352 is highly effective in all major bleeding scenarios, with no signs of toxicity, thrombosis, or off-target adverse effects.

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The Pharma Data

FEBRUARY 12, 2022

Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times. Gilead Lores,Inc.

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Drug Discovery World

APRIL 11, 2024

The company reported that OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favourable safety profile in animal models. OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumour cells.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

However, these types of trials can lead to small, non-comparative safety data sets and do not have the ability to use time-to-event endpoints. Biomarker Endpoints Biomarker endpoints are another helpful way to assess the potential efficacy of both initial dose-finding studies and dose-optimization studies.

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Vial

MARCH 15, 2024

Examples of vendors include: Laboratories : CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others. These collaborations with external vendors are aimed at accessing specialized expertise, technologies, or resources that they may not have in-house.

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The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. Safety and Pharmacokinetics of Islatravir in Study Participants with Severe Renal Insufficiency. Abstract 2361.

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The Pharma Data

MARCH 9, 2022

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Pfizer Inc.

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The Pharma Data

JANUARY 31, 2021

The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of intravenously administered PNT001 in healthy adult volunteers. Three non-serious Grade 1 adverse events were determined to be related to PNT001 or placebo, and all resolved without sequelae.

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The Pharma Data

OCTOBER 6, 2021

The LAAB was well permitted and prelim analyses show adverse events were balanced between the placebo and AZD7442 groups. Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial elixir prefusion F-targeting monoclonal antibody with an extended half- life, in healthy grown-ups. Griffin MP, et al. Yu XQ, et al.

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Drug Target Review

JULY 1, 2024

SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

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The Pharma Data

MARCH 16, 2021

Decreases in serious adverse events, high-grade adverse events and treatment-related adverse events were observed in the second year versus the first year in both treatment arms. The most common serious adverse events were pneumonia (6.7% and 10%, respectively), nasopharyngitis (21.7% and 0%, respectively).

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The Pharma Data

MARCH 20, 2023

Data confirm increases in motor function were sustained at four years and the overall rate of adverse events continued to decrease over the 48 month period, reinforcing the long-term efficacy and safety of Evrysdi. Adverse events (AEs) and serious adverse events (SAEs) were reflective of the underlying disease.

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Drug Discovery World

AUGUST 10, 2022

If CAR T cells attack non-tumour tissue, they can cause significant adverse events leading to organ dysfunction and death 8. Using primers and probes similar to those employed by other PCR techniques, users can measure amplification events across thousands of reactions taking place simultaneously across the droplets. Nature Methods.

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Advarra

JUNE 20, 2023

Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements. Assessing Endpoints A final hurdle faced in oncology trials is trial endpoints, or the event(s) or outcome(s) being measured to determine whether the study intervention is safe and effective.

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives.

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Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? ISM6331 is a Pan-TEAD inhibitor with novel scaffold with good IP space, discovered by Chemistry42.

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The Pharma Data

MARCH 13, 2021

1 Most treatment-emergent adverse events (98.5%) were mild to moderate in severity. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.

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The Pharma Data

NOVEMBER 9, 2020

CAB LA and oral FTC/TDF were both well tolerated and most adverse events were mild or moderate in severity and largely balanced between both treatment arms. The pharmacokinetic tail—will this be a significant risk for drug resistance? It also has a long pharmacokinetic. These results show that CAB LA is significantly.

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The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

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The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

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Drug Discovery World

JULY 20, 2023

Pharmacokinetic and pharmacodynamic modelling in mice and allometric scaling should be used to refine dose strengths for human studies, and the available safety data may need re-evaluating considering predicted dosages. However, despite a known safety profile and mechanism of action, the failure rate of 30% is still high.

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LifeSciVC

APRIL 24, 2024

If adverse events are anticipated, it is important to understand gene dosage for such an effect (e.g., The ideal target is one where modulation will not drive adverse phenotypes in healthy individuals, which is important if one intends on trialing in healthy volunteers in Phase 1 but also gives comfort for chronic target modulation.

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The Pharma Data

FEBRUARY 25, 2021

The most common adverse events included fever (pyrexia; 52%), upper respiratory tract infections (43%), diarrhea (29%), cough (24%), vomiting (24%), constipation (19%) and pneumonia (19%). The CHOP-INTEND scale ranges from 0 to 64, with higher scores indicating better function. mg/kg for Part 2. The study met its primary endpoint.

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The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

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The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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