INCA033989 for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and metabolism of a new treatment called INCA033989, an experimental therapy. Researchers seek to determine its tolerance when administered as a subcutaneous injection or through an IV. The trial seeks healthy adults with no significant medical history who are willing to receive the treatment. Participants will help establish the safety of this new treatment for future studies. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking prescription medications 14 days before the study drug is given, and nonprescription medications 7 days before. However, occasional use of standard-dose acetaminophen, ibuprofen, and standard-dose vitamins is allowed.
Is there any evidence suggesting that INCA033989 is likely to be safe for humans?
Research has shown that INCA033989, administered either as a subcutaneous injection or intravenously, was well tolerated in past studies. These studies found no severe side effects that would prevent patients from continuing treatment. Even at high doses, the treatment remained manageable, suggesting general safety across different levels.
Most patients experienced some side effects, but these were typically manageable. Common side effects did not vary with dosage, indicating a consistent safety profile. Although some serious side effects occurred, they were less common.
Overall, evidence suggests that INCA033989 is fairly safe, with a good track record in previous trials. However, as this is an early-phase study, evaluating safety in larger groups remains important.12345Why do researchers think this study treatment might be promising?
INCA033989 is unique because it explores both subcutaneous (SC) and intravenous (IV) delivery methods, which could offer flexibility in administration depending on patient needs. Unlike existing standard treatments, which often rely on specific delivery methods, this trial is testing the effectiveness of both SC injections in Cohorts 1, 2, and 4, and an IV infusion in Cohort 3. Researchers are excited about INCA033989 because it might offer a new modality of administration, potentially improving patient comfort and compliance.
What evidence suggests that INCA033989 could be effective for healthy adults?
Research has shown that INCA033989 yields promising results for treating certain blood disorders. In earlier studies, nearly all patients with myelofibrosis (MF) who received INCA033989 experienced symptom relief, with 60% reporting a significant reduction in symptom scores. Additionally, many patients with essential thrombocythemia (ET) responded positively, with 90% showing improvement in blood cell counts or function. The treatment is generally well tolerated at various doses, with no major safety issues reported. These findings suggest that INCA033989 could effectively improve symptoms and blood cell function in patients.
In this trial, researchers will administer INCA033989 to healthy adults across different cohorts. Some participants will receive it as a subcutaneous injection, while others will receive it as an intravenous infusion, to further evaluate its safety and tolerability.23678Who Is on the Research Team?
Incyte Medical Monitor
Principal Investigator
Incyte Corporation
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 with a BMI between 18 and 32, no significant medical issues, normal lab results, and willing to follow study rules including avoiding pregnancy. Participants must be able to receive the drug by injection or IV.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of INCA033989 via subcutaneous or intravenous administration
Follow-up
Participants are monitored for pharmacokinetics, safety, and tolerability of INCA033989
What Are the Treatments Tested in This Trial?
Interventions
- INCA033989
Trial Overview
The study is testing how the new drug INCA033989 moves through the body and its safety when given either as an injection under the skin or directly into a vein in healthy volunteers.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
INCA033989 will be administered at protocol defined dose administered as a SC injection.
INCA033989 will be administered at protocol defined dose administered as an IV infusion.
INCA033989 will be administered at protocol defined dose administered as a SC injection.
INCA033989 will be administered at protocol defined dose administered as a SC injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Incyte Corporation
Lead Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
1.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/positive-late-breaking-data-incytes-first-class-mutcalr-targetedPositive Late-Breaking Data for Incyte's First-in-Class ...
The results (N=49) showed that INCA033989 was well tolerated across all dose cohorts (24 to 2,500 mg), with no dose-limiting toxicities observed ...
2.
incytecorp.gcs-web.com
incytecorp.gcs-web.com/news-releases/news-release-details/incyte-announces-new-positive-data-inca033989-its-first-class/Incyte Announces New Positive Data for INCA033989, its First ...
Nearly all MF patients treated with INCA033989 (93.3%; 42/45) experienced improved symptoms, with 60% (27/45) achieving a ≥50% reduction in TSS ...
NCT07448155 | A Study to Evaluate the Pharmacokinetics, ...
This study is being conducted to evaluate the pharmacokinetics, safety, and tolerability of INCA033989 following subcutaneous (SC) or intravenous administration ...
Early Results Demonstrate Safety and Efficacy of Mutant ...
Monotherapy with INCA033989 resulted in an SVR25 at week 24 in 41.7% of patients (overall n = 36), whereas 33.3% achieved SVR35 at the same time ...
5.
library.ehaweb.org
library.ehaweb.org/eha/2025/eha2025-congress/4173810/john.mascarenhas.inca33989.is.a.novel.first.in.class.mutant.htmlINCA33989 IS A NOVEL, FIRST IN CLASS, MUTANT ...
Hematologic responses were achieved after 4 weeks (2 doses) and sustained for at least 8 weeks in 57% (CR) and 68% (CR+PR) of evaluable patients ...
Safety and efficacy of INCA033989, a novel first in class ...
Across all dose cohorts (24 to 2500 mg), no dose-limiting toxicities were observed, and a maximum tolerated dose was not reached; 48/51 pts (94 ...
7.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/484/549193/Safety-and-efficacy-of-the-mutant-calreticulinSafety and efficacy of the mutant calreticulin-specific ...
Pts received 989 (24-2500 mg) intravenously every 2 wks. The primary endpoint was safety and tolerability. Efficacy assessments included spleen ...
Early Results Demonstrate Safety and Efficacy of Mutant ...
Monotherapy with INCA033989 was “super well tolerated,” as described by Dr. Mascarenhas. Any-grade treatment-emergent adverse events were seen ...
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