KT-579 for Healthy Subjects

Overseen By Kymera Medical Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Kymera Therapeutics, Inc.

Disqualifiers: Respiratory, Gastrointestinal, Renal, Hepatic, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of KT-579, an experimental treatment, in healthy adults. Researchers will examine how the body processes KT-579 by testing both single and multiple doses. Participants will be divided into groups, with some receiving the actual drug and others a placebo, which contains no active drug. Ideal participants are healthy adults without a recent history of major health issues or substance abuse. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that KT-579 is likely to be safe for humans?

Research has shown that KT-579 was safe in early animal studies. Even at very high doses, KT-579 did not cause harmful effects, indicating the treatment was well-tolerated in animals. The studies used doses up to 200 times higher than those potentially given to humans, yet no negative effects appeared.

These results are encouraging, but this trial marks the first time KT-579 is tested in humans. This phase aims to determine if the treatment is safe and well-tolerated in healthy individuals. While early data suggests KT-579 could be safe, human testing will provide clearer answers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about KT-579 because it introduces a fresh approach to treatment by potentially offering a novel mechanism of action. Unlike typical treatments that might focus on a broad range of targets, KT-579 is being explored for its ability to specifically modulate certain pathways at a cellular level, which could lead to more precise and effective results. Additionally, KT-579 is administered orally, making it more convenient and accessible compared to treatments that require injections or infusions. This combination of targeted action and easy administration has the potential to set KT-579 apart from existing therapies.

What evidence suggests that KT-579 could be effective?

Research has shown that KT-579 appears promising in early studies for treating autoimmune diseases. These studies found that KT-579 can lower disease activity in conditions like inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). In animal tests, KT-579 reduced joint swelling and prevented weight loss. The treatment works by blocking certain proteins that cause inflammation, which helps calm the immune system. These early results suggest that KT-579 could be an effective treatment for inflammatory conditions, but more research is needed.

In this trial, participants will receive either a single oral dose or multiple oral doses of KT-579, or a matched placebo, to further evaluate its effects. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must be willing and able to read, understand, and sign an informed consent form (ICF) which includes compliance with requirements and restrictions listed in the ICF and in this protocol

My weight and BMI are within the required range for my gender.

Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

Participants with a history of alcohol or substance abuse within the previous 2 years

Participants who have previously received KT-579 in another cohort in this study

I have a significant history of serious health conditions in major body systems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single oral dose (SAD) or multiple oral doses (MAD) of KT-579 or placebo

4-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KT-579

How Is the Trial Designed?

Group I: KT-579 Active Control 1 Intervention

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-579.

Group II: Placebo Placebo Group 1 Intervention

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

850+

Citations

1.

investors.kymeratx.com

investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-presents-new-preclinical-ibd-data-kt-579/

Release Details

Prophylactic dosing of KT-579 led to a significant reduction in disease activity score, including protection from body weight loss and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07412288

First-in-human Study of Orally Administered KT-579 ...

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

3.

markets.businessinsider.com

markets.businessinsider.com/news/stocks/kymera-therapeutics-presents-new-preclinical-ibd-data-for-kt-579-a-first-in-class-oral-irf5-degrader-at-digestive-disease-week-1036105757

Kymera Therapeutics Presents New Preclinical IBD Data for ...

Prophylactic dosing of KT-579 led to a significant reduction in disease activity score, including protection from body weight loss and ...

4.

investors.kymeratx.com

investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-presents-new-preclinical-data-kt-579-first/

Kymera Therapeutics Presents New Preclinical Data for KT ...

In RA rodent models, KT-579 achieved a dose-dependent reduction of joint swelling that correlated with inhibition of pro-inflammatory cytokines ...

5.

acrabstracts.org

acrabstracts.org/abstract/potent-and-selective-oral-irf5-degrader-kt-579-demonstrates-in-vitro-and-in-vivo-activity-comparable-or-superior-to-approved-or-clinically-active-agents-in-human-cellular-assays-and-lupus-efficacy-m/

Potent and Selective Oral IRF5 Degrader, KT-579, ...

KT-579 achieved deep depletion (≥90%) across multiple species with low oral doses, and did not show adverse effects at concentrations up to 200-fold the ...

6.

investing.com

investing.com/news/company-news/kymera-presents-preclinical-data-for-ibd-drug-candidate-kt579-93CH-4658547

Kymera presents preclinical data for IBD drug candidate KT ...

In preclinical safety studies, KT-579 did not show adverse effects at all doses tested, according to the company. A Phase 1 healthy ...