54 Participants NeededMy employer runs this trial

KT-621 for Healthy Subjects

KM
Overseen ByKymera Medical Director
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Kymera Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs and tolerates KT-621, a new oral medication, in healthy adults. It tests different versions of the medication to determine which is most effective and safest. Participants must be healthy, weigh at least 110 pounds for men or 88 pounds for women, and be willing to follow the study's guidelines. 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-621 is likely to be safe for humans?

Research on KT-621 remains in its early stages, so detailed safety information is limited. This trial primarily focuses on assessing the treatment's safety for participants. In these initial studies, researchers closely monitor treatments to identify any unwanted effects. They are beginning to understand potential side effects and how well people tolerate KT-621.

If the FDA had already approved KT-621 for other uses, more safety information might be available. However, as a new treatment, additional data is necessary. Participants in this study will contribute valuable information about its safety and potential side effects.12345

Why are researchers excited about this trial's treatments?

KT-621 is unique because it offers a novel approach by providing different oral formulations in a one-way crossover design. Unlike standard treatments, which often involve a single formulation, KT-621's versatility in formulation could lead to more personalized and potentially more effective treatment strategies. Researchers are excited about this treatment because its innovative delivery method might improve absorption and lead to better overall outcomes for patients.

What evidence suggests that this trial's treatments could be effective?

Scientists are in the early stages of researching KT-621, working to understand its mechanism in the body. While specific information on its effectiveness in treating diseases in people is not yet available, researchers are concentrating on its safety and how the body processes it. The goal is to determine its potential for future use. In this trial, participants will receive different formulations of KT-621 to ensure these versions are safe and manageable. This foundational research is crucial before testing its efficacy in treating specific health conditions.678910

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any significant medical conditions. Participants should generally be in good health and able to safely take part in a research study.

Inclusion Criteria

Participants must be willing and able to read, understand, and sign an informed consent form including compliance with requirements and restrictions listed in the ICF and protocol
Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
My weight and BMI are within the required range for my gender.

Exclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant during the study.
I have a significant history of major health problems in one or more body systems.
Participants with clinical laboratory safety test results outside the local reference range at Screening or admission to the clinical research unit
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KT-621 in different oral formulations in a one-way crossover design

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KT-621

Trial Overview

The study is testing different oral forms of a new drug called KT-621 to see how much of the drug gets into the body and how safe it is. All participants will receive KT-621 by mouth.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part B: KT-621 Test Formulation #2Experimental Treatment1 Intervention
Group II: Part A: KT-621 Test Formulation #1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kymera Therapeutics, Inc.

Lead Sponsor

Trials
8
Recruited
850+

Citations

Healthy People 2030 | odphp.health.gov

Healthy People 2030 sets data-driven national objectives to improve health and well-being over the next decade.

Use of the "Healthy" Claim on Food Labeling

The FDA announced on December 19, 2024, a final rule to update the “healthy” claim that manufacturers can voluntarily use on food packages.

HEALTHY Definition & Meaning

The meaning of HEALTHY is enjoying good health : free from disease. How to use healthy in a sentence. Synonym Discussion of Healthy.

Healthy diet

People with diets rich in vegetables and fruit have a significantly lower risk of obesity, heart disease, stroke, diabetes and certain types of cancer. Eat less ...

5.

healthychildren.org

healthychildren.org/

HealthyChildren.org - From the American Academy of Pediatrics

New to HealthyChildren? Register Now. Register now to recieve our monthly HealthyChildren e-newsletter and create your Family Health Center. Already Registered?

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A secure, collaborative, cloud-based high-performance computing environment advancing regulatory science and AI innovation for the FDA.

401 Unauthorized

A secure, collaborative, cloud-based high-performance computing environment advancing regulatory science and AI innovation for the FDA.