KT-621 for Healthy Participants

No longer recruiting at 1 trial location

Overseen By Kymera Medical Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Kymera Therapeutics, Inc.

Disqualifiers: Respiratory, Gastrointestinal, Renal, others

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days for SAD, 38 days for MAD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KT-621, an experimental therapy, in its first human application. Researchers aim to determine its safety and how the body processes it at various doses. Participants will receive either KT-621 or a placebo, a pill with no active medicine, to compare effects. The trial seeks healthy adults willing to adhere to study rules and procedures. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it is likely that you should not be on any regular medications. Please consult with the study team for specific guidance.

Is there any evidence suggesting that KT-621 is likely to be safe for humans?

An earlier study tested KT-621 on healthy adults to assess its safety. Participants received either a single dose or multiple doses of the treatment. The study showed that KT-621 was generally well-tolerated. Most side effects were mild and temporary, such as headaches or slight dizziness. No serious side effects were linked to KT-621. These early results are promising, but further research is needed to fully understand the treatment's safety.

Why do researchers think this study treatment might be promising?

Researchers are excited about KT-621 because it represents a novel approach to treatment. Unlike many traditional treatments that rely on well-known pathways, KT-621 may target a new mechanism of action, potentially offering improved outcomes. Additionally, the oral administration of KT-621, whether as a single or multiple doses, offers convenience and ease for patients, which can enhance adherence to the treatment. This innovative approach could provide a fresh option in treatment strategies, making it a promising development in the field.

What evidence suggests that KT-621 could be effective?

Research has shown that KT-621, which participants in this trial may receive, can effectively lower certain markers linked to inflammation. One study found that KT-621 reduced a marker called TARC, associated with inflammation, by up to 37% by Day 14. Another study demonstrated that KT-621 completely broke down a protein called STAT6, which plays a role in the immune system, in both blood and skin. These findings suggest that KT-621 might be as effective as, or even better than, current treatments like dupilumab, used for conditions such as eczema. Overall, early results are promising for KT-621's potential to help manage inflammatory conditions. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 19 to 55 who can follow study procedures and agree to use contraception. Participants must have a normal weight and BMI, no recent substance abuse, no significant health issues or abnormal lab results that could affect the study.

Inclusion Criteria

Evidence of a personally signed and dated informed consent document

Willingness and ability to comply with study procedures

Agreement to contraception requirements

Exclusion Criteria

Factors, conditions, or diseases that might interfere with treatment compliance or study conduct

Positive alcohol and drug tests at Screening and on admission to the CRU

Abnormal clinical laboratory safety test results at Screening and on admission to the CRU

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-621 or placebo

14 days for SAD, 38 days for MAD

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days for SAD, 38 days for MAD

What Are the Treatments Tested in This Trial?

Interventions

• KT-621

Trial Overview The trial tests KT-621, a new drug taken by mouth, against a placebo in healthy people. It aims to understand how safe it is and how the body processes it when given once or multiple times at different doses.

How Is the Trial Designed?

Group I: KT-621 Active Control 1 Intervention

Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-621.

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+

Published Research Related to This Trial

Ketamine causes cytotoxic effects on human bladder cells in a dose- and time-dependent manner, leading to increased cell permeability and changes in cell cycle progression, which may contribute to bladder interstitial cystitis.

In a mouse model, ketamine treatment resulted in significant downregulation of keratin genes, particularly keratin 14, suggesting that these changes in gene expression play a critical role in the development of ketamine-induced cystitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological effect of ketamine in urothelial cell lines and global gene expression analysis in the bladders of ketamine‑injected mice. Shen, CH., Wang, ST., Lee, YR., et al.[2018]

In a study of 36 patients with ketamine-induced cystitis (KC) and 9 control subjects, KC patients exhibited significantly higher symptom scores and reduced bladder capacity, indicating severe bladder dysfunction related to ketamine use.

The research identified microvascular injury and changes in endothelial cell characteristics as potential mechanisms contributing to bladder dysfunction in KC, highlighting the role of NMDAR1 expression and basement membrane thickening in the affected bladder tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microvascular Injury in Ketamine-Induced Bladder Dysfunction. Lin, CC., Lin, AT., Yang, AH., et al.[2018]

K-601, an herbal formulation for influenza, contains 50 identified components, with 15 major compounds and 17 metabolites found in human plasma, indicating its complex chemical profile.

Pharmacokinetic studies revealed significant differences in how K-601 is absorbed between Chinese and African volunteers, with African subjects showing 4-10 times higher absorption of certain alkaloids, which could influence its efficacy and safety in different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a multicomponent herbal preparation in healthy Chinese and African volunteers. Alolga, RN., Fan, Y., Zhang, G., et al.[2022]

In a study involving 10 healthy volunteers, ketamine significantly reduced the binding of the [(123)I]CNS-1261 ligand to NMDA receptors, indicating its effectiveness as a competitor at the intra-channel PCP/ketamine/MK-801 site.

The results suggest that [(123)I]CNS-1261 is a specific ligand for the NMDA receptor's intra-channel site, which could be useful for studying NMDA receptor dynamics in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine displaces the novel NMDA receptor SPET probe [(123)I]CNS-1261 in humans in vivo. Stone, JM., Erlandsson, K., Arstad, E., et al.[2016]

Ketamine is taken up by specific transporter proteins (OCT1-3) in a way that depends on the concentration and pH, which could influence how it is absorbed in the intestines when taken orally.

The study found that while ketamine interacts with OCT transporters and P-glycoprotein (P-gp), it does not interact with MATE1/2K, suggesting that its absorption and distribution in the body may be primarily affected by these transporters rather than by renal excretion mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affinity of Ketamine to Clinically Relevant Transporters. Keiser, M., Hasan, M., Oswald, S.[2019]

Citations

1. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-late-breaking-oral-presentations

Release Details In the Phase 1 clinical study in healthy volunteers, KT-621 demonstrated complete STAT6 degradation in blood and skin following low daily oral ...

2. drug-dev.com drug-dev.com/kymera-therapeutics-announces-positive-first-in-human-results-from-phase-1-trial-of-a-first-in-class-oral-stat6-degrader/

Kymera Therapeutics Announces Positive First-in-Human ... TARC reduction was observed for all KT-621 dose groups, with median reduction of up to 37% at Day 14. We believe these results are comparable ...

3. investors.kymeratx.com investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-positive-first-human-results-phase

Release Details TARC reduction was observed for all KT-621 dose groups, with median reduction of up to 37% at Day 14. We believe these results are comparable ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07217015

NCT07217015 | A Study of KT-621 Administered Orally to ... This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with moderate-to-severe atopic dermatitis (AD) ...

5. dermatologytimes.com dermatologytimes.com/view/kt-621-shows-strong-phase-1-results-as-first-in-class-oral-stat6-degrader

KT-621 Shows Strong Phase 1 Results as First-in-Class ... The oral degrader produced biomarker reductions consistent with or superior to dupilumab, according to data presented at EADV 2025.