Healthy ParticipantsPhase 1NCT07823205
A Study to Evaluate Different Oral Formulations of KT-621
A Phase 1 study testing KT-621 in people with Healthy Participants, run by Kymera Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase I study to evaluate the relative bioavailability and safety and tolerability of different oral formulations of KT-621 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- KT-621
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with a weight of at least 50 kilograms (kg) if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening.
- 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.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders.
- Participants who have a clinically relevant surgical history (for example, surgery of the GI tract that could interfere with the PK of the study medication). Note: prior appendectomy or cholecystectomy is not exclusionary.
- Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- Participants who have acute GI symptoms at the time of Screening or admission to the CRU (for example, nausea, vomiting, diarrhea, heartburn).
- Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening or on admission to the CRU.
- Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives, or time determined by local requirements (whichever is longer) prior to admission to the CRU.
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- Male participants who do not agree to refrain from sperm donation from admission to the CRU to 90 days after the last dose of KT-621.
- Male participants (and their partners of childbearing potential) and female participants who do not agree to the contraception requirements as specified in the clinical protocol.
- Female participants who are pregnant, lactating, or breastfeeding, or plan to become pregnant during study participation or within 30 days of the last dose of KT-621.
- Female participants with a positive or undetermined pregnancy result at the Screening visit or at admission to the CRU.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Celerion
Lincoln, Nebraska, 68502
About this study
Official title: A Phase 1, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of Different Oral Formulations of KT-621 in Healthy Adult Participants
This is a Phase I study to evaluate the relative bioavailability and safety and tolerability of different oral formulations of KT-621 in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- KT-621
- Keywords
- STAT6, STAT6 degrader, targeted protein degrader
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT-621Drug
KT-621 Reference Oral Formulation
KT-621Drug
KT-621 Test Oral Formulation #1
KT-621Drug
KT-621 Test Oral Formulation #2
| Study group | Role | What they receive |
|---|---|---|
| Part A: KT-621 Test Formulation #1 | Experimental | Participants will receive KT-621 in different oral formulations in a one-way crossover design. Receives: Drug: KT-621 |
| Part B: KT-621 Test Formulation #2 | Experimental | Participants will receive KT-621 in different oral formulations in a one-way crossover design. Receives: Drug: KT-621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of KT-621
Measured: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KT-621
Measured: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of KT-621
Measured: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
Secondary outcomes (2)
Incidence of adverse events
Measured: From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)
Incidence of serious adverse events
Measured: From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start5 Oct 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Parts A and B use an open-label, one-way crossover design in which participants receive KT-621 interventions in a fixed sequence across multiple treatment periods.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kymera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823205
- Sponsor's protocol ID
- KT621-HV-105
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of Different Oral Formulations of KT-621 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07823205
- Acronym / sponsor ID
- KT621-HV-105
- Conditions
- Healthy Participants
- Keywords
- STAT6, STAT6 degrader, targeted protein degrader
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kymera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study to evaluate the relative bioavailability and safety and tolerability of different oral formulations of KT-621 in healthy adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parts A and B use an open-label, one-way crossover design in which participants receive KT-621 interventions in a fixed sequence across multiple treatment periods.
| Arm | Type | Receives |
|---|---|---|
| Part A: KT-621 Test Formulation #1 | Experimental | Drug: KT-621Participants will receive KT-621 in different oral formulations in a one-way crossover design. |
| Part B: KT-621 Test Formulation #2 | Experimental | Drug: KT-621Participants will receive KT-621 in different oral formulations in a one-way crossover design. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with a weight of at least 50 kilograms (kg) if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 32.0 kg/m² (inclusive) at Screening.
- 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.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (10 listed)
- Participants who have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, ophthalmological, or connective tissue diseases or disorders.
- Participants who have a clinically relevant surgical history (for example, surgery of the GI tract that could interfere with the PK of the study medication). Note: prior appendectomy or cholecystectomy is not exclusionary.
- Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- Participants who have acute GI symptoms at the time of Screening or admission to the CRU (for example, nausea, vomiting, diarrhea, heartburn).
- Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening or on admission to the CRU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KT-621KT-621 Reference Oral Formulation | Drug | Part A: KT-621 Test Formulation #1, Part B: KT-621 Test Formulation #2 |
| KT-621KT-621 Test Oral Formulation #1 | Drug | Part A: KT-621 Test Formulation #1 |
| KT-621KT-621 Test Oral Formulation #2 | Drug | Part B: KT-621 Test Formulation #2 |
Primary outcome
Maximum Plasma Concentration (Cmax) of KT-621
Time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of KT-621
Time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC∞) of KT-621
Time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)
2 secondary outcomes
Incidence of adverse events
Time frame: From signing of the ICF through the safety follow-up on Day 33 (Part A) or Day 39 (Part B)
Incidence of serious adverse events
Time frame: From signing of the ICF through the safety follow-up visit on Day 33 (Part A) or Day 39 (Part B)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KT-621 in people with Healthy Participants, run by Kymera Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kymera Medical Director (857-285-5300, clinicaltrials@kymeratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of KT-621 (time frame: Day 1 through Day 24 (Part A); Day 1 through Day 30 (Part B)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.