Healthy Participants StudyPhase 1NCT06673667
First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants
A Phase 1 study testing KT-621 in people with Healthy Participants Study, run by Kymera Therapeutics, Inc. at 2 sites in United States.
Trial summary
This is a first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- KT-621
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2024to 23 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 19 to 55 years (inclusive) at the time of consent, with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening.
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Male participants (and their partners of childbearing potential) and female participants must agree to the contraception requirements as specified in the clinical protocol.
- Female participants may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
- Female participants must have a negative result for pregnancy test at Screening and on admission to the CRU.
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 (eg, surgery of the GI tract that could interfere with the PK of the trial medication) Note: prior appendectomy or cholecystectomy is not exclusionary.
- Participants with a history of alcohol or substance abuse within the previous 5 years.
- 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 test positive for alcohol and drugs of abuse at Screening and on admission to the CRU.
- Participants who have acute GI symptoms at the time of Screening or admission to the CRU (eg, nausea, vomiting, diarrhea, heartburn).
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- Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening and on admission to the CRU.
- Participants who have previously received KT-621 in another cohort in this study.
- Participants who have been dosed with any investigational drug or device in a clinical study within 30 days or 5 half-lives (whichever is longer) of KT-621/placebo administration.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Celerion
Phoenix, Arizona, 85283
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study Designed to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-621 in Healthy Adult Participants
This is a first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants.
- Conditions
- Healthy Participants Study
- Being tested
- KT-621, Placebo
- Keywords
- Phase 1, 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
Oral drug
PlaceboDrug
Oral drug
| Study group | Role | What they receive |
|---|---|---|
| KT-621 | Active comparator | Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-621. Receives: Drug: KT-621 |
| Placebo | Placebo comparator | Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, HbA1c, Lactate dehydrogenase (LDH)
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiratory rate (breaths per minute)
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (degrees Celsius)
Measured: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Secondary outcomes (7)
Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data
Measured: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Time to maximum concentration (Tmax): observed time to achieve maximum concentrations derived from plasma concentration data
Measured: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Area under the curve (AUC0-last): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to the last observed timepoint
Measured: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Area under the curve (AUC0-infinity): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to infinite time
Measured: Day 1 (SAD)
Area under the curve (AUC0-tau): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to end of the dosing interval
Measured: Day 1, Day 7, and Day 14 (MAD)
Terminal elimination half-life (t1/2): elimination half-life calculated using non-compartmental analysis
Measured: Day 1 (SAD) and Day 14 (MAD)
Fraction excreted: Fraction of drug excreted unchanged in urine
Measured: Day 14 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start22 Oct 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673667
- Sponsor's protocol ID
- KT621-HV-101
- Status last verified
- Sep 2025
- First submitted
- 23 Oct 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, First-in-Human, Single and Multiple Ascending Dose Study Designed to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered KT-621 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06673667
- Acronym / sponsor ID
- KT621-HV-101
- Conditions
- Healthy Participants Study
- Keywords
- Phase 1, STAT6, STAT6 degrader, targeted protein degrader
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kymera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 5 Nov 2024 (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 first-in-human study to evaluate safety, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-621 in healthy male and female adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KT-621 | Active comparator | Drug: KT-621Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-621. |
| Placebo | Placebo comparator | Drug: PlaceboEach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants aged 19 to 55 years (inclusive) at the time of consent, with a weight of at least 50 kg if male or 40 kg if female, and a body mass index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening.
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Male participants (and their partners of childbearing potential) and female participants must agree to the contraception requirements as specified in the clinical protocol.
- Female participants may not be pregnant, lactating, or breast-feeding or plan to become pregnant (including ova donation) within 30 days of last study drug administration.
Key exclusion criteria (9 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 (eg, surgery of the GI tract that could interfere with the PK of the trial medication) Note: prior appendectomy or cholecystectomy is not exclusionary.
- Participants with a history of alcohol or substance abuse within the previous 5 years.
- 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 test positive for alcohol and drugs of abuse at Screening and 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-621Oral drug | Drug | KT-621 |
| PlaceboOral drug | Drug | Placebo |
Primary outcome
Incidence of adverse events
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, HbA1c, Lactate dehydrogenase (LDH)
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiratory rate (breaths per minute)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (degrees Celsius)
Time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
7 secondary outcomes
Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data
Time frame: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Time to maximum concentration (Tmax): observed time to achieve maximum concentrations derived from plasma concentration data
Time frame: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Area under the curve (AUC0-last): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to the last observed timepoint
Time frame: Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
Area under the curve (AUC0-infinity): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to infinite time
Time frame: Day 1 (SAD)
Area under the curve (AUC0-tau): Area under the plasma concentration-time curve calculated using non-compartmental analysis from time zero to end of the dosing interval
Time frame: Day 1, Day 7, and Day 14 (MAD)
Terminal elimination half-life (t1/2): elimination half-life calculated using non-compartmental analysis
Time frame: Day 1 (SAD) and Day 14 (MAD)
Fraction excreted: Fraction of drug excreted unchanged in urine
Time frame: Day 14 (MAD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Study, run by Kymera Therapeutics, Inc. at 2 sites 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)). The study lists 9 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 2 Oct 2025.