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First-in-human Study of Orally Administered KT-579 in Healthy Adult Participants

ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKymera Therapeutics, Inc.

About this trial

This is a first-in-human study to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of single and multiple dose levels of KT-579 in healthy male and female adult participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants 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 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.

Disqualifiers

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 (e.g. 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 2 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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • KT-579

    Drug

    Oral drug

  • Placebo

    Drug

    Oral drug

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: KT-579Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Time frame
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
2

Incidence of serious adverse events

Time frame
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Secondary outcomes

1

Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data

Time frame
Day 1 (SAD); Day 1, Day 7, and Day 14 (MAD)
2

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)
3

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)
4

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)

Other outcomes

1

Change from baseline in IRF5 protein levels in whole blood and peripheral blood mononuclear cells (SAD)

Time frame
Day 1
2

Change from baseline in IRF5 protein levels in whole blood, peripheral blood mononuclear cells, and skin (MAD)

Time frame
Day 1 to Day 14

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kymera Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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