First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants | Clari

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First-in-human Study of Orally Administered KT-621 in Healthy Adult Participants | Clari

Primary Outcomes

Incidence of adverse events

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

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

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

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)

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)

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)

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)

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)

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

Eligibility

Min Age

19 Years

Max Age

55 Years

Sex

all

Healthy Volunteers

Yes

View full criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

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