First-in-human Study of Orally Administered KT-621 in Hea... | NCT06673667

NCT06673667

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KT-621	Active Comparator	Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of KT-621.	Drug: KT-621
Placebo	Placebo Comparator	Each participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
KT-621	Drug	Oral drug	KT-621
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes	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)	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	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)		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)

Secondary Outcomes

Measure	Description	Time Frame
Maximum concentration (Cmax): observed maximum concentrations derived from plasma concentration data		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

Other Outcomes

Measure	Description	Time Frame
Change from baseline in STAT6 protein levels in whole blood and peripheral blood mononuclear cells (SAD)		Day 1
Change from baseline in STAT6 protein levels in whole blood, peripheral blood mononuclear cells, and skin (MAD)		Day 1 to Day 14

Eligibility Module

Eligibility 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.

Facility	Status	City	State	ZIP	Country	Contacts
Celerion		Phoenix	Arizona	85283	United States
Celerion