A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitoc… (NCT03888716) | Clinical Trial Compass
CompletedPhase 1
A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease
United Kingdom72 participantsStarted 2019-03-18
Plain-language summary
This will be a double blind, randomised, placebo controlled, single and multiple oral dose study conducted in 3 parts: Part A, Part B and Part C. Part A and Part B include healthy volunteers only and will be completed before Part C including patients with primary mitochondrial disease will be initiated. The starting dose in the first cohort of Part A will be 25 mg. The dose level in the additional cohorts will be decided following review of data of the previous cohorts.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
✓. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
✓. Able to perform all protocol-specified assessments and comply with the study visit schedule.
✓. Males or females, of any race, between 18 and 65 years of age, inclusive.
✓. Weight ≥50 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive.
✓. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening and Check in as assessed by the Investigator.
✓. Males or females, of any race, between 18 and 75 years of age, inclusive.
✓. Body mass index between 15.0 and 32.0 kg/m2, inclusive.
Exclusion criteria
What they're measuring
1
Safety: incidence and severity of AEs
Timeframe: Day 15
2
Safety: incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results
Timeframe: Day 15
3
Safety: 12 lead ECG parameters
Timeframe: Day 15
4
Safety: Number of participants with clinically significant abnormal vital signs measurements
Timeframe: Day 15
5
Safety: Number of participants with clinically significant abnormal physical examinations
✕. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including KL1333 or its excipients, unless approved by the Investigator.
✕. History of gastroesophageal reflux disease, gastric erosions, peptic ulcer disease, or gastrointestinal bleeding episodes.
✕. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs including cholecystectomy (uncomplicated appendectomy and hernia repair will be allowed).
✕. History of malignancy of any organ system other than localised basal cell carcinoma of the skin, treated or untreated, within 5 years prior to Screening, regardless of whether there is evidence of local recurrence or metastases.
✕. History of clinically significant illness (except for mitochondrial disease in the patients in Part C) or surgery within 4 weeks prior to Screening, as determined by the Investigator.
✕. History of alcoholism or drug/chemical abuse within 2 years prior to Screening.
✕. Alcohol consumption of \>28 units per week for males and \>21 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
✕. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check in.