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The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study.
Full description
The study is designed as a 2-part study:
Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each cohorts study Day 1.
Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5 dose levels as determined by the SAD cohort. Doses will be determined following completion and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.
Enrollment
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Inclusion criteria
To be eligible for study entry participants must satisfy all of the following criteria:
Provide written informed consent before any study specific evaluation is performed;
Healthy adult male and female volunteers between the ages of 18 and 65 years, inclusive, at screening;
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
A male patient with a female partner of childbearing potential is eligible to participate if he and his female partner agrees to use acceptable contraception during the treatment period and for at least 30 days after the last dose of study treatment and refrains from donating sperm during this period.
Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening;
Hematology, clinical chemistry, coagulation and urinalysis test results within normal ranges or has no clinically relevant deviations, as determined by the investigator in consultation with sponsor, at screening and Day -1. Tests with out of range values at screening or Day -1 may be repeated once per assessment point;
No clinically significant abnormalities noted in medical history; or discovered by physical examination, ECG assessment, or measurement of vital signs at screening and Day -1;
Able and willing to abstain from alcohol, caffeine or caffeine-containing products, grapefruit or grapefruit juice, St John's wort, and herbal supplements for from 24 hours before Day -1 until the end of the confinement period and for 24 hours prior to additional visits to the study site.
Agree to not engage in heavy exercise (e.g., marathon runners, weight-lifting) within 1 week prior to dosing until the final study visit.
Able and willing to comply with the protocol and study procedures;
Exclusion criteria
Participants will be excluded from the study if one or more of the following criterion are applicable:
Primary purpose
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Interventional model
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90 participants in 6 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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