A First-in-Human Study of ZE66-0205 in Healthy Volunteers
ConditionHealthy Volunteers (HV)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEilean Therapeutics
About this trial
This first-in-human study will evaluate ZE66-0205 in healthy adults. The main purpose is to assess the safety and tolerability of single oral doses and, if evaluated, two doses given on Day 1. The study will also assess how ZE66-0205 is absorbed, distributed, and eliminated from the body and how it affects MALT1 levels in blood cells. Participants will be assigned by chance to receive ZE66-0205 or placebo in sequential ascending-dose cohorts.
Eligibility criteria
Qualifiers
Written informed consent provided before any study-related activities; able to understand the nature, purpose, risks, and possible adverse effects of the study.
Male or female, 18 to 55 years of age, inclusive, at Screening.
Body mass index 18.0 to 32.0 kg/m², inclusive, and body weight no more than 100 kg at Screening.
Medically healthy in the opinion of the Investigator or delegate based on medical history and absence of clinically significant abnormalities, including: no clinically relevant physical-examination findings; systolic blood pressure 90 to 160 mmHg and diastolic blood pressure 50 to 95 mmHg after at least 5 minutes of rest; pulse rate 40 to 100 beats/minute after at least 5 minutes of rest; tympanic body temperature 35.5°C to 37.7°C; and electrocardiogram without clinically significant abnormalities, including QTcF less than 450 msec for males and less than 470 msec for females.
Disqualifiers
History of anaphylaxis or another significant allergy that, in the opinion of the Investigator or delegate, could interfere with study participation.
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease or disorder, including any clinically relevant acute illness within the previous 3 months.
Surgery or hospitalization within 3 months before Screening, or planned surgery during the study.
History of malignant disease within the previous 10 years, except surgically resected squamous-cell or basal-cell skin carcinoma with histopathologically confirmed clear margins.
Trial design
Treatments tested in this trial
- ZE66-0205
- Placebo
Treatment groups
32 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov