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Recruiting Phase 1 NCT07422207

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

Phase 1 – testing safety in a small group of people
Conditions: Healthy Volunteers

Sponsor: Meiji Pharma USA Inc.

trial.available_in: БГ
Overview
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
Who can participate
Inclusion Criteria: * Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. * Participant must be in good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests. * Participant must have body weight \> 45 kg at the Screening Visit. * Participant must have a body mass index (BMI) between 18.0 and 30.0 kg/m\^2 at the Screening Visit. BMI = body weight (kg)/(height \[m\])\^2. Exclusion Criteria: * Participant with concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis and systemic fungal infection. * Participant with history of pulmonary infiltrates or pneumonia within 6 months prior to the Screening Visit. * Participant with concurrent or history of autoimmune, cardiac, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, central nervous, mental disorders, and/or hematological function disorders, which, in the judgment of the investigator, may affect participation in this clinical study. * Participant with history and/or presence of malignancy of any organ system (including basal cell carcinoma of the skin), treated or untreated. Other protocol defined inclusion/exclusion criteria could apply.
Locations 1
Australia (1)
Scientia Clinical Reserch Ltd
Sydney , New South Wales
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
01.07.2027
Registry ID
NCT07422207
Source
anzctr
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