First-In-Human Clinical Study of the C3 Complement Inhibitor AMY- 101 in Healthy Male Volunteers (NCT03316521) | Clinical Trial Compass
CompletedPhase 1
First-In-Human Clinical Study of the C3 Complement Inhibitor AMY- 101 in Healthy Male Volunteers
United States50 participantsStarted 2017-04-24
Plain-language summary
Safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a Single Ascending Dose (SAD) and a Multiple Dose (MD) of the complement inhibitor AMY-101. A prospective, single-center, open-label, First-In-Human (FIH) clinical study in healthy male volunteers.
Who can participate
Age range18 Years – 60 Years
SexMALE
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Inclusion criteria
✓. Willing and able to give written informed consent for participation in the study.
✓. Healthy male subject aged 18-60 years, inclusive at the time of signing the informed consent.
✓. Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 and weight at least 50 kg.
✓. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
✓. Willing to use condom and contraceptive methods with a failure rate of \< 1% to prevent pregnancy and drug exposure of a partner and to refrain from donating sperm from the date of dosing until three (3) months after dosing of the IMP.
✓. Willing and able to complete all procedures according to the Protocol.
Exclusion criteria
✕. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
✕. History of any Neisseria meningitidis infection
✕. History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within the last 60 days prior to dosing.
✕. History of latent or active tuberculosis, as assessed by the investigator based on chest X-ray and positive Quantiferon-TB Gold test.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
✕. History of any type of malignancy. However, completely resolved minor malignancies, at the discretion of the Investigator, may not be an exclusion criterion (for example: Non-Melanoma Skin Cancer).
✕. Diagnosis of autoimmune, immunologic or rheumatologic disease (eg, systemic lupus erythematosus, rheumatoid arthritis).
✕. Any clinically significant illness, medical/surgical procedure or trauma within four (4) weeks of the administration of IMP.