A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study To Assess The Safety, Tolerability, Pharmacokinetics Of Two Monoclonal Antibodies In Healthy Volunteers - Safety, tolerability and PK of Two Monoclonal Antibodies

Aerium Therapeutics0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月9日

试验速览

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•1. Male or female subjects at least 18 years old and less than 50 years of age
•at first screening visit.
•2. Subject has provided written informed consent prior to any trial-related
•3. SARS-CoV-2 confirmed negative by RT-PCR in a nasopharyngeal, oropharyngeal,
•or respiratory sample at <= 72 hours before randomization and administration of
•IMP or placebo on Day 1 (all efforts should be made to complete this test as
•close as possible to Day 1).
•4. Subject is in good health and stable medical condition based on medical
•history, physical examination, laboratory findings, vital signs and ECG (as
•assessed by the investigator within 21 days prior to Day 1).
•5. Willingness and ability to comply with the protocol.
•6. For female subject of childbearing potential with a fertile male sexual
•partner: the use of an adequate contraception from at least 4 weeks prior to
•the first administration of the IMPs until 90 days after the last intake of the
•IMP. Male subjects must agree to use adequate contraception from the first
•administration of the IMP until 90 days after the last intake of the IMP.
•7. BMI of 18.0 to 32.0 kg/m2, inclusive, at screening.
•8. Weight: >=50 kg.

•1. History of any clinically significant medical condition, as assessed by the
•investigator, that may confound the results of the study or poses an additional
•risk to the subject by study participation.
•2. History of any hospitalization (>24 hours) within 30 days of first screening
•3. History of infection with HIV, HCV and HBV.
•4. History of alcohol or drug abuse as determined by the investigator.
•5. History of any significant allergic reaction to prescription or
•non-prescription drugs or food, as determined by the investigator.
•6. Female who is pregnant, lactating, breastfeeding or planning to become
•pregnant within 90 days after the last intake of IMP.
•7. Participation in any clinical research study evaluating another
•investigational drug or device within 3 months of the first screening visit.
•8. The use of other medications with the possibility for adverse reactions
•and/or difficulties in the interpretation of results, as determined by the
•investigator.
•9. Subjects who have received a COVID-19 vaccine or a booster at least 2 weeks
•prior to screening or planning to receive the vaccine or the booster prior to
•Day 29 following the first dose of study drug.

发起方

Aerium Therapeutics