A Phase 2a Randomized, Double-blind, Placebo-controlled Trial with Open-label Dose-finding Cohorts to Evaluate the Efficacy and Safety of CR9114 Monoclonal Antibody Administered as Intranasal Doses in Healthy Adult Participants who are Challenged with a Live, Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2) - F21-CLD-201

eyden Laboratories B.V.0 个研究点目标入组 140 人开始时间: 2023年4月25日最近更新: 2024年7月22日

适应症

试验速览

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•Male or female, between 18 and 55 years old at screening, extremes included., Body Mass Index (BMI) within normal range: 19.0 = BMI = 30.0 kg/m2 at screening and with a minimum weight of 50.0 kg., Healthy in the investigator’s clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead ECG and laboratory assessments performed at screening and/or pre-randomization., Negative hepatitis panel including hepatitis B Virus surface antigen (HBsAg), anti-hepatitis B virus core (HBc) Ab, and anti-hepatitis C virus (HCV) Abs (with reflex HCV RNA, ie, positive for HCV Abs is allowed if negative for HCV RNA) and negative human immunodeficiency virus (HIV) Type 1 and Type 2 Ab screens at screening.

•Any reason that would limit the participant’s ability to complete the trial or might interfere with the primary trial objectives for safety of the trial participant based on the opinion of the investigator., History of severe local or systemic reactogenicity to any medication (eg, anaphylaxis, respiratory difficulties, angioedema)., Known allergy or hypersensitivity to any component of IP or viral challenge agent, including known or suspected egg allergies., Presence of nasal polyps or significant nasal abnormalities or facial muscular paralysis (eg, Bell’s Palsy) and/or history of chronic sinusitis or chronic use (at least 14 days in the 2 months prior to screening) of nasally applied medications.

发起方

eyden Laboratories B.V.