2023-505020-57-00已完成2 期
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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of MMIDa as measured by the InFLUenza Patient Reported Outcome (FLU-PRO) Plus©.
研究概览
简要总结
To determine the effect of CR9114 on reducing the incidence of MMID. To determine the safety and tolerability of CR9114.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of MMIDa as measured by the InFLUenza Patient Reported Outcome (FLU-PRO) Plus©.
Incidence of MMIDa as measured by the InFLUenza Patient Reported Outcome (FLU-PRO) Plus©.
Frequency and severity of treatment-emergent adverse events (TEAE) and SAEs.
Frequency and severity of treatment-emergent adverse events (TEAE) and SAEs.
次要结局
- Area under the curve (AUC) of the influenza ribonucleic acid (RNA) log10 viral load, Peak influenza RNA log10 viral load, and influenza RNA log10 viral load actual values by time/visit by real-time quantitative reverse transcription PCR (qRT-PCR) starting on the second day after challenge (Day 3) until discharge (Day 11).
- Proportion of participants with infection following challenge virus inoculation as determined by qRT-PCR. Infection is defined as at least 2 consecutive qRT-PCR positive nasopharyngeal swabs starting on the second day after challenge (Day 3).
- Viral shedding duration by qRT-PCR and qCulture.
- Viral shedding quantitation by qRT-PCR and qCulture.
- Symptom duration/time to onset of symptoms/time to symptom resolution/time to peak symptoms/peak symptom score/total clinical symptom score by day/FLU-PRO domain/system score as measured by the FLU-PRO Plus©.
- Total number of symptoms experienced with or without laboratory-confirmed influenza illness as measured by the FLU-PRO Plus© and qRT-PCR.
- Number of participants with upper respiratory tract infection, lower respiratory tract infection, systemic illness as measured by the FLU-PRO Plus©.
- Proportion of participants with FLU-PRO Plus© score 3 or higher among participants with and without laboratory-confirmed influenza illness as measured by the FLU-PRO Plus© and qRT-PCR.
- Proportion of participants without symptoms as measured by the FLU-PRO Plus©.
- Proportion of participants without laboratory-confirmed influenza as measured by qRT-PCR.
- PK of CR9114 in serum.
- Presence of anti-CR9114 Abs in serum.
研究者
Zoltán Magyarics
Scientific
Leyden Laboratories B.V.
研究点 (1)
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