NCT06609460已完成2 期
A Phase 2b Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study to Evaluate Efficacy and Safety of CD388, a Novel Long-acting Antiviral Conjugate, for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)99 个研究点 分布在 2 个国家目标入组 5,071 人开始时间: 2024年9月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5,071
- 试验地点
- 99
- 主要终点
- Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.
详细描述
This is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter dose selection study to evaluate the efficacy, safety, and tolerability of 3 dose levels of CD388 administered as a single dose via 3 SQ injections in adult participants who are not at risk of developing complications from influenza.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures.
- •Males and females 18 to less than 64 years of age.
- •In the Investigator's clinical judgment, is in stable health at the time of screening and randomization. Participants may not have underlying hematologic, oncologic, renal, autoimmune, and/or cardiopulmonary illnesses or be considered at risk of developing complications from influenza infection per the CDC guidelines (chronic obstructive pulmonary disease [COPD], asthma, immune compromised current cancer [except non-melanomatous skin cancer], or diabetes). Subjects will be included on the basis of medical history and vital signs taken between signing of the informed consent and randomization.
- •Body mass index (BMI; calculated as weight in kilograms [kg] divided by height in meters [m] squared) of 18.0 kg/m^2 to 35.0 kg/m^2 (inclusive).
- •Women of childbearing potential (WOCBP) must:
- •Have a negative pregnancy test (beta-human chorionic gonadotropin [β-hCG]) at screening, AND
- •Be practicing a highly effective, preferably user-independent method of contraception (failure rate of less than 1 percent per year when used consistently and correctly) from ≥2 weeks prior to randomization and agrees to remain on a highly effective method from Day 1 until 32 weeks after study drug administration, the end of relevant systemic exposure. The Investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the day of administration of study drug.
- •A woman is considered of childbearing potential (i.e., fertile) following menarche and until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •Female participants must agree not to donate or freeze eggs (ova, oocytes) for future use for the purposes of assisted reproduction from Day 1 until 32 weeks after study drug administration.
- •Male participants must wear a condom when engaging in any activity that allows for passage of ejaculate to another person from Day 1 until 32 weeks after study drug administration. Male participants should also be advised of the benefit for a female partner to additionally use a highly effective method of contraception, as condoms could break or leak.
- •Note: Contraceptive (birth control) use by participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
- •Male participants must agree not to donate sperm from Day 1 until 32 weeks after study drug administration.
- •Participant agrees not to donate blood from Day 1 until 32 weeks after study drug administration.
- •Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary), work with smartphones/tablets/computers, and be willing and able to adhere to the prohibitions and restrictions specified in this protocol. If an appropriate language version is not available for the eDiary assessments, the participant should not be enrolled.
- •Must be willing to provide verifiable identification, has means to be contacted, and is able to contact the Investigator/study site and communicate reliably during participation in the study.
排除标准
- •Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibodies (including crystallizable fragment [Fc] domains), or any of the components of CD388 or placebo.
- •Have been diagnosed with influenza (i.e., with medical history [including verbal] of influenza) within the past 6 months prior to randomization.
- •Has received the current seasonal influenza vaccine prior to screening or is planning to receive the seasonal vaccine during trial participation.
- •Has an acute illness (including acute respiratory illnesses) or body temperature ≥38.0ºC (≥100.4 degrees Fahrenheit [ºF]) within 7 days prior to study drug administration (Note: Enrollment at a later date, subsequent to resolution [within the screening period] is permitted).
- •Has had close contact (including household contacts) with someone with laboratory-confirmed influenza or with someone who has been treated with antiviral therapies for influenza within the past 7 days prior to randomization.
- •Has had close contact (including household contacts) with someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) as defined by the US CDC or has had a positive SARS-CoV-2 test within 10 days prior to screening. Please note SARS-CoV-2 testing is NOT required during screening.
- •Has a serious and/or clinically unstable condition such as psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, Alzheimer's disease, or any other condition for which, in the opinion of the Investigator, participation would not be in the participant's best interest or that could prevent, confound, or limit the protocol-specified assessments.
- •Any history of alcohol or drug abuse within the past 2 years or a positive urine drug screen for drugs of abuse (other than tetrahydrocannabinol [THC]) at screening or Day
- •Note: urine drug screen that is positive for a medication prescribed for treatment of ongoing condition is not exclusionary.
- •Had major surgery (e.g., major cardiopulmonary or abdominal operations) per Investigator judgment within 4 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
- •Screening ECG findings of prolonged QT interval corrected for heart rate using Fridericias formula (QTcF) (greater than 450 milliseconds [msec] in males or greater than 470 msec in females), prolonged PR interval (greater than 220 msec), second- or third-degree heart block, or other clinically significant dysrhythmias.
- •At the time of screening, any finding that may significantly increase the risk of participation in the study, affect the ability to participate in the study, or impair interpretation of the study data.
- •Current or planned participation in another clinical study where study intervention is being administered while participating in the current study. Note: Concurrent enrollment is allowed during the follow-up phase of the other clinical study or in case the study intervention in the other clinical study is a marketed product already approved for another indication - exception being if the other study requires study interventions that could affect the safety assessments of the present study (e.g., clinical laboratory tests).
- •[Exclusion criterion #13 removed during Amendment 1.1-US; placeholder remains to retain numbering of the remaining original exclusion criteria.]
- •Prior receipt within the past 30 days or 5 half-lives (whichever is longer) or anticipated receipt of any drug, vaccine, or other biologic agent (e.g., monoclonal antibodies) administered for the prevention or treatment of influenza.
- •Prior receipt of any experimental drug, vaccine, or biologic agent within the past 90 days or 5 half-lives (whichever is longer).
- •Contraindication to SQ injections and blood draws (e.g., bleeding disorders).
- •Has donated ≥450 mL of blood product (1 unit) for any reason within 30 days of screening or plans to donate blood product during the study.
- •Currently pregnant or breastfeeding, intends to become pregnant or breastfeed, or has a positive pregnancy test during the screening period.
- •Has direct involvement in the proposed study or other studies under the direction of the Investigator, sub-investigators, or study site; is a family member of an individual with such direct involvement; or is an employee of the Sponsor.
- •In the opinion of the Investigator, is unlikely to adhere to the requirements of the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants are randomized to receive placebo by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms.
干预措施: Placebo (Combination Product)
CD388 Low Dose
Experimental
Participants are randomized to receive a low dose of CD388 by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms.
干预措施: CD388 Injection (Combination Product)
CD388 Medium Dose
Experimental
Participants are randomized to receive a medium dose of CD388 by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms.
干预措施: CD388 Injection (Combination Product)
CD388 High Dose
Experimental
Participants are randomized to receive a high dose of CD388 by SQ injection. Participants are randomized at a 1:1:1:1 ratio across the 4 arms.
干预措施: CD388 Injection (Combination Product)
结局指标
主要结局
Percentage of Participants Experiencing Protocol-defined Influenza-like Illness (ILI) Occurring ≥7 Days after and up to 24 Weeks after Administration of Study Drug
时间窗: From Day 8 up to 24 weeks after study drug dosing
Percentage of participants experiencing protocol-defined ILI occurring after administration of CD388, with central laboratory-confirmed reverse-transcriptase polymerase chain reaction positive (RT-PCR+) influenza infection based on the nasopharyngeal (NP) swab result, as compared to placebo.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) after Administration of Study Drug
时间窗: From Day 1 through Day 197/End of Study (EOS) after study drug dosing
Safety and tolerability of CD388, as compared to placebo, will be evaluated by assessing the number of participants with incidences of TEAEs following the administration of study drug. TEAEs include but are not limited to adverse events (AEs), serious adverse events (SAEs), injection site reactions (ISRs), and any potentially clinically significant changes from baseline seen in vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory parameters.
次要结局
- Percentage of Participants Experiencing Protocol-defined ILI Occurring ≥7 Days after and up to 28 Weeks after Administration of Study Drug(From Day 8 up to 28 weeks after study drug dosing)
- Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except with a Lower Threshold for New Onset of Fever(From Day 8 up to 24 weeks after study drug dosing)
- Percentage of Participants Experiencing Protocol-defined ILI (as in Primary Endpoint 1) Except the Influenza Infection is Based on the Midturbinate (MT) Swab Result(From Day 8 up to 24 weeks after study drug dosing)
- Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug(From Day 8 up to 24 weeks after study drug dosing)
- Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥2 Respiratory Symptoms after Administration of Study Drug(From Day 8 up to 24 weeks after study drug dosing)
- Percentage of Participants Experiencing an Influenza Infection AND New Onset of ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom after Administration of Study Drug(From Day 8 up to 24 weeks after study drug dosing)
- Percentage of Participants Experiencing an Influenza Infection, AND New Onset of ≥2 Respiratory Symptoms, OR ≥1 Respiratory Symptom AND New Onset of ≥1 Systemic Symptom, after Administration of Study Drug(From Day 8 up to 24 weeks after study drug dosing)
- Percentage of Participants Experiencing an Influenza Infection AND New Onset of Fever, AND New Onset of ≥2 Respiratory Symptoms, OR New Onset of ≥1 Respiratory Symptom Plus New Onset of ≥1 Systemic Symptom, after Administration of Study Drug(From Day 8 up to 24 weeks after study drug dosing)
- Severity (as Composite Symptom Score) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) Symptom Scale(On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing)
- Severity (as Area Under the Curve [AUC]) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale(On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing)
- Duration (as Time to Symptom Resolution) of Participant Reported Influenza-like Symptoms as Based on the Self-reported Responses to the RiiQ™ Symptom Scale(On Day 1 (pre-dose baseline); and then once daily from the time the participant triggers an ARI Alert in the eDiary until the ARI episode is resolved for a maximum of 29 days per ARI episode, up to 28 weeks after study drug dosing)
- Trough Plasma Concentration at 24 Weeks (C[trough24w]) Following Administration of CD388(Based on sampling done at onsite visits on Day 85 (±3 days) and Day 197/EOS (±7 days))
- Maximum Plasma Concentration (C[max]) Following Administration of CD388(At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days))
- Area Under the Plasma Concentration-Time Curve (AUC) Following Administration of CD388(At onsite visits done on Day 8, Day 29, and Day 85 (each ±3 days) and on Day 197/EOS (±7 days))
研究者
研究点 (99)
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