The Effectiveness of CD388 to Prevent Flu in an Influenza... | NCT05523089

NCT05523089

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
Janssen Pharmaceuticals	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo (Arm 1)	Placebo Comparator	In Cohort 1, up to 30 participants will be randomized to receive a single dose of placebo, administered by subcutaneous (SQ) injection, prior to being inoculated with the influenza challenge virus. Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, additional participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in an extension of this Arm 1, to receive a single dose of placebo by SQ injection prior to viral challenge.	Drug: Saline placebo
CD388 High Dose (Arm 2)	Experimental	In Cohort 1, up to 30 participants will be randomized to receive a single dose of 150 milligrams (mg) CD388, administered by SQ injection, prior to being inoculated with the influenza challenge virus. Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, additional participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in an extension of this Arm 2, to receive a single dose of 150 mg CD388 by SQ injection prior to viral challenge.	Combination Product: CD388
CD388 Low Dose 1 (Arm 3)	Experimental	In Cohort 1, up to 30 participants will be randomized to receive a single dose of 50 mg CD388, administered by SQ injection, prior to being inoculated with the influenza challenge virus. Based on an interim analysis to be performed on data collected from the evaluation of Cohort 1 participants who have completed the inpatient phase at the time the interim analysis is performed, additional participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in an extension of this Arm 3, to receive a single dose of 50mg CD388 by SQ injection prior to viral challenge.

Name	Type	Description	Arm Group Labels	Other Names
Saline placebo	Drug	Sterile normal saline for injection	Placebo (Arm 1)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Area Under the Viral Load-Time Curve (VL-AUC) After Influenza Viral Challenge	Evaluation of the prophylactic effect of CD388, when compared to placebo, on VL-AUC of influenza challenge virus as determined by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) on nasal samples starting 1 day post viral challenge.	Day 1 (evening [pm]); Days 2, 3, 4, 5, 6, and 7 (morning [am] and pm); Day 8 (am)
Median Area Under the Viral Load-Time Curve (VL-AUC) After Influenza Viral Challenge	Evaluation of the prophylactic effect of CD388, when compared to placebo, on VL-AUC of influenza challenge virus as determined by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) on nasal samples starting 1 day post viral challenge.	Day 1 (evening [pm]); Days 2, 3, 4, 5, 6, and 7 (morning [am] and pm); Day 8 (am)

Secondary Outcomes

Measure	Description	Time Frame
Mean Peak Viral Load by qRT-PCR After Influenza Viral Challenge	Evaluation of the effect of CD388, when compared to placebo, on the peak (i.e., maximum) viral load of influenza as determined by quantifiable qRT-PCR measurements in nasal samples starting 1 day post viral challenge.	Day 1 (pm); Days 2, 3, 4, 5, 6, and 7 (am and pm); Day 8 (am)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed.
Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.
A total body weight ≥50 kilograms (kg) and body mass index (BMI) ≥18 kg/meter squared (m^2) and ≤35kg/m^2.
In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests as determined by the Principal Investigator (PI)/investigator.
Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
The following criteria are applicable to female participants participating in the study.
1. Females of childbearing potential must have a negative pregnancy test prior to enrolment.
2. Females of non-childbearing potential:
  1. Postmenopausal females defined as amenorrhea for ≥12 months with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within appropriate postmenopausal range, may be used to confirm postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there is <12 months of amenorrhea 2 FSH samples are required at least 4 to 6 weeks apart.
  2. Documented status as being surgically sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
The following criteria apply to female and male participants:
1. Female participants of childbearing potential must use 1 form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 5 effective half-lives (205 days) after the last dose of investigational medicinal product (IMP). Highly effective contraception is as described below:
  1. Established use of hormonal methods of contraception described below (for a minimum of 30 days prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide:
    - a) combined (estrogen- and progestogen containing) hormonal contraception associated with inhibition of ovulation:
      - (i) oral
      - (ii) intravaginal
      - (iii) transdermal
    - b) progestogen-only hormonal contraception associated with inhibition of ovulation:
      - (i) oral
      - (ii) injectable
      - (iii) implantable
  2. Intrauterine device.
  3. Intrauterine hormone-releasing system.
  4. Bilateral tubal ligation.
  5. Male sterilization (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomized male is the sole partner for that woman.
  6. True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant.
2. Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 5 effective half-lives (205 days) after the last dose of IMP.
  1. Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male or female) to the IMP.
  2. Male sterilization with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study.
  3. In addition, for female partners of childbearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned above for female participants.
  4. True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant.
3. In addition to the contraceptive requirements above, male participants must agree not to donate sperm following discharge from quarantine until 5 effective half-lives (205 days) after the last dose of IMP.
Sero-suitable for the challenge virus. A participant must be sero-suitable to take part in the study, i.e., he/she must have no or low pre-existing serum levels of antibodies specific to the challenge agent. Serology testing will be carried out by a hemagglutination inhibitory assay to determine serum antibody titers. As an example, a participant is considered sero-suitable if their serology (hemagglutination inhibition [HAI]) titer result is ≤10.

Exclusion Criteria:

History of, or currently active, symptoms or signs suggestive of upper respiratory tract (URT) or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, hematological, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the PI/investigator may interfere with a participant completing the study and necessary investigations. The following conditions apply:
1. Participants with a history of resolved depression and/or anxiety 1 or more years ago can be included if the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder Questionnaire (GAD-7) is less than or equal to 4 on admission. Participants with a history of stress-related illness, which is not ongoing or requiring current therapy, with good evidence of preceding stressors may be included at the PI's discretion. As required, participants will be assessed prior to enrolment with a PHQ-9 and GAD-7 questionnaire.
2. Rhinitis (including hay fever) which is clinically active or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI's discretion.
3. Atopic dermatitis/eczema which is clinically severe and/or requiring moderate to large amounts of daily dermal corticosteroids will be excluded. Participants with mild to moderate atopic dermatitis/eczema, taking small amounts of regular dermal corticosteroids may be included at the PI's discretion.
4. Any concurrent serious illness, including history of malignancy, that may interfere with a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
5. Participants reporting physician-diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion.
6. Participants with physician diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI.
7. Participants with a history of asthma where their last symptoms/treatment were in adolescence and over 6 years ago may be included at the discretion of the PI. Any participants with symptoms or treatment in adulthood would be excluded.
Any participants who have smoked ≥10 pack years at any time (10 pack years is equivalent to 1 pack of 20 cigarettes a day for 10 years).
Females who:
1. Are breastfeeding, or
2. Have been pregnant within 6 months prior to the study, or
3. Have a positive pregnancy test at any point during screening or prior to dosing with IMP.
Lifetime history of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug in the last 12 months, as assessed by the PI.
Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
. .
1. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
2. Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalized due to epistaxis on any previous occasion.
3. Any nasal or sinus surgery within 3 months of the first study visit.
. .
1. Evidence of vaccinations within the 4 weeks prior to the planned date of dosing with IMP.
2. Intention to receive any vaccination(s) before the last day of follow-up (with the exception of vaccinations recommended for Coronavirus Disease 2019 [COVID-19] as defined by Medicines and Healthcare products Regulatory Agency (MHRA)/government vaccination guidelines).
3. No travel restrictions apply after the Day 28 [±3 days] follow-up visit; however, we expect participants to be available to attend the clinic at the Day 60, Day 120, and Day 180 follow-up visits.
4. Receipt of influenza vaccine in the last 6 months prior to the planned date of viral challenge.
Receipt of blood or blood products, or loss (including blood donations) of 550 milliliters (mL) or more of blood during the 3 months prior to the planned dosing with IMP or planned during the 3 months after the final visit.
. .
1. Receipt of any investigational drug within 3 months prior to the planned date of dosing with IMP.
2. Receipt of 3 or more investigational drugs within the previous 12 months prior to the planned date of dosing with IMP.
3. Prior inoculation with a virus from the same virus-family as the challenge virus.
4. Prior participation in another human viral challenge (HVC) study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study.
Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows, unless in the opinion of the study physician/PI, the medication will not interfere with the study procedures or compromise participant safety. Specifically, the following are excluded:
1. Herbal supplements within 7 days prior to the planned date of dosing with IMP.
2. Chronically used medications, vitamins, or dietary supplements within 21 days prior to the planned date of dosing with IMP.
3. Over-the-counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 7 days prior to the planned date dosing with IMP has exceeded the maximum permissible 24-hour dose (e.g., ≥4 grams paracetamol over the preceding week).
4. Systemic antiviral administration within 4 weeks of the planned date of dosing with IMP.
. .
1. Confirmed positive test for drugs of misuse and cotinine on first study visit. One repeat test is allowed at PI discretion.
2. Recent history or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine, or a measure of spirits), or excessive consumption of xanthine-containing substances (e.g., daily intake in excess of 5 cups of caffeinated drinks, e.g., coffee, tea, cola).
A forced expiratory volume in 1 second (FEV1) <80 percent.
Positive human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) test (HIV positive - via 3 confirmatory tests - Vidas, Genenius, and Determine; HBV confirmed via hepatitis B surface antigen [HbsAG], hepatitis B surface antibody [anti-HBs], and hepatitis B core antibody [anti-HBc] [immunoglobulin G/immunoglobulin M]; and HCV confirmed via hepatitis C viral load).
Presence of fever, defined as participant presenting with a temperature reading of ≥37.9 degrees Celsius (°C) on Day -7/-6 and/or pre-dose on Day -5.
Those employed or immediate relatives of those employed at hVIVO Services Limited (hVIVO) or the sponsor.
Any other finding that, in the opinion of the PI/investigator, deems the participant unsuitable for the study.

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Ozlem Equils, MD	Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Study Director
Arun Anandakumar, MD	hVIVO Services Limited	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
hVIVO Services Limited		London		E1 2AX	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41060047	Derived	Rojas RE, Equils O, Villacian J, Mann A, van Duijnhoven W, Vingerhoets J, Baguet T, Wang SS, Anandakumar A, Anger A, Tourneroche A, Silva IG, Flanagan S. Prophylactic Efficacy of CD388, a Novel Drug-Fc Conjugate, in a Human Influenza A/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study. Clin Infect Dis. 2025 Dec 24;81(5):e310-e318. doi: 10.1093/cid/ciaf465.

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Up to 30 participants randomized to receive a single dose of saline placebo, administered by subcutaneous (SQ) injection, prior to being inoculated with the influenza challenge virus Saline placebo: Sterile normal saline for injection
FG001	50 mg CD388	Up to 30 participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by SQ injection, prior to being inoculated with the influenza challenge virus CD388: CD388 liquid for injection
FG002	150 mg CD388	Up to 30 participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, prior to being inoculated with the influenza challenge virus CD388: CD388 liquid for injection

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED	All participants received their assigned treatment, and all but 1 participant in the placebo arm received challenge virus.	FG00029 subjects FG0012 subjects FG00228 subjects
COMPLETED	Two participants, both in the placebo arm, discontinued the study prior to completion. For all other participants (n=57), including the participant in the placebo arm who was not inoculated with the challenge virus, the study status was reported as completed.	FG00027 subjects FG0012 subjects FG00228 subjects
NOT COMPLETED		FG0002 subjects FG0010 subjects FG0020 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects FG0010 subjects FG0020 subjects
Lost to Follow-up		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Up to 30 participants randomized to receive a single dose of saline placebo, administered by subcutaneous (SQ) injection, prior to being inoculated with the influenza challenge virus Saline placebo: Sterile normal saline for injection
BG001	50 mg CD388

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Area Under the Viral Load-Time Curve (VL-AUC) After Influenza Viral Challenge

Evaluation of the prophylactic effect of CD388, when compared to placebo, on VL-AUC of influenza challenge virus as determined by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) on nasal samples starting 1 day post viral challenge.

The Per-Protocol Population included all randomized participants who received at least 1 dose of study intervention and were challenged with the study virus, and who have a valid result for at least 80% of the planned qRT-PCR nasal samples from Day 1 (pm) up to Day 8 (am) (i.e., at least 11 out of 14), and who present no major deviations likely to impact the evaluation of the primary efficacy endpoint.

Posted

Mean

Standard Deviation

log[10] copies/milliliter (mL)*hour

Day 1 (evening [pm]); Days 2, 3, 4, 5, 6, and 7 (morning [am] and pm); Day 8 (am)

ID	Title	Description
OG000	Placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Up to 30 participants randomized to receive a single dose of saline placebo, administered by subcutaneous (SQ) injection, prior to being inoculated with the influenza challenge virus Saline placebo: Sterile normal saline for injection

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection site pain	General disorders	MedDRA Version 25.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Cidara Therapeutics, Inc.	858-888-7868		clinicaltrialinfo@cidara.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 6, 2022	Sep 4, 2024	Prot_002.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jul 25, 2023	Jun 20, 2024	SAP_001.pdf

Submission Tracking

Condition Browse Module

ID	Term
D007251	Influenza, Human

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Up to 30 participants randomized to receive a single dose of saline placebo, administered by subcutaneous (SQ) injection, prior to being inoculated with the influenza challenge virus

Saline placebo: Sterile normal saline for injection

EG0000 events0 affected29 at risk

EG0010 events0 affected2 at risk

EG0021 events1 affected28 at risk

EG0031 events1 affected59 at risk

Some values were not computable due to the lack of an event {i.e., the first result equal to not detected (less than the Lower Level of Detection \[\<LLOD\]) after peak measure} at the assessed timepoint.

OG00179.4(24.4 to 143.1)

OG00178.7(24.3 to NA)Some values were not computable due to the lack of an event {i.e., the first result equal to not detected (less than the Lower Level of Detection \[\<LLOD\]) after peak measure} at the assessed timepoint.

OG0010.00(0.0 to 11.0)

OG00174.8(23.3 to 96.2)

OG00121.4(8.3 to 41.0)

OG00114.3(4.0 to 32.7)

OG00110.7(2.3 to 28.2)

OG00114.3(4.0 to 32.7)

Title	Measurements
	OG0004 OG0011 OG0022

Title	Measurements
	OG0004 OG0012 OG0022

Title	Measurements
	OG00016 OG0011 OG00219

Title	Measurements
	OG00021 OG0012 OG00232