The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults

NCT05523089 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CD388.SQ.2.02
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the preventative antiviral activity of CD388, as compared to saline placebo, when administered as a single dose to healthy adult participants in a human viral challenge model of influenza.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• 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 (31)

• Mean Peak Viral Load by qRT-PCR After Influenza Viral Challenge

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

• Median Peak Viral Load by qRT-PCR After Influenza Viral Challenge

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

• Time to Confirmed Negative Test by qRT-PCR After Influenza Viral Challenge

  From Day 1 (pm) until the first confirmed undetectable assessment after peak measurement, assessed up to Day 8 (am)

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

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

• Median Area Under the Viral Load-Time Curve (VL-AUC) by Viral Culture After Influenza Viral Challenge

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

Study Arms (6)

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.

Combination Product: CD388

CD388 Low Dose 2 (Optional Arm 4)

EXPERIMENTAL

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, participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in this Optional Arm 4, to receive a single dose of CD388 lower than 150 mg (TBD based on PK results obtained in the first-in-human study CD388.IM.SQ.1.01, as well as the interim analysis), administered by SQ injection, prior to being inoculated with the influenza challenge virus.

Combination Product: CD388

CD388 Low Dose 3 (Optional Arm 5)

EXPERIMENTAL

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, participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in this Optional Arm 5, to receive a single dose of CD388 lower than 150 mg (TBD based on PK results obtained in the first-in-human study CD388.IM.SQ.1.01, as well as the interim analysis), administered by SQ injection, prior to being inoculated with the influenza challenge virus.

Combination Product: CD388

CD388 Low Dose 4 (Optional Arm 6)

EXPERIMENTAL

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, participants (of a number to be informed by the interim analysis) may be randomized into Cohort 2 in this Optional Arm 6, to receive a single dose of CD388 lower than 150 mg (TBD based on PK results obtained in the first-in-human study CD388.IM.SQ.1.01, as well as the interim analysis), administered by SQ injection, prior to being inoculated with the influenza challenge virus.

Combination Product: CD388

Interventions

Saline placebo DRUG

Sterile normal saline for injection

Placebo (Arm 1)

CD388 COMBINATION_PRODUCT

CD388 liquid for injection

CD388 High Dose (Arm 2); CD388 Low Dose 1 (Arm 3); CD388 Low Dose 2 (Optional Arm 4); CD388 Low Dose 3 (Optional Arm 5); CD388 Low Dose 4 (Optional Arm 6)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Females of childbearing potential must have a negative pregnancy test prior to enrolment.
• Females of non-childbearing potential:
• 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.
• 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:
• 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:
• 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

You may not qualify if:

• 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:
• 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.
• 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.
• Participants with physician diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI.
• 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:
• Are breastfeeding, or
• Have been pregnant within 6 months prior to the study, or
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Cidara Therapeutics Inc.: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

hVIVO Services Limited

London, E1 2AX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41060047 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Cidara Therapeutics, Inc.

clinicaltrialinfo@cidara.com

858-888-7868

Study Officials

• Ozlem Equils, MD

  Cidara Therapeutics Inc.

  STUDY DIRECTOR

• Arun Anandakumar, MD

  hVIVO Services Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: September 9, 2022
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)