Clinical trials
NAVIGATE
Identifier
NCT06609460
Link
https://clinicaltrials.gov/study/nct06609460
Phase
Phase II
Status
Active, not recruiting
Sponsor
Cidara Therapeutics Inc.
More details
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.
Purpose
Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
Interventions
Intervention 1
CD388 Injection
Dosage: low-SQ
Intervention 2
CD388 Injection
Dosage: high-SQ
Intervention 3
CD388 Injection
Dosage: medium-SQ
Intervention 4
Placebo
Countries
United States of America
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-09-20
Anticipated Date of Last Follow-up
2025-03-12
Estimated Primary Completion Date
2025-09-01
Estimated Completion Date
2025-09-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
1. Willing and able to provide written informed consent and comply with scheduled visits, laboratory tests, and other study procedures.
2. Males and females 18 to less than 64 years of age.
3. 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 a
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
5000
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Prevention
Key resources
CD388.SQ.2.02
Identifier
NCT05523089
Link
https://clinicaltrials.gov/study/NCT05523089
Phase
Phase II
Status
Completed
Sponsor
Cidara Therapeutics Inc.
More details
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.
Purpose
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
Interventions
Intervention 1
Saline placebo
Intervention 2
CD388
Countries
United Kingdom
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-09-09
Anticipated Date of Last Follow-up
2024-09-04
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-07-17
Actual Completion Date
2023-07-17
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
1. Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed.
2. Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.
3. A total body weight ≥50 kilograms (kg) and body mass index (BMI) ≥18 kg/meter squared (m\^2) and ≤35kg/m\^2.
4. 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.
5. Participants will have a d
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
59
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Prevention
Key resources
Not provided
CD388.IM.SQ.1.01
Identifier
NCT05285137
Link
https://clinicaltrials.gov/study/NCT05285137
Phase
Phase I
Status
Completed
Sponsor
Cidara Therapeutics Inc.
More details
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in the muscle or under the skin.
Purpose
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
Interventions
Not provided
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-03-14
Anticipated Date of Last Follow-up
2025-02-12
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-10-27
Actual Completion Date
2023-10-27
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
1. Willing and able to provide written informed consent.
2. Males and females 18 to 65 years of age, inclusive.
3. A female subject must meet one of the following criteria:
1. If of childbearing potential - agrees to use a highly effective, preferably user-independent method of contraception (failure rate of \<1 percent per year when used consistently and correctly) for at least 30 days prior to screening and agrees to remain on a highly effective method until 205 days after last dose of study medication. Examples of highly-effective methods of contraception include: abstinence from heterosexual intercourse; hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); intrauterine device (with or w
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
77
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Prevention
Key resources
Not provided
CD388.SQ.1.03
Identifier
NCT05619536
Link
https://clinicaltrials.gov/study/NCT05619536
Phase
Phase I
Status
Completed
Sponsor
Cidara Therapeutics Inc.
More details
The purpose of this study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when dosed by subcutaneous (SQ) administration as a single dose to healthy Japanese adult subjects.
Purpose
Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects
Interventions
Not provided
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-10-18
Anticipated Date of Last Follow-up
2024-06-24
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2023-07-14
Actual Completion Date
2023-07-14
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Inclusion Criteria:
1. Must be of Japanese descent with Japanese parents and grandparents, as determined by subject's verbal report.
2. Willing and able to provide written informed consent.
3. Males and females 18 to 65 years of age, inclusive.
4. A female subject must meet one of the following criteria:
1. If of childbearing potential - agrees to use a highly effective, preferably user-independent method of contraception (failure rate of \<1 percent per year when used consistently and correctly) for at least 30 days prior to screening and agrees to remain on a highly effective method until 7 months after last dose of study medication, whichever is longer. Examples of highly-effective methods of contraception include: abstinence from heterosexual intercourse; hormonal contraceptives (
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
28
Allocation
Randomized
Intervention model
Sequential assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Not provided
Studied LA-formulation(s)
Not provided
Studied route(s) of administration
Not provided
Use case
Prevention
Key resources
Not provided
ANCHOR
Identifier
NCT07159763
Link
https://clinicaltrials.gov/study/NCT07159763
Phase
Phase III
Status
Not yet recruiting
Sponsor
Cidara Therapeutics Inc.
More details
The purpose of this study is to evaluate how well CD388 works in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, when given as a single dose via 3 subcutaneous (SQ) injections to adult and adolescent participants who are at higher risk of developing influenza complications, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Purpose
A Study to Evaluate the Safety and Efficacy of CD388 for Prevention of Influenza
Interventions
Intervention 1
CD388 Injection
Intervention 2
Placebo
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2025-09-01
Actual Start Date
Not provided
Anticipated Date of Last Follow-up
2025-08-29
Estimated Primary Completion Date
2027-01-01
Estimated Completion Date
2027-01-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
-
Children
-
Adults
-
Older Adults
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Based on feedback from the FDA, the study population has been expanded to include generally healthy adults over 65 years old with no specific co-morbidities in addition to other high-risk populations with certain comorbidities and immune compromised status.
Health status
Negative to
: other
Other health status: Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1.
Study type
Interventional (clinical trial)
Enrollment
5500
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Quadruple-blind masking
Masking description
Not provided
Frequency of administration
Once
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Use case
Prevention
Key resources
Patent info
Description
CD388 structure (linker + zanamivir dimer)
Brief description
Compositions and methods for the treatment of viral infections include conjugates containing inhibitors of viral neuraminidase and MoT influenza or parainfluenza,
Representative patent
WO2021046549
Category
Compound, combination
Patent holder
CIDARA THERAPEUTICS, INC.
Exclusivity
Not provided
Expiration date
September 8, 2040
Status
Granted: ZA, US, CO, AU, JP, NZ, CN
Pending: HK, AE, BR, CA, CL, CR, EA, EC, EP (LMICs: AL, MK, TR, BA, ME, KH, MA, MD, TN, RS), ID, IL, KR, MX, MY, PE, PH, SA, SG, TH, TW, UA, VN, IN
Withdrawn: AP
Description
Zanamivir compound
Brief description
Zanamivir compound (broad Markush, and specific structure as example 3) and method for treating influenza
Representative patent
WO1991016320
Category
Compound
Patent holder
BIOTA SCIENTIFIC MANAGEMENT PTY LTD
Exclusivity
Not provided
Expiration date
November 15, 2011
Status
Expired
