HealthyPhase 1NCT05619536
Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects
A Phase 1 study testing CD388 Injection in people with Healthy, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CD388 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 14 Jul 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be of Japanese descent with Japanese parents and grandparents, as determined by subject's verbal report.
- Willing and able to provide written informed consent.
- Males and females 18 to 65 years of age, inclusive.
- A female subject must meet one of the following criteria:
- 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 (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); intrauterine device (with or without hormones); or a double barrier method (e.g., condom and spermicide).
- If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion without reversal surgery) or in a menopausal state (at least 1 year without menses), as confirmed by follicle-stimulating hormone (FSH) levels (≥40 milli-International units [mIU]/milliliter [mL]).
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- A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the first dose of study drug.
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 7 months after study drug administration.
- A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 7 months after the last dose of the study medication.
- Good health and without signs or symptoms of current illness.
- Normal clinical examination, including:
- No physical examination findings that an Investigator determines would interfere with interpretation of study results.
- Screening ECG without clinically significant abnormalities.
- Creatinine clearance (CrCL) ≥80 mL/minute as calculated using the Cockcroft-Gault equation.
- Negative urine screen for drugs of abuse and alcohol at screening and Day -1.
- Body weight ≥50 kilograms (kg) and body mass index (BMI; calculated as weight in kg divided by height in meters [m] squared) between 18.0 and 30.0 kg/m^2, inclusive.
- Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from screening through 30 days after any dose of study drug.
- Subject has adequate venous access for blood collection.
Who cannot join
- History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal necrolysis [TEN]).
- History of any of the following:
- Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, polyethylene glycol [PEG], etc.).
- Chronic immune-mediated disease, positive first-degree family history of autoimmune diseases.
- Atopic dermatitis or psoriasis.
- Bleeding disorder.
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- Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for mental conditions.
- Migraines.
- Syncope, or vasovagal syndrome with injections or blood draws.
- Cardiac arrhythmia considered clinically significant by the Investigator.
- Subjects with one or more of the following laboratory abnormalities at screening as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017):
- Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal [ULN]).
- Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), Grade ≥1 (≥1.25 × ULN).
- Total bilirubin, Grade ≥1 (≥1.1 × ULN).
- Any other toxicity Grade ≥2, except for Grade 2 elevations of triglycerides, low density lipoprotein cholesterol, and/or total cholesterol.
- Any other laboratory abnormality considered to be clinically significant by the Investigator.
- Note: Retesting of abnormal laboratory values that may lead to exclusion will be allowed once without prior asking approval from the Sponsor. Retesting will take place during a scheduled or unscheduled visit during screening. Subjects with a normal value at retest may be included.
- Alcohol or drug addiction in the past 2 years.
- Experiencing symptoms of acute illness or chronic disease within 14 days prior to clinical research unit (CRU) check-in.
- At screening, a positive result for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.
- A positive result at CRU check-in for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR).
- Unwilling to comply with local health policy effective at the time regarding coronavirus disease 2019 (COVID-19). Full COVID-19 vaccination prior to participation is strongly recommended.
- Women who are pregnant or nursing.
- Received any over-the-counter (OTC) medications or nutritional supplements within 7 days, or any prescription medications within 14 days or <5 half-lives prior to dosing, whichever is longest (except for hormonal contraceptives, acetaminophen, or ibuprofen).
- Current nicotine user or has quit habitual nicotine use in the 30 days prior to screening.
- Received any vaccines or immunoglobulins within 28 days prior to dosing (90 days in case of intravenous immunoglobulin [IVIg] or biologics, or 14 days for COVID-19 vaccine).
- Donated blood (within 56 days of screening) or plasma (within 7 days of screening) or experienced significant blood loss or significant blood draw (blood donation or blood loss ≥500 mL) when participating in non-interventional clinical trials within 30 days prior to dosing.
- Received a blood transfusion within 28 days prior to dosing.
- Received any biologics within 90 days prior to dosing; or previous participation in another study (including investigational device studies) within 30 days of dosing or 5 half-lives of the study drug, whichever is longer, prior to screening (prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable).
- Previous treatment with CD388.
- Preplanned surgery at any time during the study.
- The Principal Investigator (PI) considers that the volunteer should not participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Los Angeles, Inc.
Cypress, California, 90630
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese Subjects
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.
Read the detailed description
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD388 Injection administered SQ to healthy Japanese adult subjects. The goals are to assess safety, tolerability, and pharmacokinetics (PK) of CD388.
- Conditions
- Healthy
- Being tested
- CD388 Injection, Saline placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD388 InjectionCombination product
CD388 liquid for injection
Saline placeboDrug
Sterile normal saline for injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 9 subjects randomized in a 7:2 ratio to receive either 50 mg CD388 SQ injection or matching placebo injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 2 | Experimental | 9 subjects randomized in a 7:2 ratio to receive either 150 mg CD388 SQ injection or matching placebo injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 3 | Experimental | 9 subjects randomized in a 7:2 ratio to receive either 450 mg CD388 SQ injection or matching placebo injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Number of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Measured: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)
Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Severity of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Measured: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)
Secondary outcomes (7)
Maximum Plasma Concentration (Cmax) Following CD388 Injection Administration
Evaluation of the maximum plasma concentration (Cmax) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Time to Maximum Plasma Concentration (Tmax) Following CD388 Injection Administration
Evaluation of the time to maximum plasma concentration (Tmax) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Terminal Elimination Half-life (t½) Following CD388 Injection Administration
Evaluation of the terminal elimination half-life (t½) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Apparent Clearance (CL/F) Following CD388 Injection Administration
Evaluation of the apparent clearance (CL/F) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Apparent Volume of Distribution (VZ/F) Following CD388 Injection Administration
Evaluation of the apparent volume of distribution (VZ/F) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-last]) Following CD388 Injection Administration
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-last]) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following CD388 Injection Administration
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following subcutaneous administration of a single dose of CD388.
Measured: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start18 Oct 2022
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ozlem Equils, MD, Study director, Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Youngjun Kim, MD, Principal investigator, Altasciences Clinical Los Angeles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619536
- Sponsor's protocol ID
- CD388.SQ.1.03
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2022
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Subcutaneous Administration in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT05619536
- Acronym / sponsor ID
- CD388.SQ.1.03
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD388 Injection administered SQ to healthy Japanese adult subjects. The goals are to assess safety, tolerability, and pharmacokinetics (PK) of CD388.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Combination Product: CD388 Injection, Drug: Saline placebo9 subjects randomized in a 7:2 ratio to receive either 50 mg CD388 SQ injection or matching placebo injection |
| Cohort 2 | Experimental | Combination Product: CD388 Injection, Drug: Saline placebo9 subjects randomized in a 7:2 ratio to receive either 150 mg CD388 SQ injection or matching placebo injection |
| Cohort 3 | Experimental | Combination Product: CD388 Injection, Drug: Saline placebo9 subjects randomized in a 7:2 ratio to receive either 450 mg CD388 SQ injection or matching placebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Must be of Japanese descent with Japanese parents and grandparents, as determined by subject's verbal report.
- Willing and able to provide written informed consent.
- Males and females 18 to 65 years of age, inclusive.
- A female subject must meet one of the following criteria:
- A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the first dose of study drug.
Key exclusion criteria (33 listed)
- History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal necrolysis [TEN]).
- History of any of the following:
- Subjects with one or more of the following laboratory abnormalities at screening as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017):
- Alcohol or drug addiction in the past 2 years.
- Experiencing symptoms of acute illness or chronic disease within 14 days prior to clinical research unit (CRU) check-in.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD388 InjectionCD388 liquid for injection | Combination product | Cohort 1, Cohort 2, Cohort 3 |
| Saline placeboSterile normal saline for injection | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Time frame: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)
Number of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Time frame: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)
Severity of TEAEs reported, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
7 secondary outcomes
Maximum Plasma Concentration (Cmax) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Time to Maximum Plasma Concentration (Tmax) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Terminal Elimination Half-life (t½) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Apparent Clearance (CL/F) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Apparent Volume of Distribution (VZ/F) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-last]) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following CD388 Injection Administration
Time frame: At inpatient visits on Days 1, 2, 3, 4, 5, 6, 7, 9, 11, and 14; and at outpatient visits on Day 30 (±3 days), Day 45 (±3 days), Day 60 (±5 days), Day 90 (±7 days), and either Day 120 (±14 days) (Cohort 1 only) or Day 165 (±14 days) (Cohorts 2 and 3 only)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem Equils, MD study director
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Youngjun Kim, MD principal investigator
Altasciences Clinical Los Angeles, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD388 Injection in people with Healthy, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388 (time frame: From Day 1 through the final study visit (Day 120 for the 50 mg dose arm; Day 165 for all others)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.