Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

NCT05619536 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CD388.SQ.1.03
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  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)

Study Arms (3)

Cohort 1

EXPERIMENTAL

9 subjects randomized in a 7:2 ratio to receive either 50 mg CD388 SQ injection or matching placebo injection

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

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

Combination Product: CD388 Injection; Drug: Saline placebo

Interventions

CD388 Injection COMBINATION_PRODUCT

CD388 liquid for injection

Cohort 1; Cohort 2; Cohort 3

Saline placebo DRUG

Sterile normal saline for injection

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[mL\]).
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

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

Study Sites (1)

Altasciences Clinical Los Angeles, Inc.

Cypress, California, 90630, United States

Location

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

• Youngjun Kim, MD

  Altasciences Clinical Los Angeles, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: October 18, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)