Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

NCT05285137 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CD388.IM.SQ.1.01
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388

  Number of participants with at least one TEAE, 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, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.

  Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)

• Severity of TEAEs After a Single Dose of CD388

  Maximum severity of TEAEs reported (in participants with at least one TEAE), 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.

  Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)

Secondary Outcomes (30)

• Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388

  Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)

• Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388

  Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)

• Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388

  Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)

• Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388

  Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)

• Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388

  Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)

Study Arms (14)

Cohort 1A (sentinel)

EXPERIMENTAL

Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 1A (main)

EXPERIMENTAL

Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 1B (sentinel)

EXPERIMENTAL

Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 1B (main)

EXPERIMENTAL

Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 2A (sentinel)

EXPERIMENTAL

Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 2A (main)

EXPERIMENTAL

Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 2B (sentinel)

EXPERIMENTAL

Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 2B (main)

EXPERIMENTAL

Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 3A (sentinel)

EXPERIMENTAL

High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 3A (main)

EXPERIMENTAL

High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 3B (sentinel)

EXPERIMENTAL

High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 3B (main)

EXPERIMENTAL

High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 4B (sentinel)

EXPERIMENTAL

Highest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection

Combination Product: CD388 Injection; Drug: Saline placebo

Cohort 4B (main)

EXPERIMENTAL

Highest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection

Combination Product: CD388 Injection; Drug: Saline placebo

Interventions

CD388 Injection COMBINATION_PRODUCT

CD388 liquid for injection

Cohort 1A (main); Cohort 1A (sentinel); Cohort 1B (main); Cohort 1B (sentinel); Cohort 2A (main); Cohort 2A (sentinel); Cohort 2B (main); Cohort 2B (sentinel); Cohort 3A (main); Cohort 3A (sentinel); Cohort 3B (main); Cohort 3B (sentinel); Cohort 4B (main); Cohort 4B (sentinel)

Saline placebo DRUG

Sterile normal saline for injection

Cohort 1A (main); Cohort 1A (sentinel); Cohort 1B (main); Cohort 1B (sentinel); Cohort 2A (main); Cohort 2A (sentinel); Cohort 2B (main); Cohort 2B (sentinel); Cohort 3A (main); Cohort 3A (sentinel); Cohort 3B (main); Cohort 3B (sentinel); Cohort 4B (main); Cohort 4B (sentinel)

Eligibility Criteria

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

You may qualify if:

• 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 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 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) 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 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 until at least 205 days 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 mass index (BMI; weight in kilograms \[kg\] divided by height in meters \[m\] squared) between 18.0 and 32.0 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.

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.
• Subjects with one or more of the following laboratory abnormalities at screening as defined by the 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 Kansas, Inc.

Overland Park, Kansas, 66212, 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

• Debra J Kelsh, MD

  Altasciences Clinical Kansas, 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: March 8, 2022
• First Posted: March 17, 2022
• Study Start: March 14, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: February 27, 2025
• Results First Posted: January 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)