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NCT05285137

Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects

Completed Phase 1 Results posted Last updated 27 February 2025
What this trial tests

Phase 1 trial testing CD388 Injection in Healthy in 77 participants. Completed in 27 October 2023.

Timeline
14 March 2022
Primary endpoint
27 October 2023
27 October 2023

Quick facts

Lead sponsorCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingquadruple
Primary purposeprevention
Enrollment77
Start date14 March 2022
Primary completion27 October 2023
Estimated completion27 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

Participants with at least one TEAE
GroupValue95% CI
CD388 50 mg IM5
CD388 150 mg IM5
CD388 450 mg IM5
Pooled Placebo IM8
CD388 50 mg SQ5
CD388 150 mg SQ4
CD388 450 mg SQ5
CD388 900 mg SQ3
Pooled Placebo SQ7
Participants with AEs leading to study withdrawal
GroupValue95% CI
CD388 50 mg IM0
CD388 150 mg IM0
CD388 450 mg IM0
Pooled Placebo IM0
CD388 50 mg SQ0
CD388 150 mg SQ0
CD388 450 mg SQ2
CD388 900 mg SQ0
Pooled Placebo SQ0
Severity of TEAEs After a Single Dose of CD388 Primary · 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)

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.

Mild
GroupValue95% CI
CD388 50 mg IM5
CD388 150 mg IM5
CD388 450 mg IM2
Pooled Placebo IM5
CD388 50 mg SQ4
CD388 150 mg SQ4
CD388 450 mg SQ3
CD388 900 mg SQ3
Pooled Placebo SQ6
Moderate
GroupValue95% CI
CD388 50 mg IM0
CD388 150 mg IM0
CD388 450 mg IM3
Pooled Placebo IM2
CD388 50 mg SQ1
CD388 150 mg SQ0
CD388 450 mg SQ1
CD388 900 mg SQ0
Pooled Placebo SQ1
Severe
GroupValue95% CI
CD388 50 mg IM0
CD388 150 mg IM0
CD388 450 mg IM0
Pooled Placebo IM1
CD388 50 mg SQ0
CD388 150 mg SQ0
CD388 450 mg SQ1
CD388 900 mg SQ0
Pooled Placebo SQ0
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM4.13± 0.747
Cohort 2A CD388 150 mg IM10.4± 2.44
Cohort 3A CD388 450 mg IM48.6± 11.7
Cohort 1B CD388 50 mg SQ3.57± 0.942
Cohort 2B CD388 150 mg SQ12.0± 3.35
Cohort 3B CD388 450 mg SQ32.7± 9.40
Cohort 4B CD388 900 mg SQ58.8± 17.5
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM3.962.91 – 5.34
Cohort 2A CD388 150 mg IM10.46.52 – 13.6
Cohort 3A CD388 450 mg IM48.035.2 – 67.7
Cohort 1B CD388 50 mg SQ3.722.17 – 4.83
Cohort 2B CD388 150 mg SQ11.86.84 – 17.0
Cohort 3B CD388 450 mg SQ31.616.6 – 48.0
Cohort 4B CD388 900 mg SQ60.734.3 – 91.3
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM111.08± 72.42
Cohort 2A CD388 150 mg IM159.03± 83.10
Cohort 3A CD388 450 mg IM85.64± 42.19
Cohort 1B CD388 50 mg SQ213.00± 108.43
Cohort 2B CD388 150 mg SQ137.48± 77.82
Cohort 3B CD388 450 mg SQ120.04± 67.83
Cohort 4B CD388 900 mg SQ109.54± 55.66
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM96.0748.17 – 240.00
Cohort 2A CD388 150 mg IM131.9871.97 – 312.00
Cohort 3A CD388 450 mg IM78.3124.17 – 144.00
Cohort 1B CD388 50 mg SQ228.0072.00 – 312.02
Cohort 2B CD388 150 mg SQ131.2848.22 – 312.02
Cohort 3B CD388 450 mg SQ96.0048.17 – 240.00
Cohort 4B CD388 900 mg SQ96.0048.17 – 192.00
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM1234.41± 140.04
Cohort 2A CD388 150 mg IM1192.03± 235.80
Cohort 3A CD388 450 mg IM1006.20± 314.39
Cohort 1B CD388 50 mg SQ1069.78± 216.48
Cohort 2B CD388 150 mg SQ1265.53± 223.93
Cohort 3B CD388 450 mg SQ1065.21± 239.19
Cohort 4B CD388 900 mg SQ1384.36± 282.53
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM1275.62985.09 – 1390.45
Cohort 2A CD388 150 mg IM1285.85783.24 – 1471.71
Cohort 3A CD388 450 mg IM1137.42540.88 – 1384.09
Cohort 1B CD388 50 mg SQ1052.39685.81 – 1350.50
Cohort 2B CD388 150 mg SQ1270.40796.65 – 1576.21
Cohort 3B CD388 450 mg SQ1040.30809.64 – 1502.38
Cohort 4B CD388 900 mg SQ1287.451110.87 – 1998.04
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM0.00751± 0.00119
Cohort 2A CD388 150 mg IM0.00867± 0.00177
Cohort 3A CD388 450 mg IM0.00766± 0.00199
Cohort 1B CD388 50 mg SQ0.00900± 0.00230
Cohort 2B CD388 150 mg SQ0.00725± 0.00123
Cohort 3B CD388 450 mg SQ0.00883± 0.00213
Cohort 4B CD388 900 mg SQ0.00863± 0.00158
Median Apparent Clearance (CL/F) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM0.007070.00614 – 0.00991
Cohort 2A CD388 150 mg IM0.008510.00640 – 0.0112
Cohort 3A CD388 450 mg IM0.007260.00571 – 0.0116
Cohort 1B CD388 50 mg SQ0.008340.00591 – 0.0128
Cohort 2B CD388 150 mg SQ0.007170.00551 – 0.00909
Cohort 3B CD388 450 mg SQ0.009120.00493 – 0.0115
Cohort 4B CD388 900 mg SQ0.008700.00648 – 0.0111
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the apparent volume of distribution (V\[z\]/F) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM13.3± 1.91
Cohort 2A CD388 150 mg IM14.8± 4.40
Cohort 3A CD388 450 mg IM10.7± 2.99
Cohort 1B CD388 50 mg SQ13.4± 2.59
Cohort 2B CD388 150 mg SQ13.3± 3.70
Cohort 3B CD388 450 mg SQ13.1± 2.61
Cohort 4B CD388 900 mg SQ17.1± 3.76
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388 Secondary · 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)

Evaluation of the apparent volume of distribution (V\[z\]/F) following the first single dose of CD388 administered by either IM or SQ injection.

GroupValue95% CI
Cohort 1A CD388 50 mg IM13.910.3 – 15.8
Cohort 2A CD388 150 mg IM14.411.1 – 23.9
Cohort 3A CD388 450 mg IM10.96.47 – 15.1
Cohort 1B CD388 50 mg SQ12.211.4 – 18.7
Cohort 2B CD388 150 mg SQ12.79.27 – 20.7
Cohort 3B CD388 450 mg SQ12.910.7 – 18.9
Cohort 4B CD388 900 mg SQ16.711.2 – 24.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm [Cohorts 1A/1B]; Day 412 for the 150 mg and 450 mg dose arms [Cohorts 2A/2B and 3A/3B]; and Day 206 for the 900 mg dose arm [Cohort 4B]).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CD388 50 mg IM
Serious: 0/8 (0%)
Deaths: 0/8
CD388 150 mg IM
Serious: 0/8 (0%)
Deaths: 0/8
CD388 450 mg IM
Serious: 0/8 (0%)
Deaths: 0/8
Pooled Placebo IM
Serious: 0/9 (0%)
Deaths: 0/9
CD388 50 mg SQ
Serious: 0/8 (0%)
Deaths: 0/8
CD388 150 mg SQ
Serious: 0/8 (0%)
Deaths: 0/8
CD388 450 mg SQ
Serious: 0/8 (0%)
Deaths: 0/8
CD388 900 mg SQ
Serious: 0/8 (0%)
Deaths: 0/8
Pooled Placebo SQ
Serious: 0/12 (0%)
Deaths: 0/12
Other adverse events (65 terms — click to expand)

ReactionSystemCD388 50 mg IMCD388 150 mg IMCD388 450 mg IMPooled Placebo IMCD388 50 mg SQCD388 150 mg SQCD388 450 mg SQCD388 900 mg SQPooled Placebo SQ
HeadacheNervous system disorders
Viral infectionInfections and infestations
DizzinessNervous system disorders
Injection site painGeneral disorders
COVID-19Infections and infestations
Back painMusculoskeletal and connective tissue disorders
PresyncopeNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
NauseaGastrointestinal disorders
SomnolenceNervous system disorders
VomitingGastrointestinal disorders
Saliva discolorationGastrointestinal disorders
DiarrheaGastrointestinal disorders
Non-cardiac chest painGeneral disorders
Feces hardGastrointestinal disorders
ConstipationGastrointestinal disorders
Dermatitis contactSkin and subcutaneous tissue disorders
AcneSkin and subcutaneous tissue disorders
Upper respiratory tract infectionInfections and infestations
Decreased appetiteMetabolism and nutrition disorders
Arthropod biteInjury, poisoning and procedural complications
Pain in extremityMusculoskeletal and connective tissue disorders
PustuleInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
Cerumen impactionEar and labyrinth disorders
PharyngitisInfections and infestations
SunburnInjury, poisoning and procedural complications
Streptococcal infectionInfections and infestations
Abdominal pain upperGastrointestinal disorders
Injection site hemorrhageGeneral disorders
Muscle spasmsMusculoskeletal and connective tissue disorders
ToothacheGastrointestinal disorders
BlepharitisEye disorders
Edema peripheralGeneral disorders
ProctalgiaGastrointestinal disorders
Vessel puncture site hematomaGeneral disorders
FatigueGeneral disorders
InsomniaPsychiatric disorders
Amylase increasedInvestigations
Blood pressure systolic increasedInvestigations

Data from ClinicalTrials.gov NCT05285137 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antiviral strategies against influenza virus: an update on approved and innovative therapeutic approaches.
    Bonomini A, Mercorelli B, Loregian A. · · 2025 · cited 24× · PMID 39945883 · DOI 10.1007/s00018-025-05611-1
  2. Drug-Fc conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice.
    Döhrmann S, Levin J, Cole JN, Borchardt A, et al · · 2025 · cited 8× · PMID 40097766 · DOI 10.1038/s41564-025-01955-3
  3. Prophylactic Efficacy of CD388, a Novel Drug-Fc Conjugate, in a Human Influenza A/H3N2 Virus Challenge Model: A Randomized, Controlled Phase 2a Study.
    Rojas RE, Equils O, Villacian J, Mann A, et al · · 2025 · PMID 41060047 · DOI 10.1093/cid/ciaf465
  4. CD388: A universally protective Drug-Fc Conjugate that targets influenza virus neuraminidase
    Döhrmann S, Levin J, Cole JN, Borchardt A, et al · · 2024 · DOI 10.1101/2024.06.04.597465
  5. 2116. Efficacy of CD388, a Novel Drug Fc-Conjugate (DFC), is Driven by the Small Molecule Neuraminidase Inhibitor (NAI)
    · 2023

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Other trials of CD388 Injection

Trials testing the same drug.

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Currently open trials in the same condition.

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Data sources for this page

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