NCT05619536

Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects

Completed Phase 1 Results posted Last updated 1 October 2024

What this trial tests

Phase 1 trial testing CD388 Injection in Healthy in 28 participants. Completed in 14 July 2023.

Timeline

18 October 2022

Primary endpoint
14 July 2023

14 July 2023

Quick facts

Lead sponsor	Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	28
Start date	18 October 2022
Primary completion	14 July 2023
Estimated completion	14 July 2023
Sites	1 location across United States

Drugs / interventions tested

• CD388 Injection
• Saline placebo

Conditions studied

• Healthy — all drugs for Healthy →

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

Group	Value	95% CI
50 mg CD388	7
150 mg CD388	3
450 mg CD388	6
Pooled Placebo	2

Severity of Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388 Primary · 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.

Grade 1 (Mild)

Group	Value	95% CI
50 mg CD388	7
150 mg CD388	3
450 mg CD388	6
Pooled Placebo	2

Grade 2 (Moderate)

Group	Value	95% CI
50 mg CD388	0
150 mg CD388	0
450 mg CD388	0
Pooled Placebo	0

Grade 3 (Severe)

Group	Value	95% CI
50 mg CD388	0
150 mg CD388	0
450 mg CD388	0
Pooled Placebo	0

Maximum Plasma Concentration (Cmax) Following CD388 Injection Administration Secondary · 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)

Evaluation of the maximum plasma concentration (Cmax) following subcutaneous administration of a single dose of CD388.

Group	Value	95% CI
Cohort 1	3.87	± 0.776
Cohort 2	13.5	± 4.10
Cohort 3	41.7	± 9.27

Time to Maximum Plasma Concentration (Tmax) Following CD388 Injection Administration Secondary · 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)

Evaluation of the time to maximum plasma concentration (Tmax) following subcutaneous administration of a single dose of CD388.

Group	Value	95% CI
Cohort 1	312.00	192.00 – 313.03
Cohort 2	97.00	48.00 – 313.00
Cohort 3	144.00	72.00 – 312.02

Terminal Elimination Half-life (t½) Following CD388 Injection Administration Secondary · 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)

Evaluation of the terminal elimination half-life (t½) following subcutaneous administration of a single dose of CD388.

Group	Value	95% CI
Cohort 1	1325.86	± 289.24
Cohort 2	1284.26	± 389.61
Cohort 3	1210.10	± 193.31

Apparent Clearance (CL/F) Following CD388 Injection Administration Secondary · 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)

Evaluation of the apparent clearance (CL/F) following subcutaneous administration of a single dose of CD388.

Group	Value	95% CI
Cohort 1	0.00653	± 0.000529
Cohort 2	0.00723	± 0.00200
Cohort 3	0.00764	± 0.00144

Apparent Volume of Distribution (VZ/F) Following CD388 Injection Administration Secondary · 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)

Evaluation of the apparent volume of distribution (VZ/F) following subcutaneous administration of a single dose of CD388.

Group	Value	95% CI
Cohort 1	12.5	± 2.87
Cohort 2	12.6	± 3.42
Cohort 3	13.3	± 3.10

Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-last]) Following CD388 Injection Administration Secondary · 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)

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.

Group	Value	95% CI
Cohort 1	5880	± 615
Cohort 2	18900	± 5730
Cohort 3	53300	± 8320

Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following CD388 Injection Administration Secondary · 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)

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.

Group	Value	95% CI
Cohort 1	7700	± 657
Cohort 2	22200	± 6390
Cohort 3	60600	± 10700

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; Day 165 for all others).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

50 mg CD388

Serious: 0/7 (0%)

Deaths: 0/7

150 mg CD388

Serious: 0/8 (0%)

Deaths: 0/8

450 mg CD388

Serious: 0/7 (0%)

Deaths: 0/7

Pooled Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (10 terms — click to expand)

Reaction	System	50 mg CD388	150 mg CD388	450 mg CD388	Pooled Placebo
Fatigue	General disorders	—	—	—	—
Injection site hemorrhage	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Influenza like illness	General disorders	—	—	—	—
Injection site erythema	General disorders	—	—	—	—
Asymptomatic COVID-19	Infections and infestations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT05619536 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

1. 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
2. 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