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 CD388Primary· 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
Group
Value
95% CI
CD388 50 mg IM
5
CD388 150 mg IM
5
CD388 450 mg IM
5
Pooled Placebo IM
8
CD388 50 mg SQ
5
CD388 150 mg SQ
4
CD388 450 mg SQ
5
CD388 900 mg SQ
3
Pooled Placebo SQ
7
Participants with AEs leading to study withdrawal
Group
Value
95% CI
CD388 50 mg IM
0
CD388 150 mg IM
0
CD388 450 mg IM
0
Pooled Placebo IM
0
CD388 50 mg SQ
0
CD388 150 mg SQ
0
CD388 450 mg SQ
2
CD388 900 mg SQ
0
Pooled Placebo SQ
0
Severity of TEAEs After a Single Dose of CD388Primary· 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
Group
Value
95% CI
CD388 50 mg IM
5
CD388 150 mg IM
5
CD388 450 mg IM
2
Pooled Placebo IM
5
CD388 50 mg SQ
4
CD388 150 mg SQ
4
CD388 450 mg SQ
3
CD388 900 mg SQ
3
Pooled Placebo SQ
6
Moderate
Group
Value
95% CI
CD388 50 mg IM
0
CD388 150 mg IM
0
CD388 450 mg IM
3
Pooled Placebo IM
2
CD388 50 mg SQ
1
CD388 150 mg SQ
0
CD388 450 mg SQ
1
CD388 900 mg SQ
0
Pooled Placebo SQ
1
Severe
Group
Value
95% CI
CD388 50 mg IM
0
CD388 150 mg IM
0
CD388 450 mg IM
0
Pooled Placebo IM
1
CD388 50 mg SQ
0
CD388 150 mg SQ
0
CD388 450 mg SQ
1
CD388 900 mg SQ
0
Pooled Placebo SQ
0
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
4.13
± 0.747
Cohort 2A CD388 150 mg IM
10.4
± 2.44
Cohort 3A CD388 450 mg IM
48.6
± 11.7
Cohort 1B CD388 50 mg SQ
3.57
± 0.942
Cohort 2B CD388 150 mg SQ
12.0
± 3.35
Cohort 3B CD388 450 mg SQ
32.7
± 9.40
Cohort 4B CD388 900 mg SQ
58.8
± 17.5
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
3.96
2.91 – 5.34
Cohort 2A CD388 150 mg IM
10.4
6.52 – 13.6
Cohort 3A CD388 450 mg IM
48.0
35.2 – 67.7
Cohort 1B CD388 50 mg SQ
3.72
2.17 – 4.83
Cohort 2B CD388 150 mg SQ
11.8
6.84 – 17.0
Cohort 3B CD388 450 mg SQ
31.6
16.6 – 48.0
Cohort 4B CD388 900 mg SQ
60.7
34.3 – 91.3
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
111.08
± 72.42
Cohort 2A CD388 150 mg IM
159.03
± 83.10
Cohort 3A CD388 450 mg IM
85.64
± 42.19
Cohort 1B CD388 50 mg SQ
213.00
± 108.43
Cohort 2B CD388 150 mg SQ
137.48
± 77.82
Cohort 3B CD388 450 mg SQ
120.04
± 67.83
Cohort 4B CD388 900 mg SQ
109.54
± 55.66
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
96.07
48.17 – 240.00
Cohort 2A CD388 150 mg IM
131.98
71.97 – 312.00
Cohort 3A CD388 450 mg IM
78.31
24.17 – 144.00
Cohort 1B CD388 50 mg SQ
228.00
72.00 – 312.02
Cohort 2B CD388 150 mg SQ
131.28
48.22 – 312.02
Cohort 3B CD388 450 mg SQ
96.00
48.17 – 240.00
Cohort 4B CD388 900 mg SQ
96.00
48.17 – 192.00
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
1234.41
± 140.04
Cohort 2A CD388 150 mg IM
1192.03
± 235.80
Cohort 3A CD388 450 mg IM
1006.20
± 314.39
Cohort 1B CD388 50 mg SQ
1069.78
± 216.48
Cohort 2B CD388 150 mg SQ
1265.53
± 223.93
Cohort 3B CD388 450 mg SQ
1065.21
± 239.19
Cohort 4B CD388 900 mg SQ
1384.36
± 282.53
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
1275.62
985.09 – 1390.45
Cohort 2A CD388 150 mg IM
1285.85
783.24 – 1471.71
Cohort 3A CD388 450 mg IM
1137.42
540.88 – 1384.09
Cohort 1B CD388 50 mg SQ
1052.39
685.81 – 1350.50
Cohort 2B CD388 150 mg SQ
1270.40
796.65 – 1576.21
Cohort 3B CD388 450 mg SQ
1040.30
809.64 – 1502.38
Cohort 4B CD388 900 mg SQ
1287.45
1110.87 – 1998.04
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
0.00751
± 0.00119
Cohort 2A CD388 150 mg IM
0.00867
± 0.00177
Cohort 3A CD388 450 mg IM
0.00766
± 0.00199
Cohort 1B CD388 50 mg SQ
0.00900
± 0.00230
Cohort 2B CD388 150 mg SQ
0.00725
± 0.00123
Cohort 3B CD388 450 mg SQ
0.00883
± 0.00213
Cohort 4B CD388 900 mg SQ
0.00863
± 0.00158
Median Apparent Clearance (CL/F) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
0.00707
0.00614 – 0.00991
Cohort 2A CD388 150 mg IM
0.00851
0.00640 – 0.0112
Cohort 3A CD388 450 mg IM
0.00726
0.00571 – 0.0116
Cohort 1B CD388 50 mg SQ
0.00834
0.00591 – 0.0128
Cohort 2B CD388 150 mg SQ
0.00717
0.00551 – 0.00909
Cohort 3B CD388 450 mg SQ
0.00912
0.00493 – 0.0115
Cohort 4B CD388 900 mg SQ
0.00870
0.00648 – 0.0111
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
13.3
± 1.91
Cohort 2A CD388 150 mg IM
14.8
± 4.40
Cohort 3A CD388 450 mg IM
10.7
± 2.99
Cohort 1B CD388 50 mg SQ
13.4
± 2.59
Cohort 2B CD388 150 mg SQ
13.3
± 3.70
Cohort 3B CD388 450 mg SQ
13.1
± 2.61
Cohort 4B CD388 900 mg SQ
17.1
± 3.76
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388Secondary· 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.
Group
Value
95% CI
Cohort 1A CD388 50 mg IM
13.9
10.3 – 15.8
Cohort 2A CD388 150 mg IM
14.4
11.1 – 23.9
Cohort 3A CD388 450 mg IM
10.9
6.47 – 15.1
Cohort 1B CD388 50 mg SQ
12.2
11.4 – 18.7
Cohort 2B CD388 150 mg SQ
12.7
9.27 – 20.7
Cohort 3B CD388 450 mg SQ
12.9
10.7 – 18.9
Cohort 4B CD388 900 mg SQ
16.7
11.2 – 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.
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):
NCT06609460 — Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
· Phase 2
· completed
NCT05619536 — Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects
· Phase 1
· completed
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Other Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials
Trials by the same sponsor.
NCT06609460 — Study of CD388 for the Prevention of Influenza in Subjects Not at Risk for Influenza Complications
· Phase 2
· completed
NCT05619536 — Study of CD388 Subcutaneous Administration in Healthy Japanese Subjects
· Phase 1
· completed
NCT05523089 — The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
· Phase 2
· completed
NCT03667690 — Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
· Phase 3
· completed
NCT02888197 — Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 27 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05285137.