Adults 20 to 55, any sex, with COVID-19. 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 (TEAT)Primary· Day 1 to Day 5
Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity \[as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0\], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.
Group
Value
95% CI
CX-4945 200mg QD
1
CX-4945 200mg BID
3
CX-4945 400mg BID
7
Evaluate Changes in Blood Chemistry.Secondary· Day 1 to Day 6
Changes ALP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Group
Value
95% CI
CX-4945 200mg QD
-2.1
± 5.78
CX-4945 200mg BID
-0.3
± 6.62
CX-4945 400mg BID
3.4
± 2.84
Evaluate Changes in Blood Chemistry.Secondary· Day 1 to Day 6
Changes AST in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Group
Value
95% CI
CX-4945 200mg QD
-3.9
± 5.11
CX-4945 200mg BID
-2.4
± 3.72
CX-4945 400mg BID
0.1
± 3.35
To Evaluate Changes in Blood Chemistry.Secondary· Day 1 to Day 6
Changes ALT in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Group
Value
95% CI
CX-4945 200mg QD
-4.0
± 6.15
CX-4945 200mg BID
-1.4
± 5.19
CX-4945 400mg BID
0.9
± 4.77
To Evaluate Changes in Blood Chemistry.Secondary· Day 1 to Day 6
Changes LDH in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Group
Value
95% CI
CX-4945 200mg QD
-17.0
± 17.17
CX-4945 200mg BID
-26.2
± 10.75
CX-4945 400mg BID
-28.2
± 14.33
To Evaluate Changes in Blood Chemistry.Secondary· Day 1 to Day 6
Changes CPK in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Group
Value
95% CI
CX-4945 200mg QD
-24.3
± 19.35
CX-4945 200mg BID
-54.0
± 63.71
CX-4945 400mg BID
-65.1
± 71.37
To Evaluate Changes in Blood Chemistry.Secondary· Day 1 to Day 6
Changes CRP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Group
Value
95% CI
CX-4945 200mg QD
0.003
± 0.1341
CX-4945 200mg BID
-0.071
± 0.2497
CX-4945 400mg BID
0.002
± 0.0447
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECGSecondary· Screening, Day 1, Day 3, Day 5, and Day 6
ECG assessments were done during Screening, Day 1, Day 3, Day 5, and Day 6. A 12-lead ECG was performed at baseline (Day1), Day 3, Day 5, and Day 6 and categorized as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS).
Screening
Group
Value
95% CI
CX-4945 200mg QD
7
CX-4945 200mg BID
6
CX-4945 400mg BID
6
Day 1 (Baseline)
Group
Value
95% CI
CX-4945 200mg QD
3
CX-4945 200mg BID
4
CX-4945 400mg BID
8
Day 3
Group
Value
95% CI
CX-4945 200mg QD
7
CX-4945 200mg BID
9
CX-4945 400mg BID
6
Day 5
Group
Value
95% CI
CX-4945 200mg QD
5
CX-4945 200mg BID
6
CX-4945 400mg BID
7
Day 6
Group
Value
95% CI
CX-4945 200mg QD
6
CX-4945 200mg BID
6
CX-4945 400mg BID
6
Adverse events — posted to ClinicalTrials.gov
Time frame: from Day 1 to Day 6.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03897036 — Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)
· Phase 1
· completed
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Other Senhwa Biosciences, Inc. trials
Trials by the same sponsor.
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· Phase 2
· terminated
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· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Senhwa Biosciences, Inc.
Last refreshed: 27 January 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/NCT05817708.