Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04811469 | Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults | PHASE1 | COMPLETED | 74 | — | — | May 24, 2021 | May 21, 2022 | Aug 10, 2022 | 1 | Australia |
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary.
The investigator may use the CTCAE V5.0 to assist in the determination of severity and clinical significance.
Blood pressure measured in mmHg
Pulse rate measured per minute
respiratory rate measured in breaths per minute
tympanic temperature measured in celsius
Physical examinations includes examination in cutaneous, lymph node, head (especially of eyes) and neck, chest, abdomen, musculoskeletal and nervous systems.
Heart rate in beats per minute (Bpm) through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
R-R interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
P-R interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
QRS complex measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
QT interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
QTcF interval measured in millisecond through 12-lead ECG assessment. The Investigator or designee will be responsible for review and interpretation of safety ECGs on site.
Measured in g/dL. The physician will judge whether an abnormality is clinically significant.
Measured in g/dL. The physician will judge whether an abnormality is clinically significant.
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured in U/L. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in %. The physician will judge whether an abnormality is clinically significant.
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Urine Occult Blood will be record as positive or negative. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Urinary leukocyte will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Urine erythrocytes will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
The physician will judge whether an abnormality is clinically significant.
Measured in Units. The physician will judge whether an abnormality is clinically significant.
Measured in Units. The physician will judge whether an abnormality is clinically significant.
Recorded as positive or negative. The physician will judge whether an abnormality is clinically significant.
| Arm | Type | Description |
|---|---|---|
| CBP-174 | EXPERIMENTAL | CBP-174 oral solution |
| Placebo | EXPERIMENTAL | placebo oral solution |
| Name | Type | Description |
|---|---|---|
| CBP-174 | DRUG | CBP-174 oral solution, given once |
| Placebo | DRUG | Placebo oral solution, given once |
Inclusion Criteria: Subjects will be enrolled into the study only if they meet ALL of the following inclusion criteria: 1. Subjects are fully informed of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure 2. Healthy male and female ...