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CBP-174

Phase 1

Healthy Adult Subjects | Small molecule | Other |Connect Biopharma Holdings Limited|Last Updated: Aug 10, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

CBP-174 · 1 trial · 1 indication

Phase 1 1
NCT04811469Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy AdultsHealthy Adult Subjects
COMPLETED74 Analytics
PHASE1COMPLETED
Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults
Healthy Adult SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events and serious adverse events
Up to 7 days post dosing

Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary.

Severity of adverse events and serious adverse events
Up to 7 days post dosing

The investigator may use the CTCAE V5.0 to assist in the determination of severity and clinical significance.

Change in blood pressure
Up to 7 days post dosing

Blood pressure measured in mmHg

Change in pulse rate
Up to 7 days post dosing

Pulse rate measured per minute

Change in respiratory rate
Up to 7 days post dosing

respiratory rate measured in breaths per minute

Change in tympanic temperature
Up to 7 days post dosing

tympanic temperature measured in celsius

Clinically significant abnormality in physical examinations
Up to 7 days post dosing

Physical examinations includes examination in cutaneous, lymph node, head (especially of eyes) and neck, chest, abdomen, musculoskeletal and nervous systems.

Clinically significant change in heart rate
Up to 7 days post dosing

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.

Clinically significant change in RR interval
Up to 7 days post dosing

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.

Clinically significant change in PR interval
Up to 7 days post dosing

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.

Clinically significant change in QRS complex
Up to 7 days post dosing

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.

Clinically significant change in QT interval
Up to 7 days post dosing

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.

Clinically significant change in Fridericia's Correction QT (QTcF) interval
Up to 7 days post dosing

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.

Clinically significant abnormal laboratory value in Total Protein (TB)
Up to 7 days post dosing

Measured in g/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Albumin (ALB)
Up to 7 days post dosing

Measured in g/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Alanine aminotransferase (ALT)
Up to 7 days post dosing

Measured in IU/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Aspartate aminotransferase (AST)
Up to 7 days post dosing

Measured in IU/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Alkaline phosphatase (ALP/AKP)
Up to 7 days post dosing

Measured in IU/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Glutamyl transpeptidase
Up to 7 days post dosing

Measured in U/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Total bilirubin
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Direct Bilirubin
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Indirect Bilirubin
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Glucose
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Urea
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Uric Acid
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Creatinine
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Creatine Kinase
Up to 7 days post dosing

Measured in IU/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Potassium
Up to 7 days post dosing

Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Sodium
Up to 7 days post dosing

Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Chloride
Up to 7 days post dosing

Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Calcium
Up to 7 days post dosing

Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Total Cholesterol
Up to 7 days post dosing

Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal laboratory value in Blood Triglycerides
Up to 7 days post dosing

Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Leukocyte Count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Neutrophil count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Lymphocyte count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Monocytes count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Eosinophils count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Basophil count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in percentage of Neutrophil
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in percentage of Lymphocyte
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in percentage of Monocytes
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in percentage of Eosinophils
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in percentage of Basophils
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Erythrocyte count
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Hemoglobin
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Hematocrit
Up to 7 days post dosing

Measured in %. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Platelets
Up to 7 days post dosing

Counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal finding in Urine Occult Blood
Up to 7 days post dosing

Urine Occult Blood will be record as positive or negative. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine Bilirubin
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine pH
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine Protein
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine Glucose
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine Specific gravity
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine Ketones
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urobilinogen
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urinary leukocyte
Up to 7 days post dosing

Urinary leukocyte will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine erythrocytes
Up to 7 days post dosing

Urine erythrocytes will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Urine Nitrites
Up to 7 days post dosing

Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Prothrombin time (PT)
Up to 7 days post dosing

Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Activated partial thromboplastin time (APTT)
Up to 7 days post dosing

Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in International normalized ratio (INR)
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Fibrinogen (FIB)
Up to 7 days post dosing

Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal change in Thrombin time (TT)
Up to 7 days post dosing

Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal in Feces colour
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal in Feces properties
Up to 7 days post dosing

The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal in Fecal Red blood cell
Up to 7 days post dosing

Measured in Units. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal in Fecal White blood cell
Up to 7 days post dosing

Measured in Units. The physician will judge whether an abnormality is clinically significant.

Clinically significant abnormal in Fecal Occult blood
Up to 7 days post dosing

Recorded as positive or negative. The physician will judge whether an abnormality is clinically significant.

Secondary Endpoints

AUC0-72 h: Area under the plasma concentration-time curve of CBP-174 from time 0 to 72h
Up to 72 hours post dosing
AUC0-∞: Area under the plasma concentration-time curve of CBP-174 from time 0 to infinity
Up to 72 hours post dosing
Cmax: Maximum observed concentration
Up to 72 hours post dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CBP-174EXPERIMENTALCBP-174 oral solution
PlaceboEXPERIMENTALplacebo oral solution

Interventions

NameTypeDescription
CBP-174DRUGCBP-174 oral solution, given once
PlaceboDRUGPlacebo oral solution, given once
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Australia
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Frequently asked questions about CBP-174

What is CBP-174 used for?

CBP-174 is an investigational small molecule being studied in healthy adult subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics. The drug is not approved and remains under investigation.

Who makes CBP-174?

CBP-174 is being developed by Connect Biopharma Holdings Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNTB. The company is conducting clinical research on this investigational small molecule.

What phase is CBP-174 in?

CBP-174 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.

What clinical trials is CBP-174 in?

CBP-174 has one completed Phase 1 clinical trial, identified as NCT04811469, titled "Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults." The study enrolled 74 participants in Australia and was a randomized, double-blind, controlled trial.

Is CBP-174 FDA approved?

CBP-174 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on healthy adult subjects to assess safety, tolerability, and pharmacokinetics, but the drug has not received regulatory approval.