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CBP-174

Phase 1

Undisclosed | Small molecule | Other |Connect Biopharma Holdings Limited|Trials Updated: Aug 10, 2022

CBP-174 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2021

CBP-174 target and mechanism

Molecular targetH3R
Target classReceptor
ModalitySmall molecule

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

CBP-174 clinical trials

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?

CBP-174 is an investigational small molecule drug being developed by Connect Biopharma Holdings Limited. It has completed a Phase 1 clinical trial in healthy adult volunteers. Its therapeutic indications have not been disclosed, so it is not yet associated with a specific disease area in public disclosures.

What does CBP-174 target?

CBP-174 targets the H3 receptor, also known as H3R, a receptor class molecular target. It is a small molecule designed to act on this receptor. Targeting H3R places CBP-174 among compounds that modulate histamine H3 receptor signaling, though its specific clinical application remains undisclosed.

Who makes CBP-174?

CBP-174 is being developed by Connect Biopharma Holdings Limited, which trades under the ticker CNTB. The company is the sponsor of the drug's clinical program. Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory and autoimmune conditions.

What phase is CBP-174 in?

CBP-174 is in Phase 1 development. It has completed one Phase 1 clinical trial and has no active trials at this time. As an investigational drug, CBP-174 has not been approved by the FDA or any other regulatory authority for commercial use.

What clinical trials is CBP-174 in?

CBP-174 has been studied in one completed Phase 1 trial, NCT04811469, titled Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults. The trial enrolled 74 healthy adult volunteers in Australia, was randomized, double-blind, and controlled, and included participants aged 18 years and older.