Healthy Adult SubjectsPhase 1NCT04811469
Safety, Tolerability and Pharmacokinetics of CBP-174 in Healthy Adults
A Phase 1 study testing CBP-174 in people with Healthy Adult Subjects, run by Connect Biopharma Australia Pty Ltd at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of CBP-174 after a single oral dose in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- CBP-174
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteAustralia
- Study dates
- 24 May 2021to 21 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be enrolled into the study only if they meet ALL of the following inclusion criteria:
- 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
- Healthy male and female subjects, aged 18 to 55 years (both inclusive)
- Body mass index is between 18 and 32 kg/m2 (both inclusive), the weight of male subjects ≥ 50 kg, the weight of female subjects ≥ 45 kg
- Considered generally normal or abnormal with no clinical significance upon medical history, physical examination, vital signs, ECG, and clinical laboratory tests, as judged by the Investigator
- Female subjects of child-bearing potential must agree to use highly effective contraceptive methods 1 month before the screening, during the entire study, and within 3 months after the end of this study, and have no egg donation plan within 3 months of study end. The male partner of a female subject must agree to use condoms during the screening, entire study, and within 3 months after the end of this study. Male subjects considered fertile must agree to not plan to father a child, donate sperm, and take effective contraceptive methods during the screening, entire study, and within 3 months after the end of this study. The female partner of male subjects must agree to use a highly effective method of female contraception (Section 9.8.3.2) during the screening, entire study, and within 3 months after the end of this study. Contraceptive requirements applies to subjects in same sex relationships for male and female subjects, female subjects of non child bearing potential or male subjects with female partners of non-childbearing potential.
- Subjects who are able to communicate well with Investigators, as well as understand and adhere to the requirements of this study
Who cannot join
- Subjects will be excluded from the study, if they meet ANY of the following criteria:
- Subjects will be excluded from the study, if they meet ANY of the following criteria:
- Subjects who have difficulties in venous blood collection or history of dizziness with blood or needles
- Female subjects who have a positive pregnancy test or are breastfeeding
- Subjects who have allergy/hypersensitivity history to any excipient of CBP-174 solution, or hypersensitivity to antihistamines, or severe allergies at the discretion of Investigator
- Exposure to any other investigational medicinal product or any other clinical trial within 30 days or 5 times half-lives (whichever is longer) before dosing current study medication
Show all 29Show fewer
- Subjects who have a history of gastrointestinal (such as duodenal ulcer, alimentary tract hemorrhage, etc.), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- Subjects who have a history of significant eye diseases (such as keratitis, and scleritis, etc.) or clinical significant eye signs (conjunctiva hyperemia, etc.)
- Subjects who have a history of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
- Subjects who have a history of sleep disorders within 2 years before the screening visit or score highly on the PSQI or ISI questionaire; or have a history of epilepsy or other seizure disorder
- Pittsburgh Sleep Quality Index (PSQI) ≥ 8 or Insomnia Severity Index (ISI) ≥ 8
- Subjects who have the medical history of other significant diseases (including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological endocrinological, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases) or any other disease/ailment at the discretion of the Investigator
- Subjects with any of the following clinical laboratory tests results at screening:
- a Aspartate aminotransferase (AST) > 1.5 × the upper limit of normal (ULN)
- b Alanine aminotransferase (ALT) > 1.5 × ULN
- c Serum creatinine > 1.2 × ULN; or creatinine clearance < 60 mL/min (calculated by the Cockcroft-Gault)
- The clinical laboratory tests of hematology, blood biochemistry, or urinalysis could be allowed repeat once if Investigator considers it necessary
- Subjects whose QTcF interval prolongation at screening (male: QTcF interval ≥ 450 ms, female: QTcF interval ≥ 470 ms)
- Blood donation or blood loss more than 400 mL within 3 months before the screening visit
- Subjects with a known history of drug abuse within 2 years before the screening visit; or positive drug abuse at screening
- Weekly alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of spirit with the alcohol content of 40% or 150 mL of wine) in any week within the past 3 months before the screening visit; or intake of alcohol-containing products within 48 hours before the first dose, or cannot abstain from any alcohol product during the study, or positive breath alcohol test at screening or check-in (Day -1）
- Smoking history (> 5 cigarettes per day) within 3 months before the screening visit, or cannot abstain from any tobacco products during the study, or positive urine nicotine test before randomization
- Excessive drinking of tea, coffee, or caffeine-containing beverage (at least 8 cups per day, 1 cup = 250 mL) any day within 3 months before screening; intake of rich caffeine- or xanthine-containing food or drinks that may produce caffeine or xanthine after being metabolized (eg, coffee, tea, chocolate, cola drinks) within 48 hours before the first dose
- Any marketed medication (prescription and nonprescription drugs) within 14 days before the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication (excluding oral contraceptives and low dose paracetamol at the discretion of the Investigator, or topical ointments at the discretion of the Investigator)
- Administration of a Coronavirus Disease 2019 (COVID-19) vaccine in the past 14 days prior to dosing
- Use of herbal medicines, dietary supplements and vitamin within 14 days before the first dose(permissible at the discretion of the Investigator)
- Subjects who have a major surgery within 3 months before the first dose or who plan to undergo surgery during the study
- Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody
- Subjects who are determined as not eligible to participate in this study by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-174 After Oral Administration
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of CBP-174 after a single oral dose in healthy adult subjects.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of CBP-174 compared to placebo. The study plans to set 6 dose escalation cohorts with single oral dose. Each subject will receive only one dose regimen in this study and the total duration to participate the study is approximately 1 to 4-week.
- Conditions
- Healthy Adult Subjects
- Being tested
- CBP-174, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBP-174Drug
CBP-174 oral solution, given once
PlaceboDrug
Placebo oral solution, given once
| Study group | Role | What they receive |
|---|---|---|
| CBP-174 | Experimental | CBP-174 oral solution Receives: Drug: CBP-174 |
| Placebo | Experimental | placebo oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events
Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary.
Measured: Up to 7 days post dosing
Severity of adverse events and serious adverse events
The investigator may use the CTCAE V5.0 to assist in the determination of severity and clinical significance.
Measured: Up to 7 days post dosing
Change in blood pressure
Blood pressure measured in mmHg
Measured: Up to 7 days post dosing
Change in pulse rate
Pulse rate measured per minute
Measured: Up to 7 days post dosing
Change in respiratory rate
respiratory rate measured in breaths per minute
Measured: Up to 7 days post dosing
Change in tympanic temperature
tympanic temperature measured in celsius
Measured: Up to 7 days post dosing
Clinically significant abnormality in physical examinations
Physical examinations includes examination in cutaneous, lymph node, head (especially of eyes) and neck, chest, abdomen, musculoskeletal and nervous systems.
Measured: Up to 7 days post dosing
Clinically significant change in heart rate
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.
Measured: Up to 7 days post dosing
Clinically significant change in RR interval
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.
Measured: Up to 7 days post dosing
Clinically significant change in PR interval
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.
Measured: Up to 7 days post dosing
Clinically significant change in QRS complex
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.
Measured: Up to 7 days post dosing
Clinically significant change in QT interval
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.
Measured: Up to 7 days post dosing
Clinically significant change in Fridericia's Correction QT (QTcF) interval
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: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Total Protein (TB)
Measured in g/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Albumin (ALB)
Measured in g/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Alanine aminotransferase (ALT)
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Aspartate aminotransferase (AST)
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Alkaline phosphatase (ALP/AKP)
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Glutamyl transpeptidase
Measured in U/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Total bilirubin
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Direct Bilirubin
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Indirect Bilirubin
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Glucose
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Urea
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Uric Acid
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Creatinine
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Creatine Kinase
Measured in IU/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Potassium
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Sodium
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Chloride
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Calcium
Measured in mmol/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Total Cholesterol
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal laboratory value in Blood Triglycerides
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Leukocyte Count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Neutrophil count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Lymphocyte count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Monocytes count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Eosinophils count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Basophil count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in percentage of Neutrophil
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in percentage of Lymphocyte
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in percentage of Monocytes
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in percentage of Eosinophils
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in percentage of Basophils
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Erythrocyte count
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Hemoglobin
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Hematocrit
Measured in %. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Platelets
Counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal finding in Urine Occult Blood
Urine Occult Blood will be record as positive or negative. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine Bilirubin
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine pH
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine Protein
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine Glucose
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine Specific gravity
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine Ketones
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urobilinogen
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urinary leukocyte
Urinary leukocyte will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine erythrocytes
Urine erythrocytes will be counted in K/uL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Urine Nitrites
Measured in mg/dL. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Prothrombin time (PT)
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Activated partial thromboplastin time (APTT)
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in International normalized ratio (INR)
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Fibrinogen (FIB)
Measured in mmol/L. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal change in Thrombin time (TT)
Measured in seconds by coagulation tests. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal in Feces colour
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal in Feces properties
The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal in Fecal Red blood cell
Measured in Units. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal in Fecal White blood cell
Measured in Units. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Clinically significant abnormal in Fecal Occult blood
Recorded as positive or negative. The physician will judge whether an abnormality is clinically significant.
Measured: Up to 7 days post dosing
Secondary outcomes (9)
AUC0-72 h: Area under the plasma concentration-time curve of CBP-174 from time 0 to 72h
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
AUC0-∞: Area under the plasma concentration-time curve of CBP-174 from time 0 to infinity
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
Cmax: Maximum observed concentration
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
Tmax: Time to maximum concentration;
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
T1/2: Elimination half-life;
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
λz: Terminal phase rate constant;
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
CL/F: Apparent clearance;
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
V/F: Apparent Volume;
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
%AUCex: Percentage of AUC0-∞ obtained by extrapolation
Calculated by non-compartmental analysis with WinNonlin (Version 8.3.1 or above)
Measured: Up to 72 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start24 May 2021
- Primary completion14 May 2022
- Study completion21 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connect Biopharma Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Australia Connect, Study director, Connect Biopharma Australia Pty LtdSuzhou Connect, Study director, Connect Biopharm LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811469
- Sponsor's protocol ID
- CBP-174AU001
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of CBP-174 After Oral Administration
- ClinicalTrials.gov ID
- NCT04811469
- Acronym / sponsor ID
- CBP-174AU001
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Connect Biopharma Australia Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 14 May 2022 (actual)
- Study completion
- 21 May 2022 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of CBP-174 after a single oral dose in healthy adult subjects.
Detailed description
This is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of CBP-174 compared to placebo. The study plans to set 6 dose escalation cohorts with single oral dose. Each subject will receive only one dose regimen in this study and the total duration to participate the study is approximately 1 to 4-week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBP-174 | Experimental | Drug: CBP-174CBP-174 oral solution |
| Placebo | Experimental | Drug: Placeboplacebo oral solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects will be enrolled into the study only if they meet ALL of the following inclusion criteria:
- 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
- Healthy male and female subjects, aged 18 to 55 years (both inclusive)
- Body mass index is between 18 and 32 kg/m2 (both inclusive), the weight of male subjects ≥ 50 kg, the weight of female subjects ≥ 45 kg
- Considered generally normal or abnormal with no clinical significance upon medical history, physical examination, vital signs, ECG, and clinical laboratory tests, as judged by the Investigator
Key exclusion criteria (29 listed)
- Subjects who have difficulties in venous blood collection or history of dizziness with blood or needles
- Female subjects who have a positive pregnancy test or are breastfeeding
- Subjects who have allergy/hypersensitivity history to any excipient of CBP-174 solution, or hypersensitivity to antihistamines, or severe allergies at the discretion of Investigator
- Exposure to any other investigational medicinal product or any other clinical trial within 30 days or 5 times half-lives (whichever is longer) before dosing current study medication
- Subjects who have a history of gastrointestinal (such as duodenal ulcer, alimentary tract hemorrhage, etc.), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBP-174CBP-174 oral solution, given once | Drug | CBP-174 |
| PlaceboPlacebo oral solution, given once | Drug | Placebo |
Primary outcome
Incidence of adverse events and serious adverse events
Time frame: 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
Time frame: 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
Time frame: Up to 7 days post dosing
Blood pressure measured in mmHg
Change in pulse rate
Time frame: Up to 7 days post dosing
Pulse rate measured per minute
Change in respiratory rate
Time frame: Up to 7 days post dosing
respiratory rate measured in breaths per minute
Change in tympanic temperature
Time frame: Up to 7 days post dosing
tympanic temperature measured in celsius
Clinically significant abnormality in physical examinations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in percentage of Lymphocyte
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in percentage of Monocytes
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in percentage of Eosinophils
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in percentage of Basophils
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in Erythrocyte count
Time frame: 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
Time frame: 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
Time frame: Up to 7 days post dosing
Measured in %. The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in Platelets
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in Urine Protein
Time frame: 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
Time frame: 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
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in Urine Ketones
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal change in Fibrinogen (FIB)
Time frame: 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)
Time frame: 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
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal in Feces properties
Time frame: Up to 7 days post dosing
The physician will judge whether an abnormality is clinically significant.
Clinically significant abnormal in Fecal Red blood cell
Time frame: 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
Time frame: 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
Time frame: Up to 7 days post dosing
Recorded as positive or negative. The physician will judge whether an abnormality is clinically significant.
9 secondary outcomes
AUC0-72 h: Area under the plasma concentration-time curve of CBP-174 from time 0 to 72h
Time frame: Up to 72 hours post dosing
AUC0-∞: Area under the plasma concentration-time curve of CBP-174 from time 0 to infinity
Time frame: Up to 72 hours post dosing
Cmax: Maximum observed concentration
Time frame: Up to 72 hours post dosing
Tmax: Time to maximum concentration;
Time frame: Up to 72 hours post dosing
T1/2: Elimination half-life;
Time frame: Up to 72 hours post dosing
λz: Terminal phase rate constant;
Time frame: Up to 72 hours post dosing
CL/F: Apparent clearance;
Time frame: Up to 72 hours post dosing
V/F: Apparent Volume;
Time frame: Up to 72 hours post dosing
%AUCex: Percentage of AUC0-∞ obtained by extrapolation
Time frame: Up to 72 hours post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Australia Connect study director
Connect Biopharma Australia Pty Ltd
Suzhou Connect study director
Connect Biopharm LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBP-174 in people with Healthy Adult Subjects, run by Connect Biopharma Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events (time frame: Up to 7 days post dosing). The study lists 69 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.