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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04685564
Registration number
NCT04685564
Ethics application status
Date submitted
8/12/2020
Date registered
28/12/2020
Date last updated
26/04/2022
Titles & IDs
Public title
A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Single Dose-escalation, Phase Ia Clinical Study to Evaluate the Safety and Pharmacokinetics of RBD1016 in Healthy Subjects
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Secondary ID [1]
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RBHB1101-A
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RBD1016
Treatment: Drugs - Placebo
Experimental: RBD1016 experiment group - Subjects in experiment groups will receive a single subcutaneous injection of RBD1016.
Placebo Comparator: placebo gruop - Subjects in placebo groups will receive a single subcutaneous injection of placebo.
Treatment: Drugs: RBD1016
"Sentinel cohort" design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission.
Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission.
Treatment: Drugs: Placebo
the same as RBD1016
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the safety assessment, AE and SAE of ascending single dose of RBD1016 in healthy subjects.
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Assessment method [1]
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Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed by CTCAE v5.0.
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Timepoint [1]
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up to Day 29
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Primary outcome [2]
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To evaluate the safety assessment, 12-lead ECG of ascending single dose of RBD1016 in healthy subjects.
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Assessment method [2]
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The corrected QT (QTcB) value(ms) from baseline will be reviewed by 12-lead electrocardiogram (12-lead ECG).Data from 12-lead ECG will be summarized descriptively by visit, and flagged abnormalities will be listed.
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Timepoint [2]
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up to Day 29
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Primary outcome [3]
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To evaluate the safety assessment, vital signs of ascending single dose of RBD1016 in healthy subjects.
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Assessment method [3]
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Vital signs includes systolic blood pressure(mm Hg), diastolic blood pressure(mm Hg), pulse rate(beats per minute), body temperature(?), respiration(beats per minute).Data from vital signs will be summarized descriptively by visit, and flagged abnormalities will be listed.
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Timepoint [3]
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up to Day 29
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Primary outcome [4]
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To evaluate the safety assessment, physical examinations of ascending single dose of RBD1016 in healthy subjects.
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Assessment method [4]
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Physical examinations include weight(kg) and height(m), skin and mucosa, lymph nodes, head and neck, chest, abdomen, spine and limbs, musculoskeletal system, and nervous system. Weight and height will be combined to report BMI in kg/m^2 and other examination results of each area shall be recorded as normal or abnormal. Any abnormalities should be explained in detail, and persistent abnormalities should be recorded at each visit.
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Timepoint [4]
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up to Day 29
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Primary outcome [5]
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To evaluate the safety assessment, clinical lab examinations of ascending single dose of RBD1016 in healthy subjects.
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Assessment method [5]
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Clinical lab examinations, including hematology, urinalysis, biochemistry and coagulation tests.Clinical lab examinations' data in each group will be summarized by listing the categorical changes and summary statistics of source data as well as the change from baseline at each visit (mean, median, standard deviation, range).
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Timepoint [5]
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up to Day 29
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Secondary outcome [1]
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To characterize the pharmacokinetic parameter Cmax of RBD1016 in healthy subjects.
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Assessment method [1]
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Maximum concentration (Cmax)
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Timepoint [1]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Secondary outcome [2]
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To characterize the pharmacokinetic parameter AUC0-t of RBD1016 in healthy subjects.
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Assessment method [2]
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Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
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Timepoint [2]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Secondary outcome [3]
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To characterize the pharmacokinetic paramete AUC0-inf of RBD1016 in healthy subjects.
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Assessment method [3]
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Area under the concentration-time curve from 0 to infinity (inf) (AUC0-inf)
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Timepoint [3]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Secondary outcome [4]
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To characterize the pharmacokinetic paramete Tmax of RBD1016 in healthy subjects.
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Assessment method [4]
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Time to maximum concentration (Tmax)
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Timepoint [4]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Secondary outcome [5]
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To characterize the pharmacokinetic paramete t1/2 of RBD1016 in healthy subjects.
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Assessment method [5]
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Plasma Half-Life (t1/2)
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Timepoint [5]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Secondary outcome [6]
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To characterize the pharmacokinetic paramete Vz/F of RBD1016 in healthy subjects.
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Assessment method [6]
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Volume of distribution in the terminal elimination period (Vz/F)
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Timepoint [6]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Secondary outcome [7]
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To characterize the pharmacokinetic paramete ?z of RBD1016 in healthy subjects.
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Assessment method [7]
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Terminal rate constant (?z)
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Timepoint [7]
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within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 hours after dosing
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Eligibility
Key inclusion criteria
1. Subjects who voluntarily participate in this clinical trial, are able to correctly
understand and have signed the informed consent in writing;
2. Male or female volunteers aged between 18 and 45 years (inclusive);
3. Body weight: male = 50 kg, female = 45 kg; Body Mass Index (BMI) of 18-30 kg/m2
(inclusive);
4. Vital signs, physical examination, 12-lead ECG, and clinical laboratory tests results
are within normal range or beyond the normal range but are not clinically significant
at the discretion of the investigator.
5. Subjects who are able to use effective methods of contraception throughout the study
and within 6 months after the last administration of the investigational product
(refer to Appendix 3 for details);
6. Subjects who are able to cooperate with the investigator, comply with study
requirements and complete the study in accordance with relevant procedures of the
protocol.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Subjects with positive hepatitis B surface antigen (HBsAg), HCV antibody or HIV
antibody; or subjects with concomitant drug-induced or autoimmune hepatopathy (e.g.
positive antinuclear antibody [ANA])
2. Medical history of organ transplant or malignancy.
3. Subjects with clinically significant allergic disease or allergic predisposition or
with clear allergy to this product or its composition.
4. Subjects with a history of any serious clinical disease or with clear circulatory
system, endocrine system, central nervous system, cardiovascular system, digestive
system, respiratory system, urinary system, blood system, immune system or metabolic
disorder, or with other diseases inappropriate for entry into this study (e.g. history
of psychosis), which are clinically significant at the discretion of the investigator.
5. Creatinine clearance (Ccr) <60ml/min [calculation formula: Ccr: (140-age)×body weight
(kg)/0.818×Scr (µmol/L), female ×0.85].
6. History of immune-mediated disease (such as: primary thrombocytopaenic purpura,
systemic lupus erythematosis, rheumatoid arthritis, autoimmune hemolytic anemia,
serious psoriasis, or any other autoimmune disease) which is clinically significant at
the discretion of the investigator.
7. Subjects with acute infection (e.g. influenza) in recent 2 weeks.
8. Subjects who have participated in another clinical study and have received another
investigational drug within 1 months before treatment initiation.
9. Subjects with other factors which are unsuitable for study participation at the
discretion of the investigators.
NOTE: additional inclusion/exclusion criteria may apply, per protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/11/2021
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Scientia Clinical Research Ltd - Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Suzhou Ribo Life Science Co. Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a single dose-escalation phase ?a clinical study to observe the safety and
pharmacokinetic profiles of RBD1016 in healthy subjects.
The study consists of screening period (Day -28 to Day -1), treatment period (Day 1 to Day
2), safety assessment period (to Day 29) and safety follow-up period (up to Day 85).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04685564
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Charlotte Dr. Lemech
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Address
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Scientia Clinical Research Ltd.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04685564
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