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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
RBHB1101-A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety assessment, AE and SAE of ascending single dose of RBD1016 in healthy subjects.
Timepoint [1] 0 0
up to Day 29
Primary outcome [2] 0 0
To evaluate the safety assessment, 12-lead ECG of ascending single dose of RBD1016 in healthy subjects.
Timepoint [2] 0 0
up to Day 29
Primary outcome [3] 0 0
To evaluate the safety assessment, vital signs of ascending single dose of RBD1016 in healthy subjects.
Timepoint [3] 0 0
up to Day 29
Primary outcome [4] 0 0
To evaluate the safety assessment, physical examinations of ascending single dose of RBD1016 in healthy subjects.
Timepoint [4] 0 0
up to Day 29
Primary outcome [5] 0 0
To evaluate the safety assessment, clinical lab examinations of ascending single dose of RBD1016 in healthy subjects.
Timepoint [5] 0 0
up to Day 29
Secondary outcome [1] 0 0
To characterize the pharmacokinetic parameter Cmax of RBD1016 in healthy subjects.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
To characterize the pharmacokinetic parameter AUC0-t of RBD1016 in healthy subjects.
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
To characterize the pharmacokinetic paramete AUC0-inf of RBD1016 in healthy subjects.
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
To characterize the pharmacokinetic paramete Tmax of RBD1016 in healthy subjects.
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
To characterize the pharmacokinetic paramete t1/2 of RBD1016 in healthy subjects.
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
To characterize the pharmacokinetic paramete Vz/F of RBD1016 in healthy subjects.
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
To characterize the pharmacokinetic paramete ?z of RBD1016 in healthy subjects.
Timepoint [7] 0 0
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

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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2021
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Suzhou Ribo Life Science Co. Ltd.
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT04685564
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charlotte Dr. Lemech
Address 0 0
Scientia Clinical Research Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04685564