Healthy VolunteersPhase 1NCT04685564
A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016
A Phase 1 study testing RBD1016 in people with Healthy Volunteers, run by Suzhou Ribo Life Science Co. Ltd. at 1 site in Australia.
Trial summary
This is a single dose-escalation phase Ⅰa 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RBD1016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Feb 2021to 2 Nov 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing;
- Male or female volunteers aged between 18 and 45 years (inclusive);
- Body weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) of 18-30 kg/m2 (inclusive);
- 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.
- 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);
- 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.
Who cannot join
- 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])
- Medical history of organ transplant or malignancy.
- Subjects with clinically significant allergic disease or allergic predisposition or with clear allergy to this product or its composition.
- 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.
- Creatinine clearance (Ccr) <60ml/min [calculation formula: Ccr: (140-age)×body weight (kg)/0.818×Scr (μmol/L), female ×0.85].
- 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.
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- Subjects with acute infection (e.g. influenza) in recent 2 weeks.
- Subjects who have participated in another clinical study and have received another investigational drug within 1 months before treatment initiation.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This is a single dose-escalation phase Ⅰa 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).
Read the detailed description
It is a randomized, double-blind, placebo-controlled, single dose-escalation, phase Ia study. The study will enroll 40 healthy subjects, including 5 dose escalation cohorts for dose escalation with 0.3 mg/kg body weight as the starting dose.
After a single-dose injection, there will be a 4-week safety assessment and monitoring phase (Days 1-29). Blood samples for PK analysis will be collected within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after dosing, respectively. According to the previous PK results, the subsequent PK blood collection points can be adjusted. Total urine samples will be collected once before dosing and in each of 2 time periods after dosing: 0~8 h and 8~24 h. The total urine output will be recorded, and some urine samples will be collected in each time period to analyze and detect the urine drug concentration.
Subjects will undergo safety follow-up from Day 29 to Day 85.
- Conditions
- Healthy Volunteers
- Being tested
- RBD1016, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD1016Drug
"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.
PlaceboDrug
the same as RBD1016
| Study group | Role | What they receive |
|---|---|---|
| RBD1016 experiment group | Experimental | Subjects in experiment groups will receive a single subcutaneous injection of RBD1016. Receives: Drug: RBD1016 |
| placebo gruop | Placebo comparator | Subjects in placebo groups will receive a single subcutaneous injection of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety assessment, AE and SAE of ascending single dose of RBD1016 in healthy subjects.
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed by CTCAE v5.0.
Measured: up to Day 29
To evaluate the safety assessment, 12-lead ECG of ascending single dose of RBD1016 in healthy subjects.
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.
Measured: up to Day 29
To evaluate the safety assessment, vital signs of ascending single dose of RBD1016 in healthy subjects.
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.
Measured: up to Day 29
To evaluate the safety assessment, physical examinations of ascending single dose of RBD1016 in healthy subjects.
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.
Measured: up to Day 29
To evaluate the safety assessment, clinical lab examinations of ascending single dose of RBD1016 in healthy subjects.
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).
Measured: up to Day 29
Secondary outcomes (7)
To characterize the pharmacokinetic parameter Cmax of RBD1016 in healthy subjects.
Maximum concentration (Cmax)
Measured: 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
To characterize the pharmacokinetic parameter AUC0-t of RBD1016 in healthy subjects.
Area under the concentration-time curve from 0 to the collection time t (AUC0-t)
Measured: 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
To characterize the pharmacokinetic paramete AUC0-inf of RBD1016 in healthy subjects.
Area under the concentration-time curve from 0 to infinity (inf) (AUC0-inf)
Measured: 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
To characterize the pharmacokinetic paramete Tmax of RBD1016 in healthy subjects.
Time to maximum concentration (Tmax)
Measured: 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
To characterize the pharmacokinetic paramete t1/2 of RBD1016 in healthy subjects.
Plasma Half-Life (t1/2)
Measured: 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
To characterize the pharmacokinetic paramete Vz/F of RBD1016 in healthy subjects.
Volume of distribution in the terminal elimination period (Vz/F)
Measured: 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
To characterize the pharmacokinetic paramete λz of RBD1016 in healthy subjects.
Terminal rate constant (λz)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start5 Feb 2021
- Primary completion8 Sep 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotte Dr. Lemech, Principal investigator, Scientia Clinical Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685564
- Sponsor's protocol ID
- RBHB1101-A
- Status last verified
- Apr 2022
- First submitted
- 8 Dec 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04685564
- Acronym / sponsor ID
- RBHB1101-A
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Suzhou Ribo Life Science Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 28 Dec 2020 (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.
This is a single dose-escalation phase Ⅰa 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).
Detailed description
It is a randomized, double-blind, placebo-controlled, single dose-escalation, phase Ia study. The study will enroll 40 healthy subjects, including 5 dose escalation cohorts for dose escalation with 0.3 mg/kg body weight as the starting dose.
After a single-dose injection, there will be a 4-week safety assessment and monitoring phase (Days 1-29). Blood samples for PK analysis will be collected within 60 minutes before dosing, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after dosing, respectively. According to the previous PK results, the subsequent PK blood collection points can be adjusted. Total urine samples will be collected once before dosing and in each of 2 time periods after dosing: 0~8 h and 8~24 h. The total urine output will be recorded, and some urine samples will be collected in each time period to analyze and detect the urine drug concentration.
Subjects will undergo safety follow-up from Day 29 to Day 85.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RBD1016 experiment group | Experimental | Drug: RBD1016Subjects in experiment groups will receive a single subcutaneous injection of RBD1016. |
| placebo gruop | Placebo comparator | Drug: PlaceboSubjects in placebo groups will receive a single subcutaneous injection of placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing;
- Male or female volunteers aged between 18 and 45 years (inclusive);
- Body weight: male ≥ 50 kg, female ≥ 45 kg; Body Mass Index (BMI) of 18-30 kg/m2 (inclusive);
- 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.
- 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);
Key exclusion criteria (10 listed)
- 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])
- Medical history of organ transplant or malignancy.
- Subjects with clinically significant allergic disease or allergic predisposition or with clear allergy to this product or its composition.
- 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.
- Creatinine clearance (Ccr) <60ml/min [calculation formula: Ccr: (140-age)×body weight (kg)/0.818×Scr (μmol/L), female ×0.85].
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 |
|---|---|---|
| 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. | Drug | RBD1016 experiment group |
| Placebothe same as RBD1016 | Drug | placebo gruop |
Primary outcome
To evaluate the safety assessment, AE and SAE of ascending single dose of RBD1016 in healthy subjects.
Time frame: up to Day 29
Incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed by CTCAE v5.0.
To evaluate the safety assessment, 12-lead ECG of ascending single dose of RBD1016 in healthy subjects.
Time frame: up to Day 29
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.
To evaluate the safety assessment, vital signs of ascending single dose of RBD1016 in healthy subjects.
Time frame: up to Day 29
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.
To evaluate the safety assessment, physical examinations of ascending single dose of RBD1016 in healthy subjects.
Time frame: up to Day 29
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.
To evaluate the safety assessment, clinical lab examinations of ascending single dose of RBD1016 in healthy subjects.
Time frame: up to Day 29
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).
7 secondary outcomes
To characterize the pharmacokinetic parameter Cmax of RBD1016 in healthy subjects.
Time frame: 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
To characterize the pharmacokinetic parameter AUC0-t of RBD1016 in healthy subjects.
Time frame: 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
To characterize the pharmacokinetic paramete AUC0-inf of RBD1016 in healthy subjects.
Time frame: 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
To characterize the pharmacokinetic paramete Tmax of RBD1016 in healthy subjects.
Time frame: 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
To characterize the pharmacokinetic paramete t1/2 of RBD1016 in healthy subjects.
Time frame: 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
To characterize the pharmacokinetic paramete Vz/F of RBD1016 in healthy subjects.
Time frame: 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
To characterize the pharmacokinetic paramete λz of RBD1016 in healthy subjects.
Time frame: 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
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 26 Apr 2022.
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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.
Charlotte Dr. Lemech principal investigator
Scientia Clinical Research Ltd.
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 RBD1016 in people with Healthy Volunteers, run by Suzhou Ribo Life Science Co. 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 6 inclusion and 10 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 26 Apr 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. Some participants in this study may receive a placebo. 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?
To evaluate the safety assessment, AE and SAE of ascending single dose of RBD1016 in healthy subjects. (time frame: up to Day 29). The study lists 5 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 26 Apr 2022.