Healthy SubjectsPhase 1NCT05259189
A Study of NBL-012 in Healthy Chinese Subjects
A Phase 1 study testing NBL-012 Injection in people with Healthy Subjects, run by NovaRock Biotherapeutics, Ltd at 1 site in China.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- NBL-012 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 23 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive) at screening.
- Body Mass Index (BMI) of 18 to 26 kg/m2 (inclusive), body weight for male ≥50 kg and for female≥45 kg.
- Good general health defined as no clinically significant abnormalities identified by a detailed medical history (thoracic and abdominal examination, nervous and mental system examination, etc.), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG,
Who cannot join
- Participated in any drug or medical device clinical trial within 3 months before screening
- Pregnant or nursing (lactating) women who have a positive blood/urine pregnancy test.
- Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until the end of study visit (more than 15 weeks after drug administration), or subjects with a plan to give birth wi
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University.
Suzhou, Jiangsu, 215006
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NBL-012 in Healthy Chinese Subjects
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to healthy Chinese subjects.
Read the detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics of NBL-012 administered subcutaneously as single ascending doses (SAD) to healthy Chinese subjects. Six dose cohorts will be intended for enrollment. The first dose will be sentinel group which will consist of 2 subjects, both of whom will receive active NBL-012. For subsequent dose cohorts, subjects will be given a single escalating SC dose of NBL-01
- Conditions
- Healthy Subjects
- Being tested
- NBL-012 Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBL-012 InjectionDrug
a single subcutaneous injection
PlaceboDrug
a single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| NBL-012 Injection | Experimental | Two subjects will be enrolled in the initial dose. 8 out of 10 healthy subjects will be randomized to receive a single dose of NBL-012 Injection for subsequent dose cohorts Receives: Drug: NBL-012 Injection |
| Placebo | Placebo comparator | 2 out of 10 healthy subjects will be randomized to receive a single dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events will be assessed by CTCAE v5.0. The AEs will be summarized according to the system organ class (SOC) and preferred term (PT), including the number and percentage of participants who had AEs.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
ECG monitoring includes heart rate in bpm.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
ECG monitoring includes P-R, QT and QTc intervals in ms.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.
Physical examination includes general conditions, skin, neck, chest, spine, limbs, nervous system, and lymphatic system.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Vital signs monitoring includes body temperature in degrees Celsius.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Vital signs monitoring includes respiratory rate and pulse in times per minute.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.
Routine blood test includes white blood cell count, platelet, neutrophilic granulocyte count, lymphocyte count and monocyte count in 10^9 /L.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.
Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and glutamyltranspeptidase in U/L.
Measured: Up to Day 113 from screening
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
Routine urine test includes glucose and protein in mg/dL.
Measured: Up to Day 113 from screening
Secondary outcomes (8)
Peak plasma concentration (Cmax) of NBL-012 injection
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Area under the plasma concentration versus time curve (AUC) of NBL-012 injection
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Apparent clearance(CL/F) of NBL-012 injection
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Apparent volume of Distribution(Vz/F) of NBL-012 injection
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Half-life(t1/2) of NBL-012 injection
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
The incidence of Anti-drug antibody (ADA)
The incidence of Anti-drug antibody (ADA)
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Free IL-23 concentration in Serum.
Free IL-23 concentration in Serum.
Measured: Pre-dose and multiple timepoints up to 113 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Jul 2021
- Primary completion23 May 2022
- Study completion23 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaRock Biotherapeutics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miu, MD PhD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259189
- Sponsor's protocol ID
- NBL-012-CSP-001
- Status last verified
- Jul 2022
- First submitted
- 29 Jan 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NBL-012 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05259189
- Acronym / sponsor ID
- NBL-012-CSP-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NovaRock Biotherapeutics, LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 23 May 2022 (actual)
- Study completion
- 23 May 2022 (actual)
- First posted
- 28 Feb 2022 (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 phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to healthy Chinese subjects.
Detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics of NBL-012 administered subcutaneously as single ascending doses (SAD) to healthy Chinese subjects. Six dose cohorts will be intended for enrollment. The first dose will be sentinel group which will consist of 2 subjects, both of whom will receive active NBL-012. For subsequent dose cohorts, subjects will be given a single escalating SC dose of NBL-01
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBL-012 Injection | Experimental | Drug: NBL-012 InjectionTwo subjects will be enrolled in the initial dose. 8 out of 10 healthy subjects will be randomized to receive a single dose of NBL-012 Injection for subsequent dose cohorts |
| Placebo | Placebo comparator | Drug: Placebo2 out of 10 healthy subjects will be randomized to receive a single dose of placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive) at screening.
- Body Mass Index (BMI) of 18 to 26 kg/m2 (inclusive), body weight for male ≥50 kg and for female≥45 kg.
- Good general health defined as no clinically significant abnormalities identified by a detailed medical history (thoracic and abdominal examination, nervous and mental system examination, etc.), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG,
Key exclusion criteria (3 listed)
- Participated in any drug or medical device clinical trial within 3 months before screening
- Pregnant or nursing (lactating) women who have a positive blood/urine pregnancy test.
- Females of child-bearing potential (defined as all females physiologically capable of becoming pregnant) and males who are unwilling or unable to use effective contraception during the study and until the end of study visit (more than 15 weeks after drug administration), or subjects with a plan to give birth wi
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 |
|---|---|---|
| NBL-012 Injectiona single subcutaneous injection | Drug | NBL-012 Injection |
| Placeboa single subcutaneous injection | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to Day 113 from screening
Number of participants with treatment-related adverse events will be assessed by CTCAE v5.0. The AEs will be summarized according to the system organ class (SOC) and preferred term (PT), including the number and percentage of participants who had AEs.
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
ECG monitoring includes heart rate in bpm.
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
ECG monitoring includes P-R, QT and QTc intervals in ms.
Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Physical examination includes general conditions, skin, neck, chest, spine, limbs, nervous system, and lymphatic system.
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Vital signs monitoring includes body temperature in degrees Celsius.
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Vital signs monitoring includes respiratory rate and pulse in times per minute.
Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg.
Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Routine blood test includes white blood cell count, platelet, neutrophilic granulocyte count, lymphocyte count and monocyte count in 10^9 /L.
Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and glutamyltranspeptidase in U/L.
Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
Time frame: Up to Day 113 from screening
Routine urine test includes glucose and protein in mg/dL.
8 secondary outcomes
Peak plasma concentration (Cmax) of NBL-012 injection
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
Area under the plasma concentration versus time curve (AUC) of NBL-012 injection
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
Apparent clearance(CL/F) of NBL-012 injection
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
Apparent volume of Distribution(Vz/F) of NBL-012 injection
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
Half-life(t1/2) of NBL-012 injection
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
The incidence of Anti-drug antibody (ADA)
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
Free IL-23 concentration in Serum.
Time frame: Pre-dose and multiple timepoints up to 113 days post-dose
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 20 Jul 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.
Liyan Miu, MD PhD principal investigator
The First Affiliated Hospital of Soochow University
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 NBL-012 Injection in people with Healthy Subjects, run by NovaRock Biotherapeutics, Ltd at 1 site in China.
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 3 inclusion and 3 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 20 Jul 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 China. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Up to Day 113 from screening). The study lists 10 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 20 Jul 2022.