A Study of NBL-012 in Healthy Chinese Subjects

July 19, 2022 updated by: NovaRock Biotherapeutics, Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive) at screening.
  2. Body Mass Index (BMI) of 18 to 26 kg/m2 (inclusive), body weight for male ≥50 kg and for female≥45 kg.
  3. 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,

Exclusion Criteria:

  1. Participated in any drug or medical device clinical trial within 3 months before screening
  2. Pregnant or nursing (lactating) women who have a positive blood/urine pregnancy test.
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: NBL-012 Injection
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
Drug: NBL-012 Injection
a single subcutaneous injection
PLACEBO_COMPARATOR: Placebo
2 out of 10 healthy subjects will be randomized to receive a single dose of placebo.
Drug: Placebo
a single subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
Time Frame: Up to Day 113 from screening
ECG monitoring includes heart rate in bpm.
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.
Time Frame: Up to Day 113 from screening
ECG monitoring includes P-R, QT and QTc intervals in ms.
Up to Day 113 from screening
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.
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.
Time Frame: Up to Day 113 from screening
Vital signs monitoring includes body temperature in degrees Celsius.
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.
Time Frame: Up to Day 113 from screening
Vital signs monitoring includes respiratory rate and pulse in times per minute.
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.
Time Frame: Up to Day 113 from screening
Vital signs monitoring includes systolic blood pressure and diastolic blood pressure in mmHg.
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.
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.
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.
Time Frame: Up to Day 113 from screening
Blood biochemistry test includes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and glutamyltranspeptidase in U/L.
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.
Time Frame: Up to Day 113 from screening
Routine urine test includes glucose and protein in mg/dL.
Up to Day 113 from screening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak plasma concentration (Cmax) of NBL-012 injection
Time Frame: Pre-dose and multiple timepoints up to 113 days post-dose
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
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
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
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
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
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
The incidence of Anti-drug antibody (ADA)
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
Free IL-23 concentration in Serum.
Pre-dose and multiple timepoints up to 113 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NovaRock Biotherapeutics, Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Liyan Miu, MD PhD, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 23, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBL-012-CSP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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