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Completed

NCT Number: NCT05259189

A Study 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University.

Suzhou, Jiangsu, 215006, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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

Treatment and study plan

NBL-012 Injection

Drug

a single subcutaneous injection

Placebo

Drug

a single subcutaneous injection

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. Peak plasma concentration (Cmax) of NBL-012 injection

    Time frame: Pre-dose and multiple timepoints up to 113 days post-dose

  2. 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

  3. Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection

    Time frame: Pre-dose and multiple timepoints up to 113 days post-dose

  4. Apparent clearance(CL/F) of NBL-012 injection

    Time frame: Pre-dose and multiple timepoints up to 113 days post-dose

  5. Apparent volume of Distribution(Vz/F) of NBL-012 injection

    Time frame: Pre-dose and multiple timepoints up to 113 days post-dose

  6. Half-life(t1/2) of NBL-012 injection

    Time frame: Pre-dose and multiple timepoints up to 113 days post-dose

  7. 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)

  8. 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.

Sponsors and collaborators

Lead sponsor

NovaRock Biotherapeutics, Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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