A Study of NBL-012 in Healthy Chinese Subjects

Sponsor
NovaRock Biotherapeutics, Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05259189
Collaborator
(none)
52
1
2
10.7
4.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NBL-012 Injection
  • Drug: Placebo
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
May 23, 2022
Actual Study Completion Date :
May 23, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [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. [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. [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. [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. [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. [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. [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. [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. [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. [Up to Day 113 from screening]

    Routine urine test includes glucose and protein in mg/dL.

Secondary Outcome Measures

  1. Peak plasma concentration (Cmax) of NBL-012 injection [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 [Pre-dose and multiple timepoints up to 113 days post-dose]

  3. Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection [Pre-dose and multiple timepoints up to 113 days post-dose]

  4. Apparent clearance(CL/F) of NBL-012 injection [Pre-dose and multiple timepoints up to 113 days post-dose]

  5. Apparent volume of Distribution(Vz/F) of NBL-012 injection [Pre-dose and multiple timepoints up to 113 days post-dose]

  6. Half-life(t1/2) of NBL-012 injection [Pre-dose and multiple timepoints up to 113 days post-dose]

  7. The incidence of Anti-drug antibody (ADA) [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. [Pre-dose and multiple timepoints up to 113 days post-dose]

    Free IL-23 concentration in Serum.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Soochow University. Suzhou Jiangsu China 215006

Sponsors and Collaborators

  • NovaRock Biotherapeutics, Ltd

Investigators

  • Principal Investigator: Liyan Miu, MD PhD, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NovaRock Biotherapeutics, Ltd
ClinicalTrials.gov Identifier:
NCT05259189
Other Study ID Numbers:
  • NBL-012-CSP-001
First Posted:
Feb 28, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 20, 2022