A Study of NBL-012 in Healthy Chinese Subjects

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: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: NBL-012 Injection; Drug: Placebo

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: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to Day 113 from screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of NBL-012 injection		Pre-dose and multiple timepoints up to 113 days post-dose
Area under the plasma concentration versus time curve (AUC) of NBL-012 injection		Pre-dose and multiple timepoints up to 113 days post-dose
Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection		Pre-dose and multiple timepoints up to 113 days post-dose
Apparent clearance(CL/F) of NBL-012 injection		Pre-dose and multiple timepoints up to 113 days post-dose
Apparent volume of Distribution(Vz/F) of NBL-012 injection		Pre-dose and multiple timepoints up to 113 days post-dose
Half-life(t1/2) of NBL-012 injection		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)	Pre-dose and multiple timepoints up to 113 days post-dose
Free IL-23 concentration in Serum.	Free IL-23 concentration in Serum.	Pre-dose and multiple timepoints up to 113 days post-dose

Collaborators and Investigators

• Sponsor: NovaRock Biotherapeutics, Ltd
• Investigators: Principal Investigator: Liyan Miu, MD PhD, The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ACTUAL): May 23, 2022
• Study Completion (ACTUAL): May 23, 2022

Study Registration Dates

• First Submitted: January 29, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID 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