Clinical trial NCT05259189: A Study of NBL-012 in Healthy Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: NovaRock Biotherapeutics, Ltd
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in 12-lead electrocardiogram (ECG) examination will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in physical examination will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in vital signs examination will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in routine blood test will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in blood biochemistry test will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
measure: Clinically significant changes from baseline in routine urine test will be recorded as AEs at each visit time point.
timeFrame: Up to Day 113 from screening
Secondary outcomes:
measure: Peak plasma concentration (Cmax) of NBL-012 injection
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: Area under the plasma concentration versus time curve (AUC) of NBL-012 injection
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: Time to achieve maximum plasma concentration (Tmax) of NBL-012 injection
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: Apparent clearance(CL/F) of NBL-012 injection
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: Apparent volume of Distribution(Vz/F) of NBL-012 injection
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: Half-life(t1/2) of NBL-012 injection
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: The incidence of Anti-drug antibody (ADA)
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
measure: Free IL-23 concentration in Serum.
timeFrame: Pre-dose and multiple timepoints up to 113 days post-dose
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University.
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: