A Study of NBL-012 in Healthy Chinese Subjects
- Conditions
- Healthy Subjects
- Interventions
- Drug: NBL-012 InjectionDrug: Placebo
- Registration Number
- NCT05259189
- Lead Sponsor
- NovaRock Biotherapeutics, Ltd
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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,
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description NBL-012 Injection 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 Placebo Placebo 2 out of 10 healthy subjects will be randomized to receive a single dose of placebo.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
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
Name Time Method Time to achieve maximum plasma concentration (Tmax) 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 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 Apparent clearance(CL/F) of NBL-012 injection 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 The incidence of Anti-drug antibody (ADA)
Free IL-23 concentration in Serum. Pre-dose and multiple timepoints up to 113 days post-dose Free IL-23 concentration in Serum.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University.
🇨🇳Suzhou, Jiangsu, China