Healthy Subjects
Conditions
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
Interventions
DRUGNBL-012 Injection
a single subcutaneous injection
DRUGPlacebo
a single subcutaneous injection
Sponsors
NovaRock Biotherapeutics, Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 body temperature in degrees Celsius. |
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) of NBL-012 injection | Pre-dose and multiple timepoints up to 113 days post-dose | — |
| Free IL-23 concentration in Serum. | Pre-dose and multiple timepoints up to 113 days post-dose | Free IL-23 concentration in Serum. |
| 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) | Pre-dose and multiple timepoints up to 113 days post-dose | The incidence of Anti-drug antibody (ADA) |
Countries
China
Outcome results
None listed