A Study of NBL-012 in Healthy Chinese Subjects

NovaRock Biotherapeutics, Ltd52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Subjects

Interventions

NBL-012 InjectionDRUG

a single subcutaneous injection

PlaceboDRUG

a single subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital of Soochow University.

Suzhou, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 113 from screening

Data from ClinicalTrials.gov

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