A Study of NBL-012 in Healthy Chinese Subjects

Launched by NOVAROCK BIOTHERAPEUTICS, LTD · Feb 17, 2022

Keywords

ClinConnect Summary

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

Gender

ALL

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