Status:
COMPLETED
A Study of NBL-012 in Healthy Chinese Subjects
Lead Sponsor:
NovaRock Biotherapeutics, Ltd
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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) admin...
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 asce...
Eligibility Criteria
Inclusion
- 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,
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05259189
Start Date
July 1 2021
End Date
May 23 2022
Last Update
July 20 2022
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University.
Suzhou, Jiangsu, China, 215006