A Study of NBL-012 in Healthy Chinese Subjects

NovaRock Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: NBL-012 Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05259189

NBL-012-CSP-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 52 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

NBL-012 Injection

Experimental group

Description:

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

Treatment:

Drug: NBL-012 Injection

Placebo

Placebo Comparator group

Description:

2 out of 10 healthy subjects will be randomized to receive a single dose of placebo.

Treatment:

Drug: Placebo