Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.40 enrolled

Overview

This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of 611 in healthy volunteers.

Total duration of the study period per subject is about 4 months broken down as follows: The screening period is up to 28 days, one dose treatment, and follow- up period is up to 71±7 days (90±9 days for Cohorts 1 and 2).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PlaceboDRUG

placebo as a single SC injection on Day 1;

611DRUG

611 as a single SC injection on Day 1;

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able to understand and willing to sign the ICF 2. Healthy male and female subjects, non-smokers, 18-55 years of age 3. In the opinion of the investigator, with no significant medical history, and in good health. 4. Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. 5. Subjects are able to follow the study protocol and complete the trial. Exclusion Criteria: 1. History of hypersensitivity to similar drugs to 611 or their excipients. 2. Pregnant, or nursing females. 3. HepBsAg or HepCAb positive. 4. Human immunodeficiency virus (HIV) positive. 5. Positive urine drug screen, or cotinine test. 6. Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.

Locations (1)

Covance Dallas Clinical Research Unit

Dallas, Texas, United States

Outcomes

Primary Outcomes

Percentage of Participants With TEAEs

Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.

Time frame: up to 71days (90 days for Cohorts 1 and 2)

Secondary Outcomes

PK parameters not limit to Cmax

Time frame: up to 71days (90 days for Cohorts 1 and 2)

Incidence of immunogenicity

ADA, and NAbs if ADA is positive

Time frame: up to 71days (90 days for Cohorts 1 and 2)

Data from ClinicalTrials.gov

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