A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of 611 in Adult Healthy Male and Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With TEAEs
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand and willing to sign the ICF
- •Healthy male and female subjects, non-smokers, 18-55 years of age
- •In the opinion of the investigator, with no significant medical history, and in good health.
- •Body mass index 19.0-32.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- •Subjects are able to follow the study protocol and complete the trial.
Exclusion Criteria
- •History of hypersensitivity to similar drugs to 611 or their excipients.
- •Pregnant, or nursing females.
- •HepBsAg or HepCAb positive.
- •Human immunodeficiency virus (HIV) positive.
- •Positive urine drug screen, or cotinine test.
- •Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Arms & Interventions
Cohort 1
611 dose 1 (45mg) plus placebo
Intervention: Placebo
Cohort 1
611 dose 1 (45mg) plus placebo
Intervention: 611
Cohort 2
611 dose 2 (150mg) plus placebo
Intervention: Placebo
Cohort 2
611 dose 2 (150mg) plus placebo
Intervention: 611
Cohort 3
611 dose 3 (300mg) plus placebo
Intervention: Placebo
Cohort 3
611 dose 3 (300mg) plus placebo
Intervention: 611
Cohort 4
611 dose 4 (450mg) plus placebo
Intervention: Placebo
Cohort 4
611 dose 4 (450mg) plus placebo
Intervention: 611
Cohort 5
611 dose 5 (600mg) plus placebo
Intervention: Placebo
Cohort 5
611 dose 5 (600mg) plus placebo
Intervention: 611
Outcomes
Primary Outcomes
Percentage of Participants With TEAEs
Time Frame: up to 71days (90 days for Cohorts 1 and 2)
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.
Secondary Outcomes
- Incidence of immunogenicity(up to 71days (90 days for Cohorts 1 and 2))
- PK(up to 71days (90 days for Cohorts 1 and 2))