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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: 611


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>611 dose 1 (45mg) plus placebo | Drug: Placebo<br>* placebo as a single SC injection on Day 1;<br>Drug: 611<br>* 611 as a single SC injection on Day 1;<br>|
| Experimental: Cohort 2<br>611 dose 2 (150mg) plus placebo | Drug: Placebo<br>* placebo as a single SC injection on Day 1;<br>Drug: 611<br>* 611 as a single SC injection on Day 1;<br>|
| Experimental: Cohort 3<br>611 dose 3 (300mg) plus placebo | Drug: Placebo<br>* placebo as a single SC injection on Day 1;<br>Drug: 611<br>* 611 as a single SC injection on Day 1;<br>|
| Experimental: Cohort 4<br>611 dose 4 (450mg) plus placebo | Drug: Placebo<br>* placebo as a single SC injection on Day 1;<br>Drug: 611<br>* 611 as a single SC injection on Day 1;<br>|
| Experimental: Cohort 5<br>611 dose 5 (600mg) plus placebo | Drug: Placebo<br>* placebo as a single SC injection on Day 1;<br>Drug: 611<br>* 611 as a single SC injection on Day 1;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 71days (90 days for Cohorts 1 and 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK | PK parameters not limit to Cmax | up to 71days (90 days for Cohorts 1 and 2) | 
| Incidence of immunogenicity | ADA, and NAbs if ADA is positive | up to 71days (90 days for Cohorts 1 and 2) |