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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: 611

• Registration Number: NCT04527718
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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).

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-26
• Study Start: 2020-09-09
• Primary Completion: 2021-08-13
• Study Completion: 2021-08-13
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4	611	611 dose 4 (450mg) plus placebo
Cohort 2	Placebo	611 dose 2 (150mg) plus placebo
Cohort 2	611	611 dose 2 (150mg) plus placebo
Cohort 3	Placebo	611 dose 3 (300mg) plus placebo
Cohort 5	611	611 dose 5 (600mg) plus placebo
Cohort 1	611	611 dose 1 (45mg) plus placebo
Cohort 1	Placebo	611 dose 1 (45mg) plus placebo
Cohort 4	Placebo	611 dose 4 (450mg) plus placebo
Cohort 5	Placebo	611 dose 5 (600mg) plus placebo
Cohort 3	611	611 dose 3 (300mg) plus placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With TEAEs	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 Outcome Measures

Name	Time	Method
Incidence of immunogenicity	up to 71days (90 days for Cohorts 1 and 2)	ADA, and NAbs if ADA is positive
PK	up to 71days (90 days for Cohorts 1 and 2)	PK parameters not limit to Cmax

Trial Locations

Locations (1)

Covance Dallas Clinical Research Unit; 🇺🇸 Dallas, Texas, United States