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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527718
• Other study ID #: SSGJ-611-HV-I-A
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2020
• Est. completion date: August 13, 2021

Study information

• Verified date: November 2022
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 13, 2021
• Est. primary completion date: August 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo
placebo as a single SC injection on Day 1;
• 611
611 as a single SC injection on Day 1;

Locations

Country	Name	City	State
United States	Covance Dallas Clinical Research Unit	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK	PK parameters not limit to Cmax	up to 71days (90 days for Cohorts 1 and 2)
Secondary	Incidence of immunogenicity	ADA, and NAbs if ADA is positive	up to 71days (90 days for Cohorts 1 and 2)