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Completed

NCT Number: NCT04527718

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas Clinical Research Unit

Dallas, Texas, 75247, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

placebo as a single SC injection on Day 1;

611

Drug

611 as a single SC injection on Day 1;

Primary outcomes

  1. 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

  1. PK

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

    PK parameters not limit to Cmax

  2. Incidence of immunogenicity

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

    ADA, and NAbs if ADA is positive

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2020
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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