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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04527718

Run by

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

People needed

40

Starts

2020-09-09

Expected to finish

2021-08-13

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Covance Dallas Clinical Research Unit — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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