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

Sunshine Guojian Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 611; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04527718

SSGJ-611-HV-I-A

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups

Cohort 1

Experimental group

Description:

611 dose 1 (45mg) plus placebo

Treatment:

Drug: 611

Drug: Placebo

Cohort 2

Experimental group

Description:

611 dose 2 (150mg) plus placebo

Treatment:

Drug: 611

Drug: Placebo

Cohort 3

Experimental group

Description:

611 dose 3 (300mg) plus placebo

Treatment:

Drug: 611

Drug: Placebo

Cohort 4

Experimental group

Description:

611 dose 4 (450mg) plus placebo

Treatment:

Drug: 611

Drug: Placebo

Cohort 5

Experimental group

Description:

611 dose 5 (600mg) plus placebo

Treatment:

Drug: 611

Drug: Placebo