NCT04527718

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Placebo	placebo as a single SC injection on Day 1;
DRUG	611	611 as a single SC injection on Day 1;

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2020-08-26
• Last updated: 2022-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study