NCT04367441

Randomized, Double Blinded, Placebo Controlled, Single Dose Escalation Study of 608 in Healthy Subjects

A Study of Single Dose Escalation, Randomized, Double Blinded, Placebo Controlled to Investigate the Tolerability, Safety Profiles, Pharmacokinetic of Recombinant Humanized Anti-IL17A Monoclonal Antibody Injection in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, phase 1, single-center, randomized, double blinded, placebo-controlled, single dose-escalation study to evaluate the safety, tolerability, PK, of 608 following subcutaneous injection in healthy subjects.

Detailed description

The study will consist of a 14-days screening period (-14\~-1 days); an observation period (7-14 days) and the follow-up period (71-91days); Subjects will be randomly assigned to seven group.

Conditions

• Moderate to Severe Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	608	recombinant humanized anti-IL17A monoclonal antibody injection
DRUG	Placebo	auxiliary material of 608 include histidine, histidine hydrochloride, sucrose and polysorbate 80

Timeline

• Start date: 2019-11-25
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2020-04-29
• Last updated: 2020-04-29

Locations

1 site across 1 country: China