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

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.1 site in 1 country62 target enrollmentNovember 25, 2019

ConditionsModerate to Severe Plaque Psoriasis

Interventions608 Placebo

Drugs608 Placebo

Overview

Phase: Phase 1
Intervention: 608
Conditions: Moderate to Severe Plaque Psoriasis
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Enrollment: 62
Locations: 1
Primary Endpoint: AE/SAEs
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 25, 2019

End Date

October 31, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects aged 18 to 45 years;
•Good health status (no significant clinical symptoms and signs and no clinical significance of abnormal laboratory test).
•The body weight no less than 50 kg for male subjects and no less than 45 kg for female subjects. Body mass index (BMI) = weight (kg)/square of height, ranging from 19-26kg/m2 (including the critical value)
•Voluntary written informed consent;
•Being able to complete the study according to the requirements in the study protocol
•The person who have undergone surgical treatment have fully recovered

Exclusion Criteria

•Allergic constitution or history of allergy to two or more substances; Known hypersensitivity to any biotherapy; Allergy to rubber or latex; Allergy to study drug or any components of study drug by investigator assessment
•Participation in any other clinical study about drugs or medical instruments within 3 months prior to enroll, or subjects currently included in the study which are not scientifically or medically compatible with this study
•Use of any medicine within 5 half-lives or less than 4 weeks prior to enroll (the longer of the two shall prevail)
•Participation in any IL-17 antagonists at any time
•Used vaccination or participation in any other clinical vaccination study within 12 weeks prior to enroll, or plan to use vaccine during the study or within 12 months after the study
•Any major surgery within 8 weeks prior to enroll, or requiring such surgery during the study
•Having history of any clinically significant diseases, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, nerves and mental system, hematological system, Immune diseases, abnormal metabolism, etc
•History of or current Inflammatory Bowel Disease
•Loss or donation of blood ≥200mL within 12 weeks prior to enroll, or receiving blood transfusion in recent 8 weeks; or plan to donate blood during the study
•Positive HIV antibody or positive treponema pallidum serum specific antibody;

Arms & Interventions

608

8mg, 20mg, 40mg, 80mg, 120mg, 160mg, 200mg

Intervention: 608

Placebo

20mg, 40mg, 80mg, 120mg, 160mg, 200mg

Intervention: Placebo

Outcomes

Primary Outcomes

AE/SAEs

Time Frame: From baseline through overall study (follow-up period: the arm of 8mg, 20mg,40mg with 71 days; 80mg, 120mg,160mg, 200mg with 91 days)

Incidence of treatment emergent AE/SAEs

Secondary Outcomes

Cmax(From baseline through 71days/91day)
Tmax(From baseline through 71days/91day)
AUClast(From baseline through 71days/91day)
AUCinf(From baseline through 71days/91day)
CL(From baseline through 71days/91day)
Vd(From baseline through 71days/91day)
T1/2(From baseline through 71days/91day)
MRT(From baseline through 71days/91day)
λz(From baseline through 71days/91day)
Percentage of Participants With Anti-608 Antibodies(From baseline through 71days/91day.)