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

NCT04367441 | Unknown Phase 1

• 1 other identifier: SSGJ -608- Psoriasis-I-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• AE/SAEs

  Incidence of treatment emergent AE/SAEs

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

Secondary Outcomes (10)

• 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

Study Arms (2)

608

EXPERIMENTAL

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

Drug: 608

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

608 DRUG

recombinant humanized anti-IL17A monoclonal antibody injection

608

Placebo DRUG

auxiliary material of 608 include histidine, histidine hydrochloride, sucrose and polysorbate 80

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Positive hepatitis B surface antigen, or positive hepatitis B core antibody and negative hepatitis B surface antibody
• Positive hepatitis C antibody
• History of or current lymphatic proliferative disease; Sign or symptom of lymphatic proliferative disease; History of or current malignant tumor
• Serious infection (e.g., pneumonia, cellulitis) or varicella-zoster virus infection, hospitalization, infection using antibiotics by intravenous injection within 12 weeks prior to enroll; serious bone and joint infection witn 24 weeks prior to enroll; or happened artificial joint infections; any infection within 7 days (include chronic or local infection ,such as a local skin infection); or history of recurrent infections and prone to infections of the basic diseases ((including but not limited to herpes zoster virus (\> 1 time) and herpes simplex virus infection); history of any immunological injuries(pneumocystis pneumonia, histoplasmosis, or coccidioidomycosis);
• Having clinical evidence of active tuberculosis or suspected for active TB, or previous evidence of active TB but not received appropriate treatment or missing records; or latent tuberculosis infection at screening;

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Public Health Clinical Center (Shanghai)

Zhujing, Shanghai Municipality, 201508, China

RECRUITING

Central Study Contacts

Hongzhou Lu, PhD

CONTACT

(021)37990333-5278; luhongzhou@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 29, 2020
• Study Start: November 25, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

CN (1)