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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion 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; - 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; - Known immune deficiency; or the subject with weakened immune system may have unacceptable risk if participating in this study.
  • - Pregnant, nursing, or planning pregnancy within 6 months(women) or planning to donate sperm or egg; pregnancy test positive; not use effective contraception (details for appendix 5) or the partner of the men subject planned to have a baby within 6 months; - History of definite neurological or psychiatric disorders:such as epilepsy; - History of alcohol or substance abuse with 14 units of alcohol per week within 6 months (1 unit =12 ounce or 360mL beer/1.5 ounce or 45ml liquor with 40% alcohol/5 ounce or 150mL wine); positive of alcohol or substance abuse test; - Smoking more than 5 per day within 6 months prior to enroll.
  • - Chronic overdose of tea, coffee, or caffeinated beverages within 3 months (average more than 8 cups per day, 1 cup=250mL);having any food or beverages with alcohol / caffeine within 48 hours prior to administration (such as coffee, strong tea, cocoa, chocolate and so on); having any food or beverages with rich grapefruit, grapefruit juice or others effect on absorption distribution, metabolism, excretion; - insufficient understanding of the content and unwilling to comply with arrangement and other sides do not meet the inclusion criteria.
- Any other conditions, the subject was inappropriate to participate in the study by investigators evaluated (for example, weak or having a disease that prevents the subjects from completing the study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04367441
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate to Severe Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 608

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

Placebo Comparator: Placebo

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

Interventions

Drug: - 608

recombinant humanized anti-IL17A monoclonal antibody injection

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Public Health Clinical Center (Shanghai), Jinshan, Shanghai, China

Status

Recruiting

Address

Public Health Clinical Center (Shanghai)

Jinshan, Shanghai, 201508

Site Contact

Hongzhou Lu, PHD

luhongzhou@fudan.edu.cn

(021)37990333-5278

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