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

April 25, 2020 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Jinshan, Shanghai, China, 201508
        • Recruiting
        • Public Health Clinical Center (Shanghai)
        • Contact:
          • Hongzhou Lu, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 608
8mg, 20mg, 40mg, 80mg, 120mg, 160mg, 200mg
Drug: 608
recombinant humanized anti-IL17A monoclonal antibody injection
PLACEBO_COMPARATOR: Placebo
20mg, 40mg, 80mg, 120mg, 160mg, 200mg
Drug: Placebo
auxiliary material of 608 include histidine, histidine hydrochloride, sucrose and polysorbate 80

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: From baseline through 71days/91day
Maximum observed concentration (Cmax) of 608
From baseline through 71days/91day
Tmax
Time Frame: From baseline through 71days/91day
Time to Reach the Maximum Concentration After Drug Administration (Tmax) in 608 group
From baseline through 71days/91day
AUClast
Time Frame: From baseline through 71days/91day
Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast) in 608 group.
From baseline through 71days/91day
AUCinf
Time Frame: From baseline through 71days/91day
Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in 608 group.
From baseline through 71days/91day
CL
Time Frame: From baseline through 71days/91day
Systemic Clearance From Serum Following Intravenous Administration (CL) in 608 group
From baseline through 71days/91day
Vd
Time Frame: From baseline through 71days/91day
Apparent volume of distribution (Vd) in 608 group
From baseline through 71days/91day
T1/2
Time Frame: From baseline through 71days/91day
Terminal Elimination Half-life (T1/2) in 608 group
From baseline through 71days/91day
MRT
Time Frame: From baseline through 71days/91day
Mean residence time (MRT) in 608 group
From baseline through 71days/91day
λz
Time Frame: From baseline through 71days/91day
Apparent terminal elimination rate constant (λz)in 608 group.
From baseline through 71days/91day
Percentage of Participants With Anti-608 Antibodies
Time Frame: From baseline through 71days/91day.
Percentage of participants with treatment-emergent positive anti-608 antibodies and Neutralizing antibody;
From baseline through 71days/91day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSGJ -608- Psoriasis-I-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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