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Moderate to Severe Plaque PsoriasisPhase 1NCT04367441

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

A Phase 1 study testing 608 in people with Moderate to Severe Plaque Psoriasis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Moderate to Severe Plaque Psoriasis
What is being tested?
608
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteChina
Study dates
25 Nov 2019to 31 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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 locations and contacts

1 site in 1 country.

Hongzhou Lu, PhD contact

(021)37990333-5278

luhongzhou@fudan.edu.cn

China1 site, 1 recruiting

  • Public Health Clinical Center (Shanghai)

    Jinshan, Shanghai Municipality, 201508

    Hongzhou Lu, PHD

    Hongzhou LU

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
608, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 608Drug

    recombinant humanized anti-IL17A monoclonal antibody injection

  • PlaceboDrug

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

Study groups in NCT04367441
Study groupRoleWhat they receive
608Experimental8mg, 20mg, 40mg, 80mg, 120mg, 160mg, 200mg
Receives: Drug: 608
PlaceboPlacebo comparator20mg, 40mg, 80mg, 120mg, 160mg, 200mg
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE/SAEs

    Incidence of treatment emergent AE/SAEs

    Measured: 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)

  1. Cmax

    Maximum observed concentration (Cmax) of 608

    Measured: From baseline through 71days/91day

  2. Tmax

    Time to Reach the Maximum Concentration After Drug Administration (Tmax) in 608 group

    Measured: From baseline through 71days/91day

  3. AUClast

    Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast) in 608 group.

    Measured: From baseline through 71days/91day

  4. AUCinf

    Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in 608 group.

    Measured: From baseline through 71days/91day

  5. CL

    Systemic Clearance From Serum Following Intravenous Administration (CL) in 608 group

    Measured: From baseline through 71days/91day

  6. Vd

    Apparent volume of distribution (Vd) in 608 group

    Measured: From baseline through 71days/91day

  7. T1/2

    Terminal Elimination Half-life (T1/2) in 608 group

    Measured: From baseline through 71days/91day

  8. MRT

    Mean residence time (MRT) in 608 group

    Measured: From baseline through 71days/91day

  9. λz

    Apparent terminal elimination rate constant (λz)in 608 group.

    Measured: From baseline through 71days/91day

  10. Percentage of Participants With Anti-608 Antibodies

    Percentage of participants with treatment-emergent positive anti-608 antibodies and Neutralizing antibody;

    Measured: From baseline through 71days/91day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2020
  2. Study start25 Nov 2019
  3. Primary completion31 Oct 2020 (estimated)
  4. Study completion31 Oct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04367441
Sponsor's protocol ID
SSGJ -608- Psoriasis-I-01
Status last verified
Apr 2020
First submitted
25 Apr 2020
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 608 in people with Moderate to Severe Plaque Psoriasis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongzhou Lu, PhD ((021)37990333-5278, luhongzhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04367441.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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