AzTrials
AzTrials

OsteoporosisPhase 1NCT03870100

The PK/PD Study of A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

A Phase 1 study testing SHR-1222 in people with Osteoporosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Single Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects. Read more about this study

Who is it for?
Ages 45 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Osteoporosis
What is being tested?
SHR-1222
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteChina
Study dates
15 Apr 2019to 6 Jan 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 45 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Signed informed consent;
  • Male or postmenopausal female;
  • Age ≥45 and ≤59 years old;
  • The body mass index (BMI) ≥18.5kg/m2 and ≤28 kg/m2;
  • T value of areal bone mineral density on any lumbar spine (L1-L4) or collum femoris>-2.5 and <-1;
  • The comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication;
  • No smoking, alcohol or drugs abuse.

Who cannot join

  • Any disease affecting bone metabolism;
  • Past medical history of cerebral infarction or cerebral arterial thrombosis;
  • Past medical history of myocardial infarction;
  • Administration of the following drugs within 6m: Hormone replacement therapy, Calcitonin Parathyroid hormone (or any derivative), Supplemental Vitamin D>1,000 IU/day, Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics;
  • Administration of the following drugs within 12m: Bisphosphonates, Fluoride for osteoporosis;
  • A bone fracture within the previous 6 months;
Show all 18Show fewer
  • A lumbar spine L1-L4 or femoral neck T-score ≤-2.5;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 1.5 x ULN during screening;
  • 3 months prior to screening involved in any drug clinical subjects;
  • Subjects determined by the researchers have any food, dietary supplement or drugs that affect SHR-1222 absorption, distribution, metabolism and excretion in 4 weeks prior to screening or within 5 half-lives;
  • Serious infection, trauma or major surgery in 4 weeks prior to screening;
  • A surgery plan during the study;
  • Blood donation and transfusion in 3 months prior to screening;
  • Unstable thyroid dysfunction in 6 months prior to screening;
  • Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
  • Intolerant to venous blood collection;
  • A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar
  • Subjects with any other situation should not be involved, which determined by the researchers.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 2nd Xiangya Hospital of Central South University

    Changsha

Other trials in China

About this study

Official title: Use the Protocol Title. The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study Following A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects

This is a Single Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics with A Single Subcutaneous Injection of SHR-1222 in Healthy Subjects.

The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in healthy subjects. Secondary objectives are to determine the pharmacokinetics (PK) and pharmacodynamics(PD) profile of SHR-1222 in healthy subjects including assessment of immunogenicity.

Read the detailed description

50 adult healthy subjects with 5 dose groups will be enrolled in the study, including six subjects in the lowest dose group, four of whom received the SHR-1209 and two of whom received the placebo. The other three groups have 11 subjects in each group, 9 administered SHR-1222 and 2 administered placebo. The primary endpoint is the Safety and Tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Conditions
Osteoporosis
Being tested
SHR-1222, Placebo
Medical subject headings
Osteoporosis

What participants receive

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

  • SHR-1222Drug

    Pharmaceutical form: water injection Route of administration: subcutaneous

  • PlaceboDrug

    Pharmaceutical form: water injection Route of administration: subcutaneous

Study groups in NCT03870100
Study groupRoleWhat they receive
Cohort 1ExperimentalA single subcutaneous injection of SHR-1222 dose 1 versus placebo
Receives: Drug: SHR-1222; Drug: Placebo
Cohort 2ExperimentalA single subcutaneous injection of SHR-1222 dose 2 versus placebo
Receives: Drug: SHR-1222; Drug: Placebo
Cohort 3ExperimentalA single subcutaneous injection of SHR-1222 dose 3 versus placebo
Receives: Drug: SHR-1222; Drug: Placebo
Cohort 4ExperimentalA single subcutaneous injection of SHR-1222 dose 4 versus placebo
Receives: Drug: SHR-1222; Drug: Placebo
Cohort 5ExperimentalA single subcutaneous injection of SHR-1222 dose 5 versus placebo
Receives: Drug: SHR-1222; Drug: Placebo

What is being measured

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

  1. Number & proportion of subjects with adverse events [Time Frame: dose administration to 85 days after dose administration] Safety and Tolerance: Number & proportion of subjects with adverse events

    Measured: Dose administration to 85 days after dose administration

Secondary outcomes (12)

  1. Assessment of PK parameter-time to maximum concentration (Tmax)

    Measured: Pre-dose to 85 days after dose administration

  2. Assessment of PK parameter-maximum concentration (Cmax)

    Measured: Pre-dose to 85 days after dose administration

  3. Assessment of PK parameter-area under curve (AUC)

    Measured: Pre-dose to 85 days after dose administration

  4. Assessment of PD parameter-change in serum C-telopeptide (sCTx) from baseline

    Measured: Pre-dose to 85 days after dose administration

  5. Assessment of PD parameter-change in aminoterminal propeptide type-1 procollagen (P1NP) from baseline

    Measured: Pre-dose to 85 days after dose administration

  6. Assessment of PD parameter-change in osteocalcin from baseline

    Measured: Pre-dose to 85 days after dose administration

  7. Assessment of PD parameter-change in bone-specific alkaline phosphatase (BSAP) from baseline

    Measured: Pre-dose to 85 days after dose administration

  8. Assessment of PD parameter-change in areal bone mineral density of lumbar spine (L1-L4 mean T value) from baseline

    by dualenergy X-ray absorptiometry

    Measured: Pre-dose to 85 days after dose administration

  9. Assessment of PD parameter-change in areal bone mineral density of collum femoris (T value) from baseline

    by dualenergy X-ray absorptiometry

    Measured: Pre-dose to 85 days after dose administration

  10. Assessment of PD parameter-change in volumetric bone mineral density of lumbar spine (L1-L4 mean T value) from baseline

    by quantitative computed tomography

    Measured: Pre-dose to 85 days after dose administration

  11. Assessment of PD parameter-change in volumetric bone mineral density of collum femoris (T value) from baseline

    by quantitative computed tomography

    Measured: Pre-dose to 85 days after dose administration

  12. Antidrug antibody concentration

    Measured: Pre-dose to 85 days after dose administration

Timeline

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

  1. First posted11 Mar 2019
  2. Study start15 Apr 2019
  3. Primary completion14 Oct 2019
  4. Study completion6 Jan 2020

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03870100
Sponsor's protocol ID
SHR-1222-101
Status last verified
Jun 2020
First submitted
25 Feb 2019
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dai Z, Fang P, Yan X, Zhu R, Feng Q, Yan Q, Yang L, Fan X, Xie Y, Zhuang L, Feng S, Liu Y, Zhong S, Yang Z, Sheng Z, Zhou Z. Single Dose of SHR-1222, a Sclerostin Monoclonal Antibody, in Healthy Men and Postmenopausal Women With Low Bone Mass: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase I Study. Front Pharmacol. 2021 Oct 20;12:770073. doi: 10.3389/fphar.2021.770073. eCollection 2021.

    PubMed 34744750

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1222 in people with Osteoporosis, run by Jiangsu HengRui Medicine 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 16 Jun 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number & proportion of subjects with adverse events [Time Frame: dose administration to 85 days after dose administration] Safety and Tolerance: Number & proportion of subjects with adverse events (time frame: Dose administration to 85 days after dose administration). 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 NCT03870100, which also lists 1 linked publication.

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 16 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in