AzTrials
AzTrials

HIV-1 InfectionPhase 1NCT04802811

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects

A Phase 1 study of HIV-1 Infection, 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

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150. will consist of 50 healthy subjects, 5 groups. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
HIV-1 Infection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteChina
Study dates
22 Mar 2021to 10 Nov 2021
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

  • Signed informed consent.
  • Aged 18~45.
  • Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m2 ( Including boundary value) .
  • Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
  • Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.

Who cannot join

  • Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
  • Have severe infection, severe trauma or major surgical operations within 3 months. Plan to receive surgery during the trial and within two weeks after the end of the trial..
  • 12-ECG test have clinical significant abnormality or the QT interval (QTc) > 450 ms(male)/QTc)> 460 ms(male) or<300ms(female).
  • Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV)
  • Suspected allergy to any ingredient in the study drug.
  • Have any drug that inhibits or induces liver metabolism within 1 month.
Show all 16Show fewer
  • Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug judged by the investigator;
  • Treatment with immunosuppressant or interferon-containing drugs within 6 months of study drug administration;
  • Participated in clinical trials of any drug or medical device within 3 months before screening, or within 5 half-lives before screening;
  • Treatment with live(attenuated) vaccine within 2 months before taking the study drug or during the study or within 1 months after administration;
  • Had donated blood or blood transfusion≥ 200 mL within 1 months before taking the study drug or had donated blood or blood transfusion≥ 400 mL within 3 months prior to screening;
  • The average daily smoking ≥ 5 cigarettes within three months; the average daily alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol);
  • Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the study; and those who have special dietary requirements and cannot follow the unified diet;
  • History of drug abuse , drug dependence or drug screening test is positive;
  • Pregnant or lactating women;
  • Other conditions that the investigator believes the subject is not suitable.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing youan Hospital,Capital medical university

    Beijing, Beijing Municipality, 10069

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics of Oral SHR2150 in Healthy Subjects With Single Dose of SHR2150 in Healthy Subjects

The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150.

will consist of 50 healthy subjects, 5 groups. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.

Conditions
HIV-1 Infection
Being tested
SHR2150；Placebo

What participants receive

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

  • SHR2150；PlaceboDrug

    Single dose；SHR2150-dose 1 or Placebo-dose 1

  • SHR2150；PlaceboDrug

    Single dose；SHR2150-dose 2 or Placebo-dose 2

  • SHR2150；PlaceboDrug

    Single dose；SHR2150-dose 3 or Placebo-dose 3

  • SHR2150；PlaceboDrug

    Single dose；SHR2150-dose 4 or Placebo-dose 4

  • SHR2150；PlaceboDrug

    Single dose；SHR2150-dose 5 or Placebo-dose 5

Study groups in NCT04802811
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: SHR2150；Placebo
Treatment group BExperimentalNot described
Receives: Drug: SHR2150；Placebo
Treatment group CExperimentalNot described
Receives: Drug: SHR2150；Placebo
Treatment group DExperimentalNot described
Receives: Drug: SHR2150；Placebo
Treatment group EExperimentalNot described
Receives: Drug: SHR2150；Placebo

What is being measured

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

  1. The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0.

    Measured: 9 DAYS for Group A.B.C.D.E

Secondary outcomes (10)

  1. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[AUC0-last]

    The area under the concentration-time curve from time zero (pre-dose) to last time.

    Measured: Up to 96hours

  2. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [AUC0-∞]

    The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.

    Measured: Up to 96hours

  3. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[t1/2]

    Terminal Half-life

    Measured: Up to 96hours

  4. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma： [Tmax]

    Time to Maximum Observed Concentration

    Measured: Up to 96hours

  5. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Cmax]

    Maximum Observed Plasma Concentration

    Measured: Up to 96hours

  6. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [CL/F]

    Apparent clearance

    Measured: Up to 96hours

  7. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Vz/F]

    Apparent volume of distribution

    Measured: Up to 96hours

  8. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [MRT]

    Mean retention time

    Measured: Up to 96hours

  9. Pharmacodynamics: Changes in Cytokines in Serum: interferon γ-inducible protein-10

    Measured: Up to 48hhours

  10. Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α

    Measured: Up to 48hours

Timeline

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

  1. First posted17 Mar 2021
  2. Study start22 Mar 2021
  3. Primary completion10 Nov 2021
  4. Study completion10 Nov 2021

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04802811
Sponsor's protocol ID
SHR2150-I-103
Status last verified
Mar 2021
First submitted
10 Mar 2021
Last updated
28 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of HIV-1 Infection, 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 5 inclusion and 16 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 28 Dec 2021. 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?

The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0. (time frame: 9 DAYS for Group A.B.C.D.E). 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 NCT04802811.

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 28 Dec 2021.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT04802811 | AzTrials