HealthyPhase 1NCT05942612

A Phase I Study of SHR -2001 in Healthy Subjects

A Phase 1 study testing SHR-2001 in people with Healthy, run by Guangdong Hengrui Pharmaceutical 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

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Trial summary

This study is a phase 1 single dose or multiple doses escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-2001 in healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: SHR-2001
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteChina
Study dates: 19 Jul 2023to 20 Nov 2024
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
Age 18 ~ 55 years old (including boundary value), male or female;
Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
Participants who are overtly healthy as determined by medical history and physical examination.;
Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.

Who cannot join

Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2001 After a Single or Multiple Subcutaneous Injections in Healthy Subjects

Conditions: Healthy
Being tested: SHR-2001, Placebo

What participants receive

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

SHR-2001Drug
Subcutaneous injection, single dose or multiple doses.
PlaceboDrug
Subcutaneous injection, single dose or multiple doses.

Study groups in NCT05942612
Study group	Role	What they receive
Cohort 1	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 2	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 3	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 4	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 5	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 6	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 7	Experimental	A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 8	Experimental	A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 9	Experimental	A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 10	Experimental	A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 11	Experimental	A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo
Cohort 12	Experimental	A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects. Receives: Drug: SHR-2001; Drug: Placebo

What is being measured

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

Adverse events
Incidence and severity of adverse events
Measured: Start of Treatment to end of study (approximately 64 days).

Secondary outcomes (8)

Pharmacokinetics-AUC0-t
Area under the concentration-time curve from 0 to the last measurable time point after SHR-2001 administration
Measured: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-2001 administration
Measured: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-2001
Measured: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Tmax
Time to Cmax
Measured: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-2001
Measured: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-CL/F
Apparent clearance of SHR-2001
Measured: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR-2001
Measured: Start of Treatment to end of study (approximately 64 days).
Anti-Drug antibody
The percentage of subjects with positive ADA
Measured: Start of Treatment to end of study (approximately 64 days).

Timeline

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

19 Jul 202320 Nov 2024

First posted12 Jul 2023
Study start19 Jul 2023
Primary completion20 Nov 2024
Study completion20 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05942612
Sponsor's protocol ID: SHR-2001-101
Status last verified: Jun 2025
First submitted: 4 Jul 2023
Last updated: 25 Jun 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2001 After a Single or Multiple Subcutaneous Injections in Healthy Subjects
ClinicalTrials.gov ID: NCT05942612
Acronym / sponsor ID: SHR-2001-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 19 Jul 2023 (actual)
Primary completion: 20 Nov 2024 (actual)
Study completion: 20 Nov 2024 (actual)
First posted: 12 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
Cohort 1	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects.
Cohort 2	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects.
Cohort 3	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects.
Cohort 4	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects.
Cohort 5	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects.
Cohort 6	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects.
Cohort 7	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects.
Cohort 8	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects.
Cohort 9	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects.
Cohort 10	Experimental	Drug: SHR-2001, Drug: PlaceboA single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects.
Cohort 11	Experimental	Drug: SHR-2001, Drug: PlaceboA multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects.
Cohort 12	Experimental	Drug: SHR-2001, Drug: PlaceboA multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol;
Age 18 ~ 55 years old (including boundary value), male or female;
Weight ≥ 45 kg, body mass index (BMI) ranging 19 ~ 28 kg/m2 (including boundary value);
Participants who are overtly healthy as determined by medical history and physical examination.;
Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.

Key exclusion criteria (3 listed)

Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks;
Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial;
Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHR-2001Subcutaneous injection, single dose or multiple doses.	Drug	Cohort 1, Cohort 10, Cohort 11, Cohort 12, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9
PlaceboSubcutaneous injection, single dose or multiple doses.	Drug	Cohort 1, Cohort 10, Cohort 11, Cohort 12, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9

Primary outcome

Adverse events
Time frame: Start of Treatment to end of study (approximately 64 days).
Incidence and severity of adverse events

8 secondary outcomes

Pharmacokinetics-AUC0-t
Time frame: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Cmax
Time frame: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Tmax
Time frame: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-t1/2
Time frame: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-CL/F
Time frame: Start of Treatment to end of study (approximately 64 days).
Pharmacokinetics-Vz/F
Time frame: Start of Treatment to end of study (approximately 64 days).
Anti-Drug antibody
Time frame: Start of Treatment to end of study (approximately 64 days).

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-2001 in people with Healthy, run by Guangdong Hengrui Pharmaceutical 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 3 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 25 Jun 2025. 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?

Adverse events (time frame: Start of Treatment to end of study (approximately 64 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 NCT05942612.

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 25 Jun 2025.