Heart FailurePhase 1NCT06700083
A Safety, Tolerability, Pharmacokinetic Study of SHR-6934 Injection in Healthy Subjects
A Phase 1 study testing SHR-6934 injection in people with Heart Failure, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- SHR-6934 injection
- 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
- 6 Jan 2025to 10 May 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- Male or female aged 18-60;
- Females must have a negative pregnancy test at the Screening Visit;
- Body mass index (BMI) between 19 and 28 kg/m2;
- Normal Electrocardiogram (ECG);
- Men and women of childbearing potential must agree to take effective contraceptive methods.
Who cannot join
- History of any clinically important disease or disorder;
- History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug;
- Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris;
- Systolic blood pressure (SBP)≥140 mmHg or <90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or <60 mmHg;
- Patients with orthostatic hypotension;
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Single and Multiple Subcutaneous Injections of SHR-6934 in Healthy Subjects: a Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Trial
This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
- Conditions
- Heart Failure
- Being tested
- SHR-6934 injection, SHR-6934 placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-6934 injectionDrug
SHR-6934 injection
SHR-6934 placeboDrug
SHR-6934 placebo
| Study group | Role | What they receive |
|---|---|---|
| SAD dose 1 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| SAD dose 2 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| SAD dose 3 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| SAD dose 4 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| SAD dose 5 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| SAD dose 6 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| MAD dose 1 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| MAD dose 2 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| MAD dose 3 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
| MAD dose 4 | Experimental | Not described Receives: Drug: SHR-6934 injection; Drug: SHR-6934 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects with adverse events (AEs)
Measured: Baseline up to 113 days after the last dosing
Secondary outcomes (9)
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934
Measured: Baseline up to 113 days after the last dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934
Measured: Baseline up to 113 days after the last dosing
Maximum plasma concentration (Cmax) for SHR-6934
Measured: Baseline up to 113 days after the last dosing
Time to reach maximum plasma concentration (Tmax) for SHR-6934
Measured: Baseline up to 113 days after the last dosing
Terminal half-life (t1/2) for SHR-6934
Measured: Baseline up to 113 days after the last dosing
Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously
Measured: Baseline up to 113 days after the last dosing
Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously
Measured: Baseline up to 113 days after the last dosing
Proportion of anti-drug antibodies (ADA) positive subjects
Measured: Baseline up to 113 days after the last dosing
Baseline and placebo-adjusted QTcF after SHR-6934
Measured: Baseline up to 15 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start6 Jan 2025
- Primary completion10 May 2026
- Study completion10 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals 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)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700083
- Sponsor's protocol ID
- SHR-6934-101
- Status last verified
- May 2026
- First submitted
- 19 Nov 2024
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Single and Multiple Subcutaneous Injections of SHR-6934 in Healthy Subjects: a Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Trial
- ClinicalTrials.gov ID
- NCT06700083
- Acronym / sponsor ID
- SHR-6934-101
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 May 2026 (actual)
- First posted
- 21 Nov 2024 (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.
This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| SAD dose 1 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| SAD dose 2 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| SAD dose 3 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| SAD dose 4 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| SAD dose 5 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| SAD dose 6 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| MAD dose 1 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| MAD dose 2 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| MAD dose 3 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
| MAD dose 4 | Experimental | Drug: SHR-6934 injection, Drug: SHR-6934 placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- Male or female aged 18-60;
- Females must have a negative pregnancy test at the Screening Visit;
- Body mass index (BMI) between 19 and 28 kg/m2;
- Normal Electrocardiogram (ECG);
Key exclusion criteria (6 listed)
- History of any clinically important disease or disorder;
- History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug;
- Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris;
- Systolic blood pressure (SBP)≥140 mmHg or <90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or <60 mmHg;
- Patients with orthostatic hypotension;
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-6934 injectionSHR-6934 injection | Drug | MAD dose 1, MAD dose 2, MAD dose 3, MAD dose 4, SAD dose 1, SAD dose 2, SAD dose 3, SAD dose 4, SAD dose 5, SAD dose 6 |
| SHR-6934 placeboSHR-6934 placebo | Drug | MAD dose 1, MAD dose 2, MAD dose 3, MAD dose 4, SAD dose 1, SAD dose 2, SAD dose 3, SAD dose 4, SAD dose 5, SAD dose 6 |
Primary outcome
Incidence of subjects with adverse events (AEs)
Time frame: Baseline up to 113 days after the last dosing
9 secondary outcomes
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Maximum plasma concentration (Cmax) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Time to reach maximum plasma concentration (Tmax) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Terminal half-life (t1/2) for SHR-6934
Time frame: Baseline up to 113 days after the last dosing
Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously
Time frame: Baseline up to 113 days after the last dosing
Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously
Time frame: Baseline up to 113 days after the last dosing
Proportion of anti-drug antibodies (ADA) positive subjects
Time frame: Baseline up to 113 days after the last dosing
Baseline and placebo-adjusted QTcF after SHR-6934
Time frame: Baseline up to 15 days after dosing
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 28 May 2026.
- 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-6934 injection in people with Heart Failure, run by Beijing Suncadia Pharmaceuticals 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 6 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 May 2026. 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?
Incidence of subjects with adverse events (AEs) (time frame: Baseline up to 113 days after the last dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.