ImmunologyPhase 1NCT07390747
A Trial of SHR-2173 in Healthy Volunteers
A Phase 1 study of Immunology, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunology
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Mar 2026to 28 Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Main inclusion criteria
- Healthy white participants.
- Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- Male aged between 18 to 45 years of age (inclusive)
- Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
- Men and WOCBP must agree to take highly effective contraceptive methods
Main exclusion Criteria
- History or evidence of clinically significant disorders.
- Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study or same class drug or any component of it.
- Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
- The injection site has abnormalities or is deemed by the investigator as unsuitable for subcutaneous injection.
- History of excessive smoking in the past 1 month prior to screening
- History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
- Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Subcutaneous Administration of SHR-2173 in Healthy Participants
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants
- Conditions
- Immunology
- Being tested
- SHR-2173 Injection/SHR-2173 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2173 Injection/SHR-2173 placeboDrug
Single dose SHR-2173 injection or matching placebo given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| SHR-2173 single dose | Experimental | Single dose of SHR-2173/ given subcutaneously Receives: Drug: SHR-2173 Injection/SHR-2173 placebo |
| SHR-2173 placebo single dose | Experimental | Single dose of SHR-2173/placebo given subcutaneously Receives: Drug: SHR-2173 Injection/SHR-2173 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Cmax
Maximum observed plasma concentration (Cmax)
Measured: Day 71
Pharmacokinetics - AUC₀-t
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Measured: Day 71
Pharmacokinetics - AUC₀-inf
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Measured: Day 71
Pharmacokinetics - Tmax
Time to reach maximum observed plasma concentration (Tmax)
Measured: Day 71
Pharmacokinetics - t½
Terminal elimination half-life (t½)
Measured: Day 71
Immunogenicity - Anti-Drug Antibody (ADA)
Incidence and onset time of anti-drug antibody (ADA)
Measured: Day 71
Secondary outcomes (1)
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Measured: Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start6 Mar 2026
- Primary completion22 May 2026
- Study completion28 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunologyStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- Single dose of SHR-2173 will be administered subcutaneously
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390747
- Sponsor's protocol ID
- SHR-2173-106
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 14 Oct 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Subcutaneous Administration of SHR-2173 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07390747
- Acronym / sponsor ID
- SHR-2173-106
- Conditions
- Immunology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 5 Feb 2026 (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.
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single dose of SHR-2173 will be administered subcutaneously
| Arm | Type | Receives |
|---|---|---|
| SHR-2173 single dose | Experimental | Drug: SHR-2173 Injection/SHR-2173 placeboSingle dose of SHR-2173/ given subcutaneously |
| SHR-2173 placebo single dose | Experimental | Drug: SHR-2173 Injection/SHR-2173 placeboSingle dose of SHR-2173/placebo given subcutaneously |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-2173 Injection/SHR-2173 placeboSingle dose SHR-2173 injection or matching placebo given subcutaneously | Drug | SHR-2173 placebo single dose, SHR-2173 single dose |
Primary outcome
Pharmacokinetics - Cmax
Time frame: Day 71
Maximum observed plasma concentration (Cmax)
Pharmacokinetics - AUC₀-t
Time frame: Day 71
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Pharmacokinetics - AUC₀-inf
Time frame: Day 71
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Pharmacokinetics - Tmax
Time frame: Day 71
Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetics - t½
Time frame: Day 71
Terminal elimination half-life (t½)
Immunogenicity - Anti-Drug Antibody (ADA)
Time frame: Day 71
Incidence and onset time of anti-drug antibody (ADA)
1 secondary outcome
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Time frame: Day 71
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 14 Oct 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 of Immunology, run by Atridia Pty Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Oct 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 Australia. 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?
Pharmacokinetics - Cmax (time frame: Day 71). The study lists 6 primary outcomes in all. 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 14 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.