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Healthy ParticipantsPhase 1NCT07852325

Comparative Pharmacokinetics of SHR-8068 and Ipilimumab in Healthy Chinese Men

A Phase 1 study testing SHR-8068 and Ipilimumab in people with Healthy Participants, run by The Affiliated Hospital of Qingdao University 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 phase 1 study compared the pharmacokinetics of a single intravenous dose of SHR-8068 injection with ipilimumab (YERVOY®) in healthy Chinese men. Safety and immunogenicity were also evaluated. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
SHR-8068 and Ipilimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteChina
Study dates
7 Jan 2024to 19 Dec 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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provides written informed consent and is willing and able to comply with all protocol requirements.
  • Healthy male, 18 to 45 years of age, inclusive, on the date of informed consent.
  • Body weight 50 to 80 kg, inclusive, and body mass index 19.0 to 26.0 kg/m², inclusive.
  • Has no reproductive plans during the study and for 3 months after the last dose; agrees to use effective contraception and not donate sperm during this period.

Who cannot join

  • History of autoimmune disease.
  • History of malignancy, except successfully resected cutaneous squamous cell carcinoma, basal cell carcinoma, or localized cervical carcinoma in situ without evidence of metastasis.
  • Positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody, or Treponema pallidum antibody.
  • Known history of recurrent or chronic infection, including but not limited to chronic renal infection, chronic chest infection such as bronchiectasis, sinusitis, recurrent urinary tract infection, or an open, draining, or infected skin wound.
  • Acute infection within 2 weeks before screening.
  • Opportunistic infection within 6 months before screening, including herpes zoster or active cytomegalovirus, Pneumocystis, Histoplasma, Aspergillus, or mycobacterial infection.
Show all 20Show fewer
  • Known history of tuberculosis, clinical findings suspicious for tuberculosis, or a positive tuberculosis laboratory test.
  • History of chronic or serious disease, or current disease, involving the respiratory, cardiovascular, digestive, urinary, hematologic, endocrine, immune, neurologic, or psychiatric systems, or otherwise considered unsuitable by the investigator.
  • Allergic constitution, including a history of severe drug allergy or hypersensitivity, a definite allergy history, or allergy to either study drug or its components; untreated asymptomatic seasonal allergy or an isolated positive skin test is not exclusionary.
  • Any surgery within 6 months before screening or planned surgery during the study.
  • Blood loss or donation of at least 400 mL within 3 months before screening, or at least 200 mL within 1 month before screening, or receipt of a blood transfusion within 3 months before screening.
  • Clinically significant abnormality in physical examination, vital signs, laboratory tests, 12-lead electrocardiogram, abdominal ultrasonography, or chest radiography during screening.
  • History of illicit drug use or drug abuse within 1 year before screening, or a positive drug screen.
  • Habitual alcohol or tobacco use (an average of at least 14 units of alcohol per week within 6 months before screening, where 1 unit equals 285 mL beer, 25 mL spirits, or 100 mL wine; or an average of at least 5 cigarettes per day) and inability to abstain during the study.
  • Previous use of ipilimumab or an ipilimumab biosimilar.
  • Use of any medication within 2 weeks before the first study dose or within 5 half-lives of the medication, whichever is longer, or planned use of other medication during the study, including prescription or nonprescription drugs, Chinese herbal medicines, and dietary supplements.
  • Participation in a drug or medical-device clinical trial within 3 months before screening, ongoing follow-up in another clinical study, or exposure within 5 half-lives of the prior investigational drug, whichever is longer.
  • Receipt of a live vaccine within 6 months before screening or planned receipt of a live vaccine during the study.
  • History of needle or blood phobia, difficult blood collection, or inability to tolerate venipuncture.
  • Any other factor considered by the investigator to make participation unsuitable, or withdrawal for the participant's own reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

Other trials in China

About this study

Official title: A Single-Dose, Randomized, Double-Blind, Single-Period, Parallel Clinical Study Comparing the Pharmacokinetics of SHR-8068 Injection and Ipilimumab (YERVOY®) in Healthy Chinese Male Participants

This phase 1 study compared the pharmacokinetics of a single intravenous dose of SHR-8068 injection with ipilimumab (YERVOY®) in healthy Chinese men. Safety and immunogenicity were also evaluated.

Read the detailed description

The study comprised an open-label pilot stage and a double-blind formal stage. In the pilot stage, 12 healthy Chinese men were randomized in parallel to receive a single 0.3 mg/kg intravenous infusion of SHR-8068 (n=6) or ipilimumab (n=6). The pilot evaluated safety, pharmacokinetic characteristics and variability, and immunogenicity, and informed optimization of pharmacokinetic and immunogenicity sampling for the formal stage.

In the formal stage, 112 healthy Chinese men were randomized in a 1:1 ratio, under double-blind conditions, to receive a single 0.3 mg/kg intravenous infusion of SHR-8068 (n=56) or ipilimumab (n=56) in a single-period, parallel design. The primary pharmacokinetic parameters were maximum serum concentration (Cmax) and area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-inf). Other pharmacokinetic parameters, safety, and immunogenicity were also evaluated. Formal-stage pharmacokinetic equivalence was assessed using the 90% confidence intervals for the geometric mean ratios of Cmax and AUC0-inf, with prespecified limits of 80.00% to 125.00%.

Being tested
SHR-8068, Ipilimumab
Keywords
Pharmacokinetics

What participants receive

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

  • SHR-8068Biological

    SHR-8068 injection, 0.3 mg/kg, administered once by intravenous infusion over 30 ± 10 minutes.

  • IpilimumabBiological

    Ipilimumab injection (YERVOY®), 0.3 mg/kg, administered once by intravenous infusion over 30 ± 10 minutes.

Study groups in NCT07852325
Study groupRoleWhat they receive
SHR-8068ExperimentalParticipants received a single 0.3 mg/kg intravenous infusion of SHR-8068 injection over 30 ± 10 minutes. This arm included 6 participants in the open-label pilot stage and 56 participants in the double-blind formal stage.
Receives: Biological: SHR-8068
Ipilimumab (YERVOY®)Active comparatorParticipants received a single 0.3 mg/kg intravenous infusion of ipilimumab (YERVOY®) over 30 ± 10 minutes. This arm included 6 participants in the open-label pilot stage and 56 participants in the double-blind formal stage.
Receives: Biological: Ipilimumab

What is being measured

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

  1. Maximum Serum Concentration (Cmax)

    Cmax of SHR-8068 and ipilimumab in the formal study. Pharmacokinetic equivalence was assessed using the 90% confidence interval for the geometric mean ratio (SHR-8068/ipilimumab), with prespecified limits of 80.00% to 125.00%.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

  2. Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)

    AUC0-inf of SHR-8068 and ipilimumab in the formal study. Pharmacokinetic equivalence was assessed using the 90% confidence interval for the geometric mean ratio (SHR-8068/ipilimumab), with prespecified limits of 80.00% to 125.00%.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

Secondary outcomes (7)

  1. Area Under the Serum Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)

    AUC0-t of SHR-8068 and ipilimumab in the formal study.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

  2. Number of Participants With Adverse Events and Serious Adverse Events

    Incidence and severity of adverse events and serious adverse events after a single intravenous dose of SHR-8068 or ipilimumab.

    Measured: From dosing through Day 78

  3. Number of Participants With Anti-Drug Antibodies

    Anti-drug antibodies against SHR-8068 or ipilimumab were assessed in serum.

    Measured: Predose and Days 15, 36, and 57 after dosing

  4. Time to Maximum Serum Concentration (Tmax)

    Tmax of SHR-8068 and ipilimumab in the formal study.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

  5. Terminal Elimination Half-Life (t1/2)

    Terminal elimination half-life (t1/2) of SHR-8068 and ipilimumab in the formal study.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

  6. Clearance (CL)

    Clearance (CL) of SHR-8068 and ipilimumab in the formal study.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

  7. Volume of Distribution at Steady State (Vss)

    Volume of distribution at steady state (Vss) of SHR-8068 and ipilimumab in the formal study.

    Measured: From start of infusion through 1344 hours (Day 57) after dosing

Timeline

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

  1. First posted1 Oct 2026
  2. Study start7 Jan 2024
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

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
Model description
The study had two stages with the same two parallel intervention groups: an open-label pilot stage (12 participants) followed by a double-blind formal stage (112 participants).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852325
Sponsor's protocol ID
SHR-8068-103
Other IDs
CTR20234186
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-8068 and Ipilimumab in people with Healthy Participants, run by The Affiliated Hospital of Qingdao University 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 4 inclusion and 20 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 1 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 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?

Maximum Serum Concentration (Cmax) (time frame: From start of infusion through 1344 hours (Day 57) after dosing). The study lists 2 primary outcomes in all. 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 NCT07852325.

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 1 Oct 2026.

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