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

NCT07852325 | Completed Phase 1

• 2 other identifiers: SHR-8068-103CTR20234186
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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%.

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

• 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%.

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

Secondary Outcomes (7)

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

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

• Number of Participants With Adverse Events and Serious Adverse Events

  From dosing through Day 78

• Number of Participants With Anti-Drug Antibodies

  Predose and Days 15, 36, and 57 after dosing

• Time to Maximum Serum Concentration (Tmax)

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

• Terminal Elimination Half-Life (t1/2)

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

Study Arms (2)

SHR-8068

EXPERIMENTAL

Participants 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.

Biological: SHR-8068

Ipilimumab (YERVOY®)

ACTIVE COMPARATOR

Participants 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.

Biological: Ipilimumab

Interventions

SHR-8068 BIOLOGICAL

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

SHR-8068

Ipilimumab BIOLOGICAL

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

Ipilimumab (YERVOY®)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: collaborator
• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The pilot stage was open-label. In the formal stage, participants, investigators, outcome evaluators, data management personnel, and statisticians remained blinded; designated unblinded staff prepared study treatment when required.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: October 1, 2026
• Study Start: January 7, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)