A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
NCT07479576
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Start date
2025-11-10
Number of sites
- Summary
- This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®（Guselkumab） in healthy subjects after a single dose.
- Short title
- A Comparative Phase 1 Study to Evaluate the Pharmacokinetic and Safety of QL2106 vs Tremfye® in Healthy Subjects
- Official title
- A Randomized, Double-blinded, Parallel, Positive-controlled Study to Compare the Pharmacokinetic, Safety and Immunogenicity of Single-dose QL2106 vs Tremfye® in Healthy Subjects
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-04-23
- First posted
- 2026-03-18
- Registry last updated
- 2026-08-05
- Primary completion date
- 2026-04-23
- Start date
- 2025-11-10
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07479576
- ClinicalTrials.gov ID
- NCT07479576
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
Pharmacokinetics Endpoint
Timeframe: 0-113 days
Peak plasma concentration (Cmax)
Pharmacokinetics Endpoint
Timeframe: 0-113 days
Area under the plasma concentration versus time curve (AUC0-inf)
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- Healthy subjects aged from 18 to 45 years (including the boundary value)；
- BMI between 19-26 kg/m2 (including boundary value) and body weight between 50-90 kg (including boundary value);
- Normal results of physical examination/laboratory examination/ECG or abnormal with no clinical significance according to the PI's judgment;
- The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 3 months after the completion of the drug administration and voluntarily adopts effective contraceptive measures;
- Sign the informed consent before joining the study, and fully understand the content, process and possible risks.
- History of allergic reactions or hypersensitivity to Guselkumab, other IL-23 biologics or excipients;
- Alcoholics，or subjects who consumed more than 14 units of alcohol per week in the 6 months before screening;
- Those who had lost blood or donated at least 400 mL in the 3 months prior to screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial；
- Those who smoked more than 5 cigarettes per day in the 3 months before screening;
- Drug users in the 5 years prior to screening, or positive urine drug screening；
- Having used Guselkumab (or its biosimilars) or interleukin (IL-23) targeting agents;
- Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study;
- Use of any prescription drug, over-the-counter drug or health product within 14 days prior to screening
- Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive;
- Other conditions considered inappropriate to be included in this study.
Sources for eligibility
- Beijing GoBroad HospitalBeijing, China
Sources for sites