IPFPhase 1NCT06310746
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects
A Phase 1 study testing GARP/TGF-β1 monoclonal antibody in people with IPF, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF
- What is being tested?
- GARP/TGF-β1 monoclonal antibody
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2024to 30 Jul 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully informed about the nature, significance, potential inconveniences, and associated risks of the study prior to enrollment. Comprehend the study's procedures and methodology, agree to follow the clinical study protocol, and give voluntary written informed consent;
- 18-55 years old, including the boundary value, male or female;
- Body weight: 45-85 kg for females and 50-85 kg for males, including the boundary value; body mass index (BMI): 18.0-28.0 kg/m2 , including the boundary value, (BMI = body weight (kg)/body height2 (m2));
- Subjects, including males, must have no childbearing plan and take effective contraceptive measures from the time of informed consent to 6 months after the administration of the study drug.
- Physical examinations and vital signs should be normal or abnormal without clinical significance.
Who cannot join
- Any clinically significant laboratory test abnormalities or, within 12 months before screening, any other clinically significant clinical findings indicative of diseases, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular conditions;
- Donation/loss of ≥ 450 mL of blood or receipt of blood transfusion or use of blood products within 3 months prior to screening, or planning to donate blood during the study or within 1 month after the end of the study;
- Patients with severe trauma or major surgery within 3 months before screening, or planning to undergo surgery during the study;
- Patients who smoke more than 5 cigarettes per day in the 3 months before screening;
- History of drug abuse or addiction or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.
This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product.
- Conditions
- IPF
- Being tested
- GARP/TGF-β1 monoclonal antibody, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GARP/TGF-β1 monoclonal antibodyDrug
It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg).
PlaceboDrug
It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| HLX6018 | Experimental | Not described Receives: Drug: GARP/TGF-β1 monoclonal antibody |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs)
Safety evaluation
Measured: 0 to Day 99
Secondary outcomes (6)
AUC0-inf
Area under the serum concentration-time curve
Measured: 0 to Day 99
Cmax
Peak concentration
Measured: 0 to Day 99
Tmax
Time to reach peak concentration
Measured: 0 to Day 99
T1/2
Terminal elimination half-life
Measured: 0 to Day 99
CL
Clearance
Measured: 0 to Day 99
λz
Terminal elimination rate constant
Measured: 0 to Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start23 Apr 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310746
- Sponsor's protocol ID
- HLX6018-FIH101
- Status last verified
- Sep 2025
- First submitted
- 7 Mar 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06310746
- Acronym / sponsor ID
- HLX6018-FIH101
- Conditions
- IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Mar 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.
The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.
This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX6018 | Experimental | Drug: GARP/TGF-β1 monoclonal antibody |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fully informed about the nature, significance, potential inconveniences, and associated risks of the study prior to enrollment. Comprehend the study's procedures and methodology, agree to follow the clinical study protocol, and give voluntary written informed consent;
- 18-55 years old, including the boundary value, male or female;
- Body weight: 45-85 kg for females and 50-85 kg for males, including the boundary value; body mass index (BMI): 18.0-28.0 kg/m2 , including the boundary value, (BMI = body weight (kg)/body height2 (m2));
- Subjects, including males, must have no childbearing plan and take effective contraceptive measures from the time of informed consent to 6 months after the administration of the study drug.
- Physical examinations and vital signs should be normal or abnormal without clinical significance.
Key exclusion criteria (5 listed)
- Any clinically significant laboratory test abnormalities or, within 12 months before screening, any other clinically significant clinical findings indicative of diseases, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular conditions;
- Donation/loss of ≥ 450 mL of blood or receipt of blood transfusion or use of blood products within 3 months prior to screening, or planning to donate blood during the study or within 1 month after the end of the study;
- Patients with severe trauma or major surgery within 3 months before screening, or planning to undergo surgery during the study;
- Patients who smoke more than 5 cigarettes per day in the 3 months before screening;
- History of drug abuse or addiction or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
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 |
|---|---|---|
| GARP/TGF-β1 monoclonal antibodyIt is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). | Drug | HLX6018 |
| PlaceboIt is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). | Drug | Placebo |
Primary outcome
The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs)
Time frame: 0 to Day 99
Safety evaluation
6 secondary outcomes
AUC0-inf
Time frame: 0 to Day 99
Cmax
Time frame: 0 to Day 99
Tmax
Time frame: 0 to Day 99
T1/2
Time frame: 0 to Day 99
CL
Time frame: 0 to Day 99
λz
Time frame: 0 to Day 99
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 19 Sep 2025.
- Individual participant dataSharing planned: No
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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 GARP/TGF-β1 monoclonal antibody in people with IPF, run by Shanghai Henlius Biotech 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 5 inclusion and 5 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 19 Sep 2025. 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. Some participants in this study may receive a placebo. 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?
The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs) (time frame: 0 to Day 99). 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 19 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.