HealthyPhase 1NCT05275660
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults
A Phase 1 study testing HFB30132A in people with Healthy, run by HiFiBiO Therapeutics at 1 site in China.
Trial summary
The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HFB30132A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2021to 22 Feb 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy male or female subject, aged between 18 to 60 years (inclusive). A Body Mass Index (BMI) of between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a body weight of ≥45 kg for female, ≥50 kg for male.
- Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration.
- Subject voluntarily has given written informed and is willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception
- Female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. All female subjects must have a negative result for the pregnancy tests performed at screening and admission.
- For female subjects of childbearing potential: must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit
- Female subject of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal.
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- Male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from Study Day -1 (beginning of confinement) until 3 months after the final Follow-up Visit. Note: complete abstinence from sexual intercourse is acceptable.
- Male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last Follow-up Visit.
- Subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures.
Who cannot join
- History or symptoms of any clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, pulmonary, hematological, autoimmune, psychiatric disease, metabolic disorder.
- History of pulmonary tuberculosis and clinically significant abnormal chest CT results
- History of drug or alcohol abuse within 1 year prior to screening, or positive test for drugs of potential abuse at screening and admission, where alcohol abuse is defined as regular consumption exceeding 7 drinks/ week for women, and 14 drinks/ week for men.
- Use of any medications started within 14 days (or 5 half-lives, whichever is longer) prior to study drug administration including, prescription medications, nutritional supplements, and over-the-counter medications
- Blood donation of approximately 500 mL within 60 days prior to dosing, or donation of more than 200 mL within 30 days, or receipt of any transfused blood products within 60 days prior to the screening visit
- Receipt of treatment or vaccination against SARS-CoV-2 within 90 days prior to dosing, or planning for vaccination against SARS-CoV-2 from screening to 90 days after dosing
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- Receipt of influenza vaccination within 4 weeks before screening or planning to receive influenza vaccination from screening to 90 days after dosing
- Symptoms of acute respiratory tract infection within 28 days before dosing
- Febrile illness within 28 days prior to the first dose of study drug, or other signs or symptoms consistent with SARS-CoV-2 infection in the judgement of the Investigator in the 14 days prior to the first dose of study drug.
- Hospitalization for any reason within 60 days prior to the screening visit
- Participation (defined as receipt of dose of investigational agent) in any clinical research study evaluating another investigational drug or therapy within 3 months prior to the screening visit
- History of or positive human immunodeficiency virus (HIV) screen result, or positive blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) or subjects with positive hepatitis C virus (HCV) antibody.
- Subject is confirmed as positive by SARS-CoV-2 RT-PCR or antibody testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety, Tolerability, and Pharmacokinetics of Single Dose Intravenously Administered HFB30132A, a Monoclonal Antibody Against SARS-CoV-2, in Chinese Healthy Adult Subjects
The purpose of this study is to examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
Read the detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese healthy volunteers.
The study will comprise of:
- A Screening Period of up to 30 days (Day -30 through Day -1);
- A Treatment Period during which participants will be resident at the Observation Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 48 hours (Day 3) after IMP administration. Participants will be discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and
- A Follow up Period lasting 270 days after the IMP dose.
- Conditions
- Healthy
- Being tested
- HFB30132A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFB30132ADrug
Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 will receive HFB30132A dose 2.
PlaceboOther
Participants randomized to placebo will receive the same volume of solution as participants on active treatment.
| Study group | Role | What they receive |
|---|---|---|
| HFB30132A | Experimental | Participants will receive HFB30132A administered across 2 fixed-dose cohorts via intravenous infusions (to be administered sequentially) Receives: Drug: HFB30132A |
| Placebo | Placebo comparator | Placebo will be administered to participants across three fixed-dose cohorts similar to the active treatment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent serious adverse events (TESAEs)
Number of participants experiencing TESAEs
Measured: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants with treatment emergent adverse events of special interest (TEAESI)
Safety and tolerability will be evaluated in terms of number of participants with TEAESI (hypersensitivity / anaphylactic reaction / local tolerability)
Measured: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants with treatment-emergent adverse events (TEAE)
Safety and tolerability will be evaluated in terms of number of participants with TEAE
Measured: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants with changes in laboratory values, vital signs and ECG parameters
Safety and tolerability will be evaluated in terms of number of participants with changes in laboratory values, vital signs and ECG parameters
Measured: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Maximum observed serum concentration (Cmax)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Time of maximum serum concentration (Tmax)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Area under the concentration vs. time curve (AUC0-last), AUC0-∞)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Terminal half-life (T1/2)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Systemic clearance (CL)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Apparent volume of distribution (Vd)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start9 May 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiFiBiO Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275660
- Sponsor's protocol ID
- GCSW-XGAB-Ⅰ01
- Status last verified
- Feb 2022
- First submitted
- 10 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Li S, Hedrich W, Wu X, Li S, Qiu C, Lin K, Bian X, He J, Zhou H, Adrian F, Schweizer L, Zhang J. Population pharmacokinetics and pharmacodynamics of HFB30132A, a monoclonal antibody against SARS-CoV-2, in healthy Chinese and US subjects. Int J Antimicrob Agents. 2025 Mar;65(3):107439. doi: 10.1016/j.ijantimicag.2024.107439. Epub 2025 Jan 9.
PubMed 39793935Li S, Wu X, Li N, Cao G, Wang J, Chen Y, Li S, He J, Wu J, Yang H, Lin K, Qiu C, Liu A, Zhou H, Adrian F, Schweizer L, Zhang W, Gu J, Zhang J. Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study. Front Pharmacol. 2023 May 23;14:1117293. doi: 10.3389/fphar.2023.1117293. eCollection 2023.
PubMed 37332355
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety, Tolerability, and Pharmacokinetics of Single Dose Intravenously Administered HFB30132A, a Monoclonal Antibody Against SARS-CoV-2, in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05275660
- Acronym / sponsor ID
- GCSW-XGAB-Ⅰ01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HiFiBiO TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 11 Mar 2022 (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 examine the safety and tolerability of HFB30132A when it is given by single intravenous infusion in Chinese healthy participants.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study in Chinese healthy volunteers.
The study will comprise of:
- A Screening Period of up to 30 days (Day -30 through Day -1);
- A Treatment Period during which participants will be resident at the Observation Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 48 hours (Day 3) after IMP administration. Participants will be discharged on Day 3 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and
- A Follow up Period lasting 270 days after the IMP dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFB30132A | Experimental | Drug: HFB30132AParticipants will receive HFB30132A administered across 2 fixed-dose cohorts via intravenous infusions (to be administered sequentially) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be administered to participants across three fixed-dose cohorts similar to the active treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject is a healthy male or female subject, aged between 18 to 60 years (inclusive). A Body Mass Index (BMI) of between 18 to 30 kilograms per square meter (kg/m^2) inclusive, and a body weight of ≥45 kg for female, ≥50 kg for male.
- Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration.
- Subject voluntarily has given written informed and is willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception
- Female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. All female subjects must have a negative result for the pregnancy tests performed at screening and admission.
- For female subjects of childbearing potential: must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit
Key exclusion criteria (13 listed)
- History or symptoms of any clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, pulmonary, hematological, autoimmune, psychiatric disease, metabolic disorder.
- History of pulmonary tuberculosis and clinically significant abnormal chest CT results
- History of drug or alcohol abuse within 1 year prior to screening, or positive test for drugs of potential abuse at screening and admission, where alcohol abuse is defined as regular consumption exceeding 7 drinks/ week for women, and 14 drinks/ week for men.
- Use of any medications started within 14 days (or 5 half-lives, whichever is longer) prior to study drug administration including, prescription medications, nutritional supplements, and over-the-counter medications
- Blood donation of approximately 500 mL within 60 days prior to dosing, or donation of more than 200 mL within 30 days, or receipt of any transfused blood products within 60 days prior to the screening visit
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 |
|---|---|---|
| HFB30132AParticipants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 will receive HFB30132A dose 2. | Drug | HFB30132A |
| PlaceboParticipants randomized to placebo will receive the same volume of solution as participants on active treatment. | Other | Placebo |
Primary outcome
Number of participants with treatment emergent serious adverse events (TESAEs)
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Number of participants experiencing TESAEs
Number of participants with treatment emergent adverse events of special interest (TEAESI)
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Safety and tolerability will be evaluated in terms of number of participants with TEAESI (hypersensitivity / anaphylactic reaction / local tolerability)
Number of participants with treatment-emergent adverse events (TEAE)
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Safety and tolerability will be evaluated in terms of number of participants with TEAE
Number of participants with changes in laboratory values, vital signs and ECG parameters
Time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A
Safety and tolerability will be evaluated in terms of number of participants with changes in laboratory values, vital signs and ECG parameters
Maximum observed serum concentration (Cmax)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Time of maximum serum concentration (Tmax)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Area under the concentration vs. time curve (AUC0-last), AUC0-∞)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Terminal half-life (T1/2)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Systemic clearance (CL)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Apparent volume of distribution (Vd)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
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 11 Mar 2022.
- Derived from this study: PubMed 39793935Chen Y, Li S, Hedrich W, Wu X, Li S, Qiu C, Lin K, Bian X, He J, Zhou H, Adrian F, Schweizer L, Zhang J. Population pharmacokinetics and pharmacodynamics of HFB30132A, a monoclonal antibody against SARS-CoV-2, in healthy Chinese and US subjects. Int J Antimicrob Agents. 2025 Mar;65(3):107439. doi: 10.1016/j.ijantimicag.2024.107439. Epub 2025 Jan 9.
- Derived from this study: PubMed 37332355Li S, Wu X, Li N, Cao G, Wang J, Chen Y, Li S, He J, Wu J, Yang H, Lin K, Qiu C, Liu A, Zhou H, Adrian F, Schweizer L, Zhang W, Gu J, Zhang J. Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study. Front Pharmacol. 2023 May 23;14:1117293. doi: 10.3389/fphar.2023.1117293. eCollection 2023.
- 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 HFB30132A in people with Healthy, run by HiFiBiO Therapeutics 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 9 inclusion and 13 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 11 Mar 2022. 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?
Number of participants with treatment emergent serious adverse events (TESAEs) (time frame: From Day 1 to up to Day 30 after the single dose administration of HFB30132A). The study lists 10 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 NCT05275660, which also lists 2 linked publications.
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 11 Mar 2022.