HealthyPhase 1NCT04590430

Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults

A Phase 1 study testing HFB30132A in people with Healthy, run by HiFiBiO Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to test the safety and tolerability of HFB30132A when it is given by intravenously to healthy participants. Blood tests will be done to check how much HFB30132A is in the bloodstream and how long the body takes to eliminate it. Participation may include up to ten visits to the study center. 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: 24 participants
Where: 1 siteUnited States
Study dates: 20 Oct 2020to 26 Jul 2021
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 (both inclusive). 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 is confirmed as negative by SARS-CoV-2 RT-PCR testing on screening and prior to admission to the unit.
Subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures.
Willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including COVID-19 social distancing guidelines as described in Section 5.7.2 (under "Hygiene") from signing of informed consent through end of study on Day 180.
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.
Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit on Day 180. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (IUDs) at least 3 months prior to Screening or a vasectomized partner. Note: Complete abstinence from sexual intercourse is acceptable.

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Female subject is 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 (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit.
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 on Day 270. 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 on Day 180.

Who cannot join

History of any illness or history or presence of clinically significant pathology that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject or collecting samples for analysis. This includes, but is not limited to, a history of relevant drug or food allergies; history of clinically significant cardiovascular, pulmonary, autoimmune, psychiatric or central nervous system disease, or of cancer with systemic spread in remission for less than 5 years.
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 except for vitamin supplements, hormonal contraception, and recommended doses of acetaminophen, aspirin or ibuprofen
Hospitalization for any reason within 60 days 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). Subjects with positive hepatitis C virus (HCV) antibody at the screening visit are only eligible if they have previously completed treatment for HCV and have confirmatory negative test for HCV RNA.
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.
Participation (defined as receipt of dose of investigational agent) in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit

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Blood donation of approximately 1 pint (500 mL) within 60 days prior to dosing, or donation of more than 1 unit of plasma within 30 days prior to the start of study drug dosing
Receipt of any transfused blood products within 60 days of the screening visit.
Any history of receiving treatment or vaccination against SARS-CoV-2
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose First-in-Human Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered HFB30132A, a Monoclonal Antibody Directed Against SARS-CoV-2, in Healthy Adult Subjects

Read the detailed description

This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and dose escalation study in 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 24 hours after IMP administration, will be discharged on Day 2 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and
A Follow up Period lasting 180 days after the IMP dose. The study will be conducted at a single study center in Cincinnati.

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 and 3 will receive HFB30132A doses 2 and 3, respectively.
PlaceboOther
Participants randomized to placebo will receive the same volume of solution as participants on active treatment.

Study groups in NCT04590430
Study group	Role	What they receive
HFB30132A	Experimental	Participants will receive HFB30132A administered across 3 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 TEAEs
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Number of participants with treatment emergent adverse events (TEAE) of special interest
Safety and tolerability will be evaluated in terms of number of participants with TEAEs of special interest (hypersensitivity / anaphylactic reaction / local tolerability)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
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 of the last enrolled subject
Maximum observed serum concentration (Cmax)
Measured: From Day 1 to up to Day 30 of the last enrolled subject
Minimum observed serum concentration (Cmin)
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
Steady-state volume of distribution (Vss)
Measured: From Day 1 to up to Day 30 of the last enrolled subject

Secondary outcomes (10)

Number of participants with treatment-emergent adverse events (TEAEs)
Safety and tolerability will be evaluated in terms of number of participants with TEAEs
Measured: From Day 1 to up to last follow-up day (Day 180)
Number of participants with treatment-emergent serious adverse events (TESAEs)
Safety and tolerability will be evaluated in terms of number of participants with TESAEs
Measured: From Day 1 to up to last follow-up day (Day 180)
Maximum observed serum HFB30132A concentration (Cmax) in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 180)
Minimum observed serum HFB30132A concentration (Cmin) in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 180)
Time of maximum serum HFB30132A concentration (Tmax) in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 180)
Area under the concentration vs. time curve (AUC0-last), AUC0-∞) in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 180)
Terminal half-life (T1/2) of HFB30132A in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 190)
Systemic clearance (CL) of HFB30132A in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 180)
Steady-state volume of distribution (Vss) of HFB30132A in nasal and oral secretions
Measured: From Day 1 to up to last follow-up day (Day 180)
HFB30132A Anti-drug antibodies
Presence or absence of antibodies against HFB30132A over time
Measured: From Day 1 to up to last follow-up day (Day 180)

Timeline

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

20 Oct 202026 Jul 2021

First posted19 Oct 2020
Study start20 Oct 2020
Primary completion26 Jul 2021
Study completion26 Jul 2021

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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04590430
Sponsor's protocol ID: HFB30132A-101
Status last verified: Mar 2022
First submitted: 8 Oct 2020
Last updated: 11 Mar 2022
Results posted: No
Data monitoring committee: Yes
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 39793935
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose First-in-Human Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered HFB30132A, a Monoclonal Antibody Directed Against SARS-CoV-2, in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT04590430
Acronym / sponsor ID: HFB30132A-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: HiFiBiO TherapeuticsIndustry (pharma, biotech, devices)
Study start: 20 Oct 2020 (actual)
Primary completion: 26 Jul 2021 (actual)
Study completion: 26 Jul 2021 (actual)
First posted: 19 Oct 2020 (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.

Detailed description

This is a Phase I, first time in human, randomized, double-blind, placebo-controlled, and dose escalation study in 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 24 hours after IMP administration, will be discharged on Day 2 after all safety and/or pharmacokinetic (PK) evaluations have been completed, and
A Follow up Period lasting 180 days after the IMP dose. The study will be conducted at a single study center in Cincinnati.

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 3 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 (both inclusive). 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 is confirmed as negative by SARS-CoV-2 RT-PCR testing on screening and prior to admission to the unit.
Subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures.
Willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including COVID-19 social distancing guidelines as described in Section 5.7.2 (under "Hygiene") from signing of informed consent through end of study on Day 180.
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.

Key exclusion criteria (10 listed)

History of any illness or history or presence of clinically significant pathology that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject or collecting samples for analysis. This includes, but is not limited to, a history of relevant drug or food allergies; history of clinically significant cardiovascular, pulmonary, autoimmune, psychiatric or central nervous system disease, or of cancer with systemic spread in remission for less than 5 years.
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 except for vitamin supplements, hormonal contraception, and recommended doses of acetaminophen, aspirin or ibuprofen
Hospitalization for any reason within 60 days 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). Subjects with positive hepatitis C virus (HCV) antibody at the screening visit are only eligible if they have previously completed treatment for HCV and have confirmatory negative test for HCV RNA.
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.

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 and 3 will receive HFB30132A doses 2 and 3, respectively.	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 of the last enrolled subject
Number of participants experiencing TEAEs
Number of participants with treatment emergent adverse events (TEAE) of special interest
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Safety and tolerability will be evaluated in terms of number of participants with TEAEs of special interest (hypersensitivity / anaphylactic reaction / local tolerability)
Number of participants with treatment-emergent adverse events (TEAE)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Safety and tolerability will be evaluated in terms of number of participants with TEAE
Maximum observed serum concentration (Cmax)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject
Minimum observed serum concentration (Cmin)
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
Steady-state volume of distribution (Vss)
Time frame: From Day 1 to up to Day 30 of the last enrolled subject

10 secondary outcomes

Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: From Day 1 to up to last follow-up day (Day 180)
Number of participants with treatment-emergent serious adverse events (TESAEs)
Time frame: From Day 1 to up to last follow-up day (Day 180)
Maximum observed serum HFB30132A concentration (Cmax) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Minimum observed serum HFB30132A concentration (Cmin) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Time of maximum serum HFB30132A concentration (Tmax) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Area under the concentration vs. time curve (AUC0-last), AUC0-∞) in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Terminal half-life (T1/2) of HFB30132A in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 190)
Systemic clearance (CL) of HFB30132A in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
Steady-state volume of distribution (Vss) of HFB30132A in nasal and oral secretions
Time frame: From Day 1 to up to last follow-up day (Day 180)
HFB30132A Anti-drug antibodies
Time frame: From Day 1 to up to last follow-up day (Day 180)

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 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
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.

Leela Vrishabhendra, MD principal investigator

Medpace, Inc.

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 United States.

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 10 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 United States. 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 of the last enrolled subject). 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 NCT04590430, 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.