ARDS (Acute Respiratory Distress Syndrome)Phase 1NCT07449572
Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 for Treating ARDS
A Phase 1 study testing HT31-1 and Saline (0.9%, sterile, for infusion) in people with ARDS (Acute Respiratory Distress Syndrome), run by HTIC, Inc at 2 sites in United States.
Trial summary
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- HT31-1 and Saline (0.9%, sterile, for infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Age 18 to 65 years old, inclusive, at the time of consent.
- Able and willing to provide written informed consent and to comply with all study procedures and requirements.
- Healthy as determined by medical history, physical examination, and baseline investigations. No clinically significant abnormalities on physical exam.
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m², inclusive.
- Vital signs and 12-lead ECG without clinically significant abnormalities, in the investigator's judgment, at screening (e.g., resting blood pressure and heart rate within normal limits).
Show all 10Show fewer
- Screening clinical laboratory tests (hematology, chemistry, liver and kidney function, etc.) within normal ranges or not clinically significant as judged by the investigator.
- Female volunteers must be of non-childbearing potential (either surgically sterile by tubal ligation, bilateral oophorectomy or hysterectomy at least 6 months prior, or postmenopausal for ≥1 year) OR if of childbearing potential must agree to use 2 approved effective contraceptions from screening through at least 90 days after the last dose. Acceptable methods include hormonal contraception, intrauterine device, or barrier methods with spermicide.
- Male volunteers with partners of childbearing potential must agree to use 2 approved effective contraception (e.g., condom plus spermicide) from screening through 90 days after their dose of study drug.
- Able to communicate well with the investigator and comply with study requirements (e.g., availability for all follow-up visits).
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- History of any severe allergy or hypersensitivity to drugs, or known hypersensitivity to any monoclonal antibody (including prior biologic therapy reactions).
- Known autoimmune disease or immunodeficiency condition, including a positive test for HIV at screening.
- Active or chronic viral hepatitis infection: positive screening test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody.
- History of tetanus infection, or receipt of tetanus toxoid vaccine within 6 months prior to first dose of study drug. (Rationale: CitH3 is associated with NETs, and recent tetanus immunization may confound immune status or antibody responses).
- Receipt of any live attenuated vaccine within 4 weeks prior to first dose, or any inactivated vaccine within 2 weeks prior to first dose. (This is to avoid confounding immune activation or risk to the volunteer's health).
Show all 19Show fewer
- History of any significant acute or chronic illness that, in the investigator's opinion, could interfere with the trial or pose additional risk in administering the investigational drug. Examples include significant cardiovascular, hepatic, renal, gastrointestinal, hematologic, neurologic, psychiatric, or respiratory conditions that are not well-controlled.
- Recent major surgery (within 3 months prior to screening) or planned elective surgery during the study period. (Minor outpatient procedures are allowed at the investigator's discretion.)
- Difficulty with venous access or an inability to tolerate blood draws, such that required PK sampling would be compromised.
- History of drug or alcohol abuse: positive urine drug screen at screening for illicit substances, or a history of significant drug abuse in the past 5 years. Regular use of cannabis is also exclusionary unless stopped prior to study.
- Positive screening alcohol breath test, or history of excessive alcohol intake (more than ~14 units per week; 1 unit = 360 mL beer, 150 mL wine, or 45 mL of 40% spirit) within 6 months. Any indication of alcoholism or inability to refrain from alcohol during study participation.
- Use of any prescription or over-the-counter medications, herbal remedies, or supplements within 14 days prior to first dose, except hormonal contraceptives or occasional acetaminophen. (Any necessary medications may be reviewed by the investigator for approval if unlikely to interfere with study outcomes).
- Participation in another clinical trial of an investigational drug or device within 4 weeks (or 5 half-lives of that investigational product, whichever is longer) prior to dosing.
- Donation of >400 mL of blood (or significant blood loss of similar volume) within 3 months prior to screening, or donation of >200 mL within 1 month prior. (This is to avoid anemia or confounding volume loss).
- Receipt of any blood products or immunoglobulin therapy within 90 days before dosing.
- Chronic use of immunosuppressive medications (systemic corticosteroids, immunomodulators) within 45 days before dosing (inhaled/topical steroids for mild conditions may be permitted).
- Regular use of nicotine products (smoking more than 5 cigarettes per day or equivalent) within 3 months prior to screening, or inability to refrain from tobacco/nicotine during the study.
- Pregnant or breastfeeding women. (Female volunteers must have a negative pregnancy test and not be nursing.)
- Any other condition that, in the opinion of the investigator, makes the volunteer unsuitable for study participation (e.g. inability to comply with protocol, or any factor that would jeopardize the volunteer's safety or the validity of the data).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Virginia Commonwealth University (VCU Health)
Richmond, Virginia, 23298
Lacey Harris, MPH, BSN, 804-828-0404, Lacey.Harris@vcuhealth.org
- Recruiting
Virginia Commonwealth University (VCU Health)
Richmond, Virginia, 23298
Lacey Harris, MPH, BSN, 804-828-0404, Lacey.Harris@vcuhealth.org
About this study
Official title: A Phase 1/2A, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 (hCitH3-mAb) in Healthy Volunteers and in Patients With Mild-to-Moderate ARDS: Part A (Healthy Volunteers)
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source.
The current trial (Part A) focuses on single ascending doses (SAD) in healthy volunteers to characterize the safety profile, PK parameters, and immunogenicity of HT31-1. Emerging data from this phase will inform dose selection for the subsequent Part B study in ARDS patients and help establish the recommended Phase 2 dose (RP2D). Additionally, exploratory pharmacodynamic and biomarker assessments will be performed to evaluate target engagement and potential early biological activity.
Read the detailed description
HT31-1 injection is a first-in-class humanized monoclonal antibody that neutralizes citrullinated histone H3 (CitH3), a critical damage-associated molecular pattern (DAMP) driving neutrophil extracellular trap (NETosis-induced endothelial injury, microvascular thrombosis, and hyper-inflammation in sepsis and ARDS. HT31-1 addresses the underlying pathophysiology of sepsis/ARDS without impacting the innate immune defense function, thus provide a potentially safe and effective means to treat ARDS.
Design: Randomized, double-blind, placebo-controlled, single ascending dose (SAD) study.
Cohort size: 8 participants per cohort (6 assigned to HT31-1 and 2 assigned to placebo).
Randomization: 3:1 ratio (HT31-1: placebo). Blinding: HT31-1 and placebo will be provided as identical, indistinguishable investigational products supplied by the Investigational Pharmacy. Both participants and all study site personnel (including investigators, study staff, and safety assessors) will remain blinded to treatment allocation. Randomization codes will be maintained by an independent statistician or designated unblinded party and will not be disclosed until database lock unless required for subject safety.
Population: Approximately 24 healthy adult volunteers.
Dosing:
A single intravenous infusion of HT31-1 per cohort at ascending dose levels of 1 mg/kg, 5 mg/kg, and 20 mg/kg. Dose escalation will proceed in a sentinel dosing format with interim safety reviews between cohorts.
Each cohort will enroll 8 participants (6 HT31-1, 2 placebo). A total of up to 24 participants will be enrolled in Part A. No additional expansion cohort is planned.
- Being tested
- HT31-1, Saline (0.9%, sterile, for infusion)
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Single Ascending Dose, Monoclonal Antibody
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HT31-1Drug
Also called hCitH3-mAb, humanized anti-citrullinated histone H3 monoclonal antibody
HT-1 is a humanized monoclonal antibody developed by HTIC, Inc as a treatment for Acute Respiratory Distress Syndrome (ARDS) Due to an Infectious Source
Saline (0.9%, sterile, for infusion)Other
Also called Placebo control
Saline is as placebo control
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 1 mg/kg | Experimental | HT31-1 1mg/kg single intravenous dosing Receives: Drug: HT31-1 |
| Cohort 1: Placebo | Placebo comparator | Saline single intravenous dosing Receives: Other: Saline (0.9%, sterile, for infusion) |
| Cohort 2: 5 mg/kg | Experimental | HT31-1 5mg/kg single intravenous dosing Receives: Drug: HT31-1 |
| Cohort 2: Placebo | Placebo comparator | Saline single intravenous dosing Receives: Other: Saline (0.9%, sterile, for infusion) |
| Cohort 3: 20 mg/kg | Experimental | HT31-1 20mg/kg single intravenous dosing Receives: Drug: HT31-1 |
| Cohort 3: Placebo | Placebo comparator | Saline single intravenous dosing Receives: Other: Saline (0.9%, sterile, for infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following administration of HT31-1.
Measured: 0-28 days
Assess dose-limiting toxicities (DLTs)
Number and percentage of participants experiencing DLTs at each dose level.
Measured: 0-28 days
Secondary outcomes (7)
Maximum observed concentration (Cmax)
Maximum observed plasma concentration (Cmax) of HT31-1 following single intravenous administration.
Measured: From pre-dose through Day 28 post-dose
Time to maximum concentration (Tmax)
Time to reach the maximum observed plasma concentration (Tmax) of HT31-1 following single intravenous administration.
Measured: From pre-dose through Day 28 post-dose
Area under the curve (AUC)
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t )and from time zero extrapolated to infinity (AUC0-∞) of HT31-1 following single intravenous administration.
Measured: From pre-dose through Day 28 post-dose
Half-life (t1/2)
Time for serum concentration to decrease by half in the terminal phase.
Measured: From pre-dose through Day 28 post-dose
Clearance (CL)
Volume of plasma cleared of drug per unit time (mL/hr or L/day).
Measured: From pre-dose through Day 28 post-dose
Volume of distribution (Vd)
Volume of distribution (Vd) of HT31-1 following single intravenous administration.
Measured: From pre-dose through Day 28 post-dose
Assess preliminary pharmacodynamic (PD) effects
Measurable changes in circulating CitH3 levels following either HT31-1 or placebo administration.
Measured: From pre-dose through Day 28 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start28 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HTIC, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianjie Ma, PhD, Study director, HTIC, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449572
- Sponsor's protocol ID
- PROT-CR-CP25101
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is an early-phase study with a small number of participants, and sharing data could risk participant re-identification.
Publications
Weber M, Chen Y, Zhou X, Chun H, Wu D, Park KH, Cai C, Li Y, Ma J, Yang Z. Humanized Monoclonal Antibody Against Citrullinated Histone H3 Attenuates Myocardial Injury and Prevents Heart Failure in Rodent Models. Biomolecules. 2025 Aug 20;15(8):1196. doi: 10.3390/biom15081196.
PubMed 40867640Ouyang W, Chen Y, Tan T, Song Y, Dong T, Yu X, Lee KE, Zhou X, Tetz Z, Go S, Zeng X, Shao L, Quan C, Zhao T, Tian Y, Kurabayashi K, Jin H, Ma J, Qin J, Williams B, Li Q, Zhu GD, Alam HB, Stringer KA, Li Y, Ma J. A citrullinated histone H3 monoclonal antibody for immune modulation in sepsis. Nat Commun. 2025 Aug 12;16(1):7435. doi: 10.1038/s41467-025-62788-6.
PubMed 40796783Aziz DZ, Binion CC, Xu H, Wang X, Rodgers S, Gillis DC, Ledford BT, Siletzky R, Zhou X, Li Y, Cai C, Tsihlis ND, Ma J, Kibbe MR. Humanized Citrullinated Histone H3 Monoclonal Antibody Improves Respiratory Function and Attenuates Neutrophil-Mediated Inflammation in a Rodent Model of Smoke Inhalation Lung Injury. J Am Coll Surg. 2026 Jan 1;242(1):1-12. doi: 10.1097/XCS.0000000000001620. Epub 2025 Dec 17.
PubMed 41051091
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2A, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HT31-1 (hCitH3-mAb) in Healthy Volunteers and in Patients With Mild-to-Moderate ARDS: Part A (Healthy Volunteers)
- ClinicalTrials.gov ID
- NCT07449572
- Acronym / sponsor ID
- PROT-CR-CP25101
- Keywords
- Acute Respiratory Distress Syndrome (ARDS), Single Ascending Dose, Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- HTIC, IncIndustry (pharma, biotech, devices)
- Study start
- 28 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 4 Mar 2026 (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.
This Phase 1/2A, randomized, double-blind study will evaluate the safety, tolerability, and pharmacokinetics (PK) of HT31-1 (hCitH3-mAb) in healthy adult volunteers and in patients with mild-to-moderate acute respiratory distress syndrome (ARDS) due to an infectious source.
The current trial (Part A) focuses on single ascending doses (SAD) in healthy volunteers to characterize the safety profile, PK parameters, and immunogenicity of HT31-1. Emerging data from this phase will inform dose selection for the subsequent Part B study in ARDS patients and help establish the recommended Phase 2 dose (RP2D). Additionally, exploratory pharmacodynamic and biomarker assessments will be performed to evaluate target engagement and potential early biological activity.
Detailed description
HT31-1 injection is a first-in-class humanized monoclonal antibody that neutralizes citrullinated histone H3 (CitH3), a critical damage-associated molecular pattern (DAMP) driving neutrophil extracellular trap (NETosis-induced endothelial injury, microvascular thrombosis, and hyper-inflammation in sepsis and ARDS. HT31-1 addresses the underlying pathophysiology of sepsis/ARDS without impacting the innate immune defense function, thus provide a potentially safe and effective means to treat ARDS.
Design: Randomized, double-blind, placebo-controlled, single ascending dose (SAD) study.
Cohort size: 8 participants per cohort (6 assigned to HT31-1 and 2 assigned to placebo).
Randomization: 3:1 ratio (HT31-1: placebo). Blinding: HT31-1 and placebo will be provided as identical, indistinguishable investigational products supplied by the Investigational Pharmacy. Both participants and all study site personnel (including investigators, study staff, and safety assessors) will remain blinded to treatment allocation. Randomization codes will be maintained by an independent statistician or designated unblinded party and will not be disclosed until database lock unless required for subject safety.
Population: Approximately 24 healthy adult volunteers.
Dosing:
A single intravenous infusion of HT31-1 per cohort at ascending dose levels of 1 mg/kg, 5 mg/kg, and 20 mg/kg. Dose escalation will proceed in a sentinel dosing format with interim safety reviews between cohorts.
Each cohort will enroll 8 participants (6 HT31-1, 2 placebo). A total of up to 24 participants will be enrolled in Part A. No additional expansion cohort is planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 1 mg/kg | Experimental | Drug: HT31-1HT31-1 1mg/kg single intravenous dosing |
| Cohort 1: Placebo | Placebo comparator | Other: Saline (0.9%, sterile, for infusion)Saline single intravenous dosing |
| Cohort 2: 5 mg/kg | Experimental | Drug: HT31-1HT31-1 5mg/kg single intravenous dosing |
| Cohort 2: Placebo | Placebo comparator | Other: Saline (0.9%, sterile, for infusion)Saline single intravenous dosing |
| Cohort 3: 20 mg/kg | Experimental | Drug: HT31-1HT31-1 20mg/kg single intravenous dosing |
| Cohort 3: Placebo | Placebo comparator | Other: Saline (0.9%, sterile, for infusion)Saline single intravenous dosing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 65 years old, inclusive, at the time of consent.
- Able and willing to provide written informed consent and to comply with all study procedures and requirements.
- Healthy as determined by medical history, physical examination, and baseline investigations. No clinically significant abnormalities on physical exam.
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m², inclusive.
- Vital signs and 12-lead ECG without clinically significant abnormalities, in the investigator's judgment, at screening (e.g., resting blood pressure and heart rate within normal limits).
Key exclusion criteria (19 listed)
- History of any severe allergy or hypersensitivity to drugs, or known hypersensitivity to any monoclonal antibody (including prior biologic therapy reactions).
- Known autoimmune disease or immunodeficiency condition, including a positive test for HIV at screening.
- Active or chronic viral hepatitis infection: positive screening test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody.
- History of tetanus infection, or receipt of tetanus toxoid vaccine within 6 months prior to first dose of study drug. (Rationale: CitH3 is associated with NETs, and recent tetanus immunization may confound immune status or antibody responses).
- Receipt of any live attenuated vaccine within 4 weeks prior to first dose, or any inactivated vaccine within 2 weeks prior to first dose. (This is to avoid confounding immune activation or risk to the volunteer's health).
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 |
|---|---|---|
| HT31-1Also: hCitH3-mAb, humanized anti-citrullinated histone H3 monoclonal antibodyHT-1 is a humanized monoclonal antibody developed by HTIC, Inc as a treatment for Acute Respiratory Distress Syndrome (ARDS) Due to an Infectious Source | Drug | Cohort 1: 1 mg/kg, Cohort 2: 5 mg/kg, Cohort 3: 20 mg/kg |
| Saline (0.9%, sterile, for infusion)Also: Placebo controlSaline is as placebo control | Other | Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 0-28 days
The number and percentage of participants experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following administration of HT31-1.
Assess dose-limiting toxicities (DLTs)
Time frame: 0-28 days
Number and percentage of participants experiencing DLTs at each dose level.
7 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: From pre-dose through Day 28 post-dose
Time to maximum concentration (Tmax)
Time frame: From pre-dose through Day 28 post-dose
Area under the curve (AUC)
Time frame: From pre-dose through Day 28 post-dose
Half-life (t1/2)
Time frame: From pre-dose through Day 28 post-dose
Clearance (CL)
Time frame: From pre-dose through Day 28 post-dose
Volume of distribution (Vd)
Time frame: From pre-dose through Day 28 post-dose
Assess preliminary pharmacodynamic (PD) effects
Time frame: From pre-dose through Day 28 post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 40867640Weber M, Chen Y, Zhou X, Chun H, Wu D, Park KH, Cai C, Li Y, Ma J, Yang Z. Humanized Monoclonal Antibody Against Citrullinated Histone H3 Attenuates Myocardial Injury and Prevents Heart Failure in Rodent Models. Biomolecules. 2025 Aug 20;15(8):1196. doi: 10.3390/biom15081196.
- Background: PubMed 40796783Ouyang W, Chen Y, Tan T, Song Y, Dong T, Yu X, Lee KE, Zhou X, Tetz Z, Go S, Zeng X, Shao L, Quan C, Zhao T, Tian Y, Kurabayashi K, Jin H, Ma J, Qin J, Williams B, Li Q, Zhu GD, Alam HB, Stringer KA, Li Y, Ma J. A citrullinated histone H3 monoclonal antibody for immune modulation in sepsis. Nat Commun. 2025 Aug 12;16(1):7435. doi: 10.1038/s41467-025-62788-6.
- Background: PubMed 41051091Aziz DZ, Binion CC, Xu H, Wang X, Rodgers S, Gillis DC, Ledford BT, Siletzky R, Zhou X, Li Y, Cai C, Tsihlis ND, Ma J, Kibbe MR. Humanized Citrullinated Histone H3 Monoclonal Antibody Improves Respiratory Function and Attenuates Neutrophil-Mediated Inflammation in a Rodent Model of Smoke Inhalation Lung Injury. J Am Coll Surg. 2026 Jan 1;242(1):1-12. doi: 10.1097/XCS.0000000000001620. Epub 2025 Dec 17.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is an early-phase study with a small number of participants, and sharing data could risk participant re-identification.
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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.
Jianjie Ma, PhD study director
HTIC, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HT31-1 and Saline (0.9%, sterile, for infusion) in people with ARDS (Acute Respiratory Distress Syndrome), run by HTIC, Inc at 2 sites 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 10 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lacey Harris, MPH, BSN (804-828-0404, Lacey.Harris@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 0-28 days). The study lists 2 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 NCT07449572, which also lists 3 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 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.