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HIV AntibodiesPhase 1VRC 609NCT03538626

Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

A Phase 1 study testing VRC-HIVMAB091-00-AB and rHuPH20 in people with HIV Antibodies, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

Background: The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same. N6LS is directed against the HIV virus. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Antibodies
What is being tested?
VRC-HIVMAB091-00-AB and rHuPH20
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
21 Jun 2018to 29 Aug 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A volunteer must have met all of the following criteria:
  • Willing and able to complete the informed consent process.
  • 18 to 50 years of age.
  • Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria.
  • Willing to have blood samples collected, stored indefinitely, and used for research purposes.
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
Show all 18Show fewer
  • Screening laboratory criteria within 84 days prior to enrollment meeting the following criteria:
  • White blood cell count (WBC): 2,500-12,000/mm^3.
  • WBC differential: Within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval.
  • Platelets: 125,000-400,000/mm^3.
  • Hemoglobin: Within institutional normal range or accompanied by PI or designee approval.
  • Creatinine: less than or equal to 1.1 x Upper Limit of Normal (ULN).
  • Alanine aminotransferase (ALT): less than or equal to 1.25 x ULN.
  • Aspartate aminotransferase (AST): less than or equal to 1.25 x ULN.
  • Negative for HIV infection by an FDA approved method of detection.
  • Female-Specific Criteria:
  • If a woman is of reproductive potential and sexually active with a male partner, then she agrees to use an effective means of birth control from the time of study enrollment until the last study visit, or to be monogamous with a partner who has had a vasectomy.
  • Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

Who cannot join

  • A volunteer would have been excluded if one or more of the following conditions applied:
  • Prior receipt of licensed or investigational monoclonal antibody.
  • Weight > 115 kg.
  • Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis within the 2 years prior to enrollment that has a reasonable risk of recurrence during the study.
  • Hypertension that is not well controlled.
  • Woman who is breast-feeding, or planning to become pregnant during the study participation.
Show all 9Show fewer
  • Receipt of any investigational study agent within 28 days prior to enrollment.
  • Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the subject including (but not limited to): diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of drug or alcohol abuse, asthma, autoimmune disease, infectious disease, psychiatric disorders, heart disease, or cancer.
  • Known hypersensitivity to hyaluronidase or any of the excipients in ENHANZE™ Drug Product (EDP).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: VRC 609: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

Background:

The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same. N6LS is directed against the HIV virus. There is no HIV in the N6LS study product and you cannot get HIV from this product. This study is the first time N6LS is tested in humans. It was given into a vein in the arm (intravenously, IV) or as an injection underneath the skin (subcutaneously, SC). The study also tested N6LS mixed with an enzyme, rHuPH20 (recombinant human hyaluronidase). rHuPH20 increases the spread of fluids injected underneath your skin (subcutaneously, SC) and allows for the rapid delivery of large volume injections that can be given with a single needle. It was given as a SC infusion using a small needle attached to an infusion pump. Study products were only given to healthy adults who are not infected with HIV.

Read more

Objective:

The main purpose of the study is to see if N6LS alone and N6LS mixed with rHuPH20 is safe in healthy adults. Another goal is to learn how amounts of N6LS in the body change over time.

Study Plan:

Assigned study groups depended on the dose of product, the numbers of times the product was given (once or three times at 12-week intervals), and how the product was given (IV or SC). Blood samples for research were collected at most of the visits. There were about 14 clinic visits over 6 months for all groups who got one dose of product, and about 26 clinic visits over 12 months for the groups who got three doses of product.

Read the detailed description

Study Design:

This is the first study in healthy adults of the N6LS monoclonal antibody (MAb). It was a dose-escalation study to examine safety, tolerability, dose, and pharmacokinetics (PK) of N6LS administered intravenously (IV) and subcutaneously (SC) to healthy adults. For SC administration, N6LS was administered alone or co-administered with the permeation enhancer rHuPH20 enzyme. Primary hypotheses are that N6LS administration to healthy adults will be safe by the IV and SC routes, alone and with rHuPH20 co-administration. A secondary hypothesis is that all N6LS administrations will be detectable in human sera with a definable half-life

Product Description:

N6LS (VRC-HIVMAB091-00-AB) is a human MAb targeted to the HIV-1 CD4 binding site. It was developed by the VRC/NIAID/NIH and manufactured under current Good Manufacturing Practice (cGMP) regulations at the VRC Vaccine Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick, MD. The product was provided as a sterile aqueous buffered solution in 10 mL glass vials at a concentration of 100 mg/mL and volume of 6.25 mL.

Each vial of ENHANZE™ Drug Product (EDP) contains 0.5 mL of rHuPH20 formulated at a concentration of 1 mg/mL (approximately 110,000 U/mL rHuPH20). rHuPH20 is a tissue permeability modifier that depolymerizes hyaluronan (HA), increasing the dispersion of a substance into the subcutaneous space, which enables SC delivery of co-administered antibody (-ies) at higher dose volumes (e.g., >10 mL) that cannot be administered quickly without rHuPH20. EDP is manufactured by Ajinomoto Althea, Inc. (San Diego, CA) for Halozyme Therapeutics, Inc. (San Diego, CA) and is supplied in 2 mL glass vials as a sterile, single-dose, injectable liquid.

Subjects:

Healthy adults, 18-50 years of age.

Study Plan:

This open-label study included 8 dose groups to assess N6LS alone given as a single IV infusion at the 5, 20, or 40 mg/kg dose level (Groups 1,3 and 4); a single SC injection at the 5 mg/kg dose level (Group 2); or in 3 administrations, spaced 12 weeks apart by SC injection at the 5 mg/kg dose level (Group 5), or by IV infusion at the 20 mg/kg dose level (Group 6). Two additional groups assessed N6LS given as a single SC injection mixed with rHuPH20 (2000 U/mL) at 5 mg/kg (Group 7) or 20 mg/kg (Group 8) doses. Enrollment opened with Groups 1, 2 and 5; and was followed by the sequential activation of Groups 3, 4, and 6. With implementation of the two SC N6LS+rHuPH20 arms as a protocol amendment, Group 7 opened first to accrual, followed by Group 8.

Study Duration:

Study participation was approximately 24 weeks for participants in Groups 1-4, 7 and 8; and 48 weeks for participants in Groups 5 and 6.

Conditions
HIV Antibodies
Being tested
VRC-HIVMAB091-00-AB, rHuPH20
Keywords
Immune Cells, bNAb, Plasma Cell, HIV, Immunotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRC-HIVMAB091-00-ABBiological

    N6LS (VRC-HIVMAB091-00-AB) is a human monoclonal antibody targeted to the HIV-1 CD4 binding site.

  • rHuPH20Biological

    Also called EDP

    Recombinant human hyaluronidase PH20 (rHuPH20) is the active ingredient of the investigational ENHANZE™ Drug Product (EDP). EDP is a purified preparation of rHuPH20.

Study groups in NCT03538626
Study groupRoleWhat they receive
Group 1: N6LS (5 mg/kg IV) single doseExperimentalN6LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0)
Receives: Biological: VRC-HIVMAB091-00-AB
Group 2: N6LS (5 mg/kg SC) single doseExperimentalN6LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
Receives: Biological: VRC-HIVMAB091-00-AB
Group 3: N6LS (20 mg/kg IV) single doseExperimentalN6LS (20 mg/kg) administered by IV infusion (Day 0)
Receives: Biological: VRC-HIVMAB091-00-AB
Group 4: N6LS (40 mg/kg IV) single doseExperimentalN6LS (40 mg/kg) administered by IV infusion (Day 0)
Receives: Biological: VRC-HIVMAB091-00-AB
Group 5: N6LS (5 mg/kg SC) repeat doseExperimentalN6LS (5 mg/kg) administered by SC injection (Day 0, Week 12 and Week 24)
Receives: Biological: VRC-HIVMAB091-00-AB
Group 6: N6LS (20 mg/kg IV) repeat doseExperimentalN6LS (20 mg/kg) administered by IV infusion (Day 0, Week 12 and Week 24)
Receives: Biological: VRC-HIVMAB091-00-AB
Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) single doseExperimentalN6LS (5 mg/kg) + rHuPH20 (2000 U/ml) administered by SC injection (Day 0)
Receives: Biological: VRC-HIVMAB091-00-AB; Biological: rHuPH20
Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) single doseExperimentalN6LS (20 mg/kg) + rHuPH20 (2000 U/ml) administered by SC injection (Day 0)
Receives: Biological: VRC-HIVMAB091-00-AB; Biological: rHuPH20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

    Measured: 3 days after each product administration, at approximately Day 3 for all dose groups, and at approximately Day 87 and Day 171 for repeat dose groups

  2. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

    Measured: 3 days after each product administration, at approximately Day 3 for all dose groups, and at approximately Day 87 and Day 171 for repeat dose groups

  3. Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) after each product administration visit. After the Day 56 (8 weeks) after each product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that require ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between a non-serious AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

    Measured: Day 0 through 8 weeks after each product administration, at approximately Week 8 for all dose groups, and at Weeks 20 and 32 for repeat dose groups

  4. Number of Participants With Serious Adverse Events (SAEs) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 24 for single dose groups and at Week 48 for repeat dose groups. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

    Measured: Day 0 after product administration through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

  5. Number of Participants With New Chronic Medical Conditions Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24 for single dose groups and at Week 48 for repeat dose groups. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.

    Measured: Day 0 after product administration through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

  6. Number of Participants With Abnormal Laboratory Measures of Safety Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, alkaline phosphatase (ALP) and Comprehensive Metabolic Panel (CMP)). Complete Blood Count (CBC) with differential and chemistry (ALT, AST, ALP, creatinine and CMP) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.

    Measured: Day 0 through 8 weeks after each product administration, at approximately Week 8 for all dose groups, and at Weeks 20 and 32 for repeat dose groups

Secondary outcomes (6)

  1. Number of Participants Who Produced N6LS Anti-drug Antibodies (ADA) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20

    A three-tiered assay was used for ADA evaluation. The tier 1 screening assay measures specific and non-specific binding of serum proteins to N6LS. The tier 2 assay is a qualitative competition assay in which exogenously added N6LS removes any N6LS-binding proteins from the serum prior to the binding assay. If the addition of the exogenous N6LS results in a reduction of signal, the specificity of N6LS binding is confirmed. The tier 3 assay is a qualitative assay that assesses the ability of N6LS-binding serum protein to prevent N6LS-mediated neutralization of an HIV pseudovirus in vitro. Only samples positive for a tier were analyzed in subsequent tiers.

    Measured: Baseline and Weeks 4 and 8 for single dose groups, or Baseline and Weeks 4, 28, and 32 for repeat dose groups

  2. Pharmacokinetic (PK) Parameters of N6LS: Maximum Observed Serum Concentration (Cmax)

    Cmax is the peak serum concentration that N6LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.

    Measured: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

  3. Pharmacokinetic (PK) Parameters of N6LS: Time to Reach Maximum Observed Serum Concentration (Tmax)

    Tmax is the time it takes to reach Cmax of N6LS after it has been administered; it is determined based on the summary PK curve for each dose group.

    Measured: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

  4. Pharmacokinetic (PK) Parameters of N6LS: Beta Half-life (T1/2b)

    Beta half-life (T1/2b) will be reported for this study. Beta half-life (T1/2b) is the time required for half of the N6LS product to be eliminated from the serum.

    Measured: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

  5. Pharmacokinetic (PK) Parameters of N6LS: Clearance Rate

    Clearance is the rate of N6LS elimination divided by the plasma N6LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).

    Measured: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

  6. Pharmacokinetic (PK) Parameters of N6LS: Volume of Distribution

    Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).

    Measured: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups

Timeline

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

  1. First posted29 May 2018
  2. Study start21 Jun 2018
  3. Primary completion29 Aug 2022
  4. Study completion29 Aug 2022

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03538626
Sponsor's protocol ID
180105
Other IDs
18-I-0105
Acronym
VRC 609
Status last verified
Dec 2023
First submitted
24 May 2018
Last updated
1 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) is not shared because it has limited value in a small phase 1 trial of healthy volunteers. We instead report non-IPD data as required in ClinicalTrials.gov.

Publications

  • Huang J, Kang BH, Ishida E, Zhou T, Griesman T, Sheng Z, Wu F, Doria-Rose NA, Zhang B, McKee K, O'Dell S, Chuang GY, Druz A, Georgiev IS, Schramm CA, Zheng A, Joyce MG, Asokan M, Ransier A, Darko S, Migueles SA, Bailer RT, Louder MK, Alam SM, Parks R, Kelsoe G, Von Holle T, Haynes BF, Douek DC, Hirsch V, Seaman MS, Shapiro L, Mascola JR, Kwong PD, Connors M. Identification of a CD4-Binding-Site Antibody to HIV that Evolved Near-Pan Neutralization Breadth. Immunity. 2016 Nov 15;45(5):1108-1121. doi: 10.1016/j.immuni.2016.10.027.

    PubMed 27851912

  • Gaudinski MR, Coates EE, Houser KV, Chen GL, Yamshchikov G, Saunders JG, Holman LA, Gordon I, Plummer S, Hendel CS, Conan-Cibotti M, Lorenzo MG, Sitar S, Carlton K, Laurencot C, Bailer RT, Narpala S, McDermott AB, Namboodiri AM, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 606 Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults. PLoS Med. 2018 Jan 24;15(1):e1002493. doi: 10.1371/journal.pmed.1002493. eCollection 2018 Jan.

    PubMed 29364886

  • Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch RM, Gordon I, Plummer S, Hendel CS, Pegu A, Conan-Cibotti M, Sitar S, Bailer RT, Narpala S, McDermott A, Louder M, O'Dell S, Mohan S, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Mascola JR, Graham BS; VRC 602 Study Team. Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults. Clin Exp Immunol. 2015 Dec;182(3):289-301. doi: 10.1111/cei.12692. Epub 2015 Sep 24.

    PubMed 26332605

  • Wu RL, Houser KV, Gaudinski MR, Widge AT, Awan SF, Carter CA, Holman LA, Saunders J, Hendel CS, Eshun A, Whalen WR, Wang X, Arthur A, Cunningham JE, Beck A, Casazza JP, Yamshchikov GV, Rothwell RS, Strom L, Dittakavi T, Happe M, Hickman SP, Conan-Cibotti M, Carlton K, Zhang L, Huang Y, Capparelli EV, Castro M, Lin BC, O'Connell S, Flach BS, Bailer RT, Narpala SR, Serebryannyy L, McDermott AB, Arnold FJ, Gall JG, Vazquez S, Berkowitz NM, Gordon IJ, Chen GL, Kwong PD, Huang J, Pierson TC, Connors M, Mascola JR, Zhou T, Doria-Rose NA, Koup RA, Dropulic LK; VRC 609 study team. Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults. Lancet HIV. 2025 Jul;12(7):e485-e495. doi: 10.1016/S2352-3018(25)00041-4. Epub 2025 May 20.

    PubMed 40409326

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-HIVMAB091-00-AB and rHuPH20 in people with HIV Antibodies, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 18 inclusion and 9 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 1 Feb 2024. 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. 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?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20 (time frame: 3 days after each product administration, at approximately Day 3 for all dose groups, and at approximately Day 87 and Day 171 for repeat dose groups). The study lists 6 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 NCT03538626, which also lists 4 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 1 Feb 2024.

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