PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT06934447: Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE
Official title: Study of BCMA/CD70 Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Childhood-oneset Systemic Lupus Erythematosus
Conditions: CAR T Cell Therapy
Systemic Lupus Erythematosus
BCMA
Summary: This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Interventions:
description: Three dose groups (0.3×105/kg, 1×105/kg, 3×105/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.
name: anti-BCMA/CD70-CAR-T cells
type: Biological
Study arms:
design_group_description: This trial was designed as an open, single-arm, multicenter, dose-increasing trial.
design_group_title: CAR-T treatment group
design_group_type: Experimental
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Collaborators: Chongqing Precision Biotechnology Co., Ltd.
Drug name mappings:
name: Anti-BCMA/CD70 CAR-T cells(The Children's Hospital of Zhejiang University School of Medicine)
lang: EN
Clinical trial NCT03383692: Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Official title: A Phase 1, Multicenter, Open-label, Single Sequence Crossover Study to Evaluate Drug-drug Interaction Potential of OATP1B/CYP3A Inhibitor on the Pharmacokinetics of DS-8201a in Subjects With HER2-expressing Advanced Solid Malignant Tumors
Conditions: Neoplasm Metastasis
Summary: HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test an experimental drug called DS-8201a that has not been approved by the health authorities yet.
DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).
Interventions:
description: DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
name: DS-8201a
type: Drug
description: Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration
name: Ritonavir
other_name: Norvir
type: Drug
description: Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
name: Itraconazole
other_name: Orungal
Sporanox
type: Drug
Study arms:
design_group_description: DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Ritonavir twice daily (BID) on Day 17 of Cycle 2 until Day 21 of Cycle 3
design_group_title: Cohort 1: DS-8201a + Ritonavir
design_group_type: Experimental
design_group_description: DS-8201a will be administered as an intravenous (IV) solution once every 3 weeks (Q3W) + Itraconazole BID on Day 17 of Cycle 2 followed by 200 mg daily (QD) until Day 21 of Cycle 3
design_group_title: Cohort 2: DS-8201a + Itraconazole
design_group_type: Experimental
Sponsor: Daiichi Sankyo Co., Ltd.
Collaborators: AstraZeneca PLC
Drug name mappings:
name: 伊曲康唑
lang: CN
name: Itraconazole
lang: EN
name: イトラコナゾール
lang: JP
name: 德曲妥珠单抗
lang: CN
name: Fam-trastuzumab deruxtecan-NXKI
lang: EN
name: トラスツズマブ デルクステカン（遺伝子組換え）
lang: JP
name: 利托那韦
lang: CN
name: Ritonavir
lang: EN
name: リトナビル
lang: JP
Clinical trial NCT02121509: Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
Official title: Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/750 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)
Conditions: Healthy
Summary: The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.
Interventions:
description: 1 x Linagliptin tablet
name: Linagliptin
type: Drug
description: 2 x Linagliptin/Metformin ER FDC tablet
name: Linagliptin/Metformin ER FDC
type: Drug
description: 3 x Metformin ER tablets
name: Metformin ER
type: Drug
Study arms:
design_group_description: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fasted condition
design_group_title: FDC first, fasted
design_group_type: Experimental
design_group_description: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fasted condition
design_group_title: Single tablets first, fasted
design_group_type: Experimental
design_group_description: Linagliptin/Metformin ER FDC followed by single tablets of linagliptin and metformin ER, fed condition
design_group_title: FDC first, fed
design_group_type: Experimental
design_group_description: single tablets of linagliptin and metformin ER followed by Linagliptin/Metformin ER FDC, fed condition
design_group_title: Single tablets first, fed
design_group_type: Experimental
Sponsor: Boehringer Ingelheim GmbH
Collaborators: Eli Lilly & Co.
Drug name mappings:
name: 利格列汀
lang: CN
name: Linagliptin
lang: EN
name: リナグリプチン
lang: JP
name: 盐酸二甲双胍
lang: CN
name: Metformin Hydrochloride
lang: EN
name: メトホルミン塩酸塩
lang: JP
name: 利格列汀/盐酸二甲双胍
lang: CN
name: Linagliptin/Metformin Hydrochloride
lang: EN
Clinical trial NCT03927573: Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker
Official title: A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSCA Marker
Conditions: Non-small Cell Lung Cancer
Prostate Cancer
Renal Cancer
Transitional Cell Carcinoma
Summary: This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM3PSCA in patients with prostate stem cell antigen (PSCA) expressing cancer types which failed to respond to standard therapy.
Interventions:
description: Infusion of GEM3PSCA, administered intravenously, continuously over 7 days, 2 cycles
name: GEM3PSCA
type: Drug
Study arms:
design_group_description: Application of GEM3PSCA, a PSCA targeted bispecific antibody engaging T-cells
design_group_title: GEM3PSCA
design_group_type: Experimental
Sponsor: AvenCell Europe GmbH
Collaborators: GCP Service International Ltd & Co KG
Drug name mappings:
name: GEM3-PSCA
lang: EN
Clinical trial NCT00016185: Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
Official title: Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol and docetaxel in treating patients who have advanced solid tumors.
Interventions:
name: alvocidib
type: Drug
name: docetaxel
type: Drug
Study arms:
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute
Drug name mappings:
name: 阿伏西地
lang: CN
name: Alvocidib Hydrochloride
lang: EN
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
Clinical trial NCT01178099: An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults
Official title: A Pharmacokinetic and Pharmacodynamic Assessment of Prasugrel in Healthy Adults and Adults With Sickle Cell Disease
Conditions: Anemia, Sickle Cell
Summary: The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).
Interventions:
description: Oral, daily for 12 days
name: Prasugrel
other_name: CS747
Effient
Efient
LY650315
type: Drug
Study arms:
design_group_description: Participants received a single 10 milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
design_group_title: Prasugrel
design_group_type: Experimental
Sponsor: Eli Lilly & Co.
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 盐酸普拉格雷
lang: CN
name: Prasugrel Hydrochloride
lang: EN
name: プラスグレル塩酸塩
lang: JP
Clinical trial NCT04557397: Fruquintinib CYP3A Inhibitor and Inducer Study
Official title: A Phase 1 Open-label 2-Part 2-Period Fixed-sequence Crossover Study To Assess The Effect Of Itraconazole, A Strong CYP3A Inhibitor, And The Effect Of Rifampin, A Strong CYP3A Inducer, On Pharmacokinetics Of Fruquintinib In Healthy Subjects
Conditions: Drug Drug Interaction
Summary: A study to assess the effect of itraconazole, a strong CYP3A inhibitor, and the effect of rifampin, a strong CYP3A inducer, on the pharmacokinetics of fruquintinib in healthy subjects.
Interventions:
description: oral VEGFR inhibitor
name: Fruquintinib
other_name: HMPL-013
type: Drug
description: a synthetic triazole antifungal agent
name: Itraconazole
type: Drug
description: a semisynthetic antibiotic derivative of rifamycin SV
name: Rifampin
type: Drug
Study arms:
design_group_description: Subjects will receive fruquintinib, alone and with itraconazole.
design_group_title: Part A
design_group_type: Other
design_group_description: Subjects will receive fruquintinib, alone and with rifampin.
design_group_title: Part B
design_group_type: Other
Sponsor: Hutchison MediPharma Ltd.
Collaborators: Labcorp Drug Development, Inc.
Drug name mappings:
name: 伊曲康唑
lang: CN
name: Itraconazole
lang: EN
name: イトラコナゾール
lang: JP
name: 利福平
lang: CN
name: Rifampin
lang: EN
name: リファンピシン
lang: JP
name: 呋喹替尼
lang: CN
name: Fruquintinib
lang: EN
name: フルキンチニブ
lang: JP
Clinical trial NCT00150215: A First In Human Study Of PF-00184562 In Healthy Volunteers
Official title: An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
Conditions: Schizophrenia
Summary: The purposes of this study are:
* To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and
* To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
Interventions:
name: PF-00184562
type: Drug
name: Olanzapine
type: Drug
Study arms:
Sponsor: Pfizer Inc.
Collaborators: Pharmaceutical Product Development LLC
Drug name mappings:
name: PF-184562
lang: EN
name: 奥氮平
lang: CN
name: Olanzapine
lang: EN
name: オランザピン
lang: JP
Clinical trial NCT04380207: P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of Intravenous (IV) QPX7728 Alone and in Combination With QPX2014 in Healthy Adult Subjects
Conditions: Bacterial Infections
Summary: QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P. aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes, such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-beta-lactamase (VIM), and class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
Interventions:
description: antibiotic
name: QPX7728
other_name: IV
type: Drug
description: Placebo comparator
name: Placebo
other_name: IV saline
type: Drug
description: antibiotic
name: QPX2014
other_name: IV
type: Drug
Study arms:
design_group_description: antibiotic
design_group_title: QPX7728
design_group_type: Experimental
design_group_description: Matched placebo
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: antibiotic
design_group_title: QPX2014
design_group_type: Experimental
Sponsor: Qpex Biopharma, Inc.
Collaborators: Biomedical Advanced Research & Development Authority (Barda)
Drug name mappings:
name: Xeruborbactam
lang: EN
name: QPX-2014
lang: EN
Clinical trial NCT07217496: N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer
Official title: Phase Ib Trial Combining N-803 and Pembrolizumab With Shorter Duration of Enfortumab Vedotin in Treatment-Naïve Patients With Metastatic Urothelial Carcinoma
Conditions: Metastatic Urothelial Carcinoma
Urothelial Carcinoma
Locally Advanced Urothelial Carcinoma
Urothelial Cancer
Summary: This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
Interventions:
description: Given subcutaneously (SC)
name: Nogapendekin Alfa Inbakicept (N803)
other_name: N803
Nogapendekin Alfa Inbakicept
type: Drug
description: Given intravenously (IV)
name: Enfortumab Vedotin (EV)
other_name: Enfortumab Vedotin
type: Drug
description: Given intravenously (IV)
name: Pembrolizumab
other_name: Keytruda
type: Drug
description: Undergo blood collection for research purposes
name: Research Biospecimen Collection
type: Procedure
description: Undergo radiographic imaging for disease assessment
name: Radiographic Imaging
other_name: Computed tomography (CT)
Magnetic Resonance Imaging (MRI)
type: Procedure
description: Undergo tumor biopsy
name: Tumor Biopsy
type: Procedure
Study arms:
design_group_description: Participants with unresectable locally advanced (LA) or metastatic urothelial carcinoma (mUC) will receive N-803 plus Enfortumab Vedotin (EV) and Pembrolizumab on Day 1 and EV on Day 8 in a repeated 3-week cycle until disease progression or unacceptable toxicity. EV treatment is provided up to 12 cycles. Participants with confirmed clinical benefit based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) at the second or third scan (between 8 to 12 cycles on treatment) will discontinue EV treatment at investigator discretion. After participants discontinue EV treatment, participants may continue to receive N-803 and Pembrolizumab treatment up to 2 years.
design_group_title: Treatment (EV, N-803, pembrolizumab)
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: ImmunityBio, Inc.
Drug name mappings:
name: 诺格白介素α-因奇西普
lang: CN
name: Nogapendekin alfa inbakicept-pmln
lang: EN
name: 维恩妥尤单抗
lang: CN
name: Enfortumab Vedotin-ejfv
lang: EN
name: エンホルツマブ ベドチン(遺伝子組換え)
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
Clinical trial NCT00003925: Combination Chemotherapy In Treating Patients With Advanced Cancer
Official title: Phase I Study of Gemcitabine (Gemzar) and UFT/Leucovorin
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining gemcitabine, fluorouracil-uracil and leucovorin in treating patients who have advanced cancer that has not responded to previous therapy.
Interventions:
name: gemcitabine hydrochloride
type: Drug
name: leucovorin calcium
type: Drug
name: tegafur-uracil
type: Drug
Study arms:
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborators: National Cancer Institute
Drug name mappings:
name: 尿嘧啶替加氟
lang: CN
name: Tegafur/Uracil
lang: EN
name: テガフール/ウラシル
lang: JP
name: 亚叶酸钙
lang: CN
name: Leucovorin Calcium
lang: EN
name: ホリナートカルシウム
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
Clinical trial NCT00532974: A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)
Official title: A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)
Conditions: HIV Infections
Summary: The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.
Interventions:
description: Low dose
name: EP1090
type: Biological
description: High dose
name: EP1090
type: Biological
Study arms:
Sponsor: Epimmune, Inc.
Collaborators: Pharmexa A/S
Pharmexa-Epimmune, Inc.
Drug name mappings:
name: HIV-1 CTL epitope-based DNA vaccine(VaxOnco, Inc.)
lang: EN
Clinical trial NCT07086521: Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)
Official title: A Phase 1, Double-blinded, Randomized, Dose-repeating, Placebo-controlled, Cross-over Study to Assess the Safety and Preliminary Efficacy of Allogeneic ULSC on Disease Severity in Facioscapulohumeral Muscular Dystrophy (FSHD)
Conditions: FSHD - Facioscapulohumeral Muscular Dystrophy
Summary: The goal of this clinical trial is to learn about how an umbilical cord lining-derived stem cell product (ULSC) performs when treating Facioscapulohumeral Muscular Dystrophy (FSHD) 1 or 2. It will assess safety and preliminary efficacy in relieving symptoms of FSHD with ULSC administered in two intravenous (IV) doses of 100 million cells per dose.
The main questions that this study plans to answer are:
* Is ULSC as safe as placebo (a look-alike saline without cells) in repeated IV infusion?
* Does ULSC improve symptoms of FSHD after each dose? Researchers will compare ULSC to placebo.
Participants will:
* Have been diagnosed with FSHD of a Ricci clinical severity score 3 or more.
* Participate in this study for total duration of 21 months with 11 in-person visits and 5 virtual visits.
* Visit the clinic for a total of 4 IV infusions (250 mL) 3 months apart.
* Receive 2 doses of ULSC and 2 doses placebo in either of two sequences, as assigned: ULSC first (Day 0 and Month 3) and placebo second (Month 6 and Month 9), or placebo first (Day 0 and Month 3) and ULSC second (Month 6 and Month 9).
* Return for follow-up visits after each dose and up to 12 months after final dose.
Interventions:
description: Allogeneic umbilical-cord lining stem cells (ULSC) are cryopreserved and supplied in vials to be thawed and prepared for infusion at point of use. Each dose of 1 x 10^8 ULSC will be added to into 250 sterile saline for infusion (total volume of 260 mL volume).
name: ULSC
type: Biological
description: The Placebo will be 250 ml of sterile saline for IV administration.
name: Placebo
type: Biological
Study arms:
design_group_description: Group 1 will receive a dose of 1 x 10^8 ULSC through IV administration on Day 0 and Month 3 (two doses, 2 x 10^8 ULSC in total from both doses). They will then cross-over to Placebo IV administrations on Month 6 and Month 9.
design_group_title: Group 1: ULSC first; Placebo second
design_group_type: Experimental
design_group_description: Group 2 will receive Placebo IV administrations on Day 0 and Month 3. They will then cross-over to receive 1 x 10^8 ULSC IV administrations on Month 6 and Month 9 (2 x 10^8 ULSC in total).
design_group_title: Group 2: Placebo first; ULSC second
design_group_type: Experimental
Sponsor: Restem Group, Inc.
Collaborators: Solve Fshd Holdings Ltd.
Drug name mappings:
name: Restem-L
lang: EN
Clinical trial NCT04658667: HIV Vaccine in HIV-uninfected Adults
Official title: Randomized, Double Blind Evaluation of Late Boost Strategies With IHV01 (FLSC in Aluminum Phosphate) and A244 With or Without ALFQ for HIV-uninfected Participants in the HIV Vaccine Trial RV306 / WRAIR 1920
Conditions: HIV
Summary: The purpose of this study is to test whether delayed boosting (an extra administration of a vaccine) with the IHV01 (FLSC) protein and A244/AHFG with or without ALFQ will cause the body to make higher amounts of antibodies or different types of antibodies after the vaccination.
Interventions:
description: IHV01 consists of the Full-Length Single Chain (FLSC) gp120-CD4 chimera subunit HIV-1 vaccine formulated in aluminum phosphate adjuvant. It is encoded by a synthetic gene, which contains a human codon-optimized HIV (BaL) gp120 sequence followed by human CD4D1D2, with a flexible 20-amino acid linker.
name: IHV01
type: Biological
description: A244 consists of the gp120 envelope glycoprotein HIV-1 subtype CRF_01AE A244 derived from the CM244 CRF_01AE. The A244 gp120 envelope has an 11 amino N-terminal deletion, similar to the A244 protein used in AIDSVAX B/E. The aluminum hydroxide fluid gel (AHFG) adjuvant that is mixed with A244 consists of Rehydragel HPA that is diluted with sterile water for injection to a concentration of 5 + /- 1mg/mL.
name: A244
type: Biological
description: ALFQ (Army Liposomal Formulation) is a liposomal adjuvant containing a synthetic monophosphoryl lipid A (MPLA) with the addition of QS-21.
name: ALFQ
type: Biological
description: Normal saline (Sodium Chloride for injection USP, 0.9%) will be used as placebo.
name: Placebo
type: Other
Study arms:
design_group_description: Participants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg).
design_group_title: Full dose IHV01 and A244
design_group_type: Experimental
design_group_description: Participants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg).
design_group_title: Fractional dose IHV01 and A244
design_group_type: Experimental
design_group_description: Participants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg) plus ALFQ (approximately 0.5mL).
design_group_title: Full dose IHV01 and A244 + ALFQ
design_group_type: Experimental
design_group_description: Participants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg) plus ALFQ (approximately 0.5mL).
design_group_title: Fractional dose IHV01 and A244 + ALFQ
design_group_type: Experimental
design_group_description: Normal saline will serve as a placebo for the trial. All placebo injection volumes will match the study vaccine injection volumes for the group in which a participant has been randomized.
design_group_title: Placebo
design_group_type: Placebo Comparator
Sponsor: U S Army Medical Research & Development Command
Collaborators: Case Western Reserve University
University of Maryland Baltimore
Duke University
Drug name mappings:
name: A244
lang: EN
name: FLSC vaccine(Profectus BioSciences, Inc.)
lang: EN