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A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19

Trial Profile

A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Jun 2021

At a glance

  • Drugs Recombinant polyclonal antibody therapy - GigaGen (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Sponsors GigaGen
  • Most Recent Events

    • 04 Jun 2021 Status changed from not yet recruiting to recruiting.
    • 10 May 2021 Status changed from planning to not yet recruiting.
    • 15 Apr 2021 According to a GigaGen media release, this program recently received an IND approval to initiate this study.

Trial Overview

Purpose

to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs)

description: Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
time_frame: Day 1 up to Day 56

Incidence of treatment-emergent adverse events (TEAEs)

description: Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
time_frame: Day 1 up to Day 56

Change from baseline of vital signs, physical examination, and clinical laboratory assessments

description: Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG
time_frame: Day 1 up to Day 56

Incidence of infusion-related reactions (IRR) and hypersensitivity reactions

description: Frequency of IRR and hypersensitivity reactions
time_frame: Day 1 through Day 2

Other Endpoints

Pharmacological evaluation of single doses of GIGA-2050

description: Serum titers of antibodies directed against SARS CoV-2 will be measured for the pharmacological profile of single doses of GIGA-2050
time_frame: Day 1 up to Day 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 18

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

- Participant is ≥ 18 years of age. - Positive result of a SARS CoV-2 RNA diagnostic test result ≤48 hours before enrollment, warranting hospital admission as per Investigator's judgement. - COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan). - Requires oxygen supplementation with FIO2 approximately 30% or greater administered by nasal cannula, mask, or NIV. - Participants can be on other medication on-label to treat COVID-19 respiratory disease that the Investigator deems clinically relevant in combination with the study drug, including corticosteroids. Passage of 24 hours after administration of the EUA drug will be required prior to dosing GIGA-2050. - Men or non-lactating female participants who are surgically sterile or post-menopausal, or a Woman of Childbearing Potential (WCBP) with a negative pregnancy test at screening willing to use highly effective contraception methods.

Patient Exclusion Criteria

- Acute respiratory failure requiring invasive mechanical ventilation or ECMO at enrollment. - Systolic Blood Pressure (SBP) <110 mmHg or heart rate >120 bpm. - Pre-existing heart failure or unstable angina or myocardial infarction in the last month prior to screening. - Pre-existing chronic respiratory condition(s). - Evidence of acute kidney injury, increase of serum creatinine of ≥1.5 x baseline, or urine output of <0.5mL/kg/hr sustained for at least 6 hours once volume repleted. - Aspartate aminotransferase (AST) ≥2.5 x ULN, alanine aminotransferase (ALT) ≥2.5 x ULN, and/or total bilirubin >1.5 x ULN, or severe hepatic impairment. - Known systemic hypersensitivity to recombinant antibody therapies. - Female participant who is pregnant. - Participant is expected to transfer to a non-investigative facility from the investigation site and cannot be monitored for compliance with protocol-required safety monitoring procedures. - Participants who are currently participating or have participated in another clinical trial within 30 days prior to screening.

Trial Details

Identifiers

Identifier Owner
NCT04883138 ClinicalTrials.gov: US National Institutes of Health
GG-GIGA2050-001 -

Organisations

  • Sponsors GigaGen
  • Affiliations GigaGen

Trial Dates

  • Initiation Dates

    Planned : 19 May 2021

    Actual : 24 May 2021

  • Primary Completion Dates

    Planned : 15 Aug 2021

  • End Dates

    Planned : 30 Aug 2021

Other Details

  • Design open; prospective; sequential
  • Phase of Trial Phase I
  • Location USA
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
Recombinant polyclonal antibody therapy - GigaGenPrimary Drug Intravenous Infusion

15 mg GIGA-2050 per kg BW

Participants will receive a single IV infusion of 15 mg GIGA-2050 per kg BW, or as determined by SRC review
Drug: GIGA-2050 (Recombinant Hyperimmune Polyclonal Antibody)

5 mg GIGA-2050 per kg BW

Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW
Drug: GIGA-2050 (Recombinant Hyperimmune Polyclonal Antibody)

50 mg GIGA-2050 per kg BW

Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review
Drug: GIGA-2050 (Recombinant Hyperimmune Polyclonal Antibody)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Jennifer Keller
650 268 4255
gigagentrials@gigagen.com
show details
-
Sean Liu, MD Icahn School of Medicine at Mount Sinai USA

Centres

Centre Name Location Trial Centre Country
-
-
-
-
-
-
GigaGen
-
-
Icahn School of Medicine at Mount Sinai New York, New York USA

Trial History

Event Date Event Type Comment
09 Jun 2021 Other trial event Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 09 Jun 2021
04 Jun 2021 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 09 Jun 2021
17 May 2021 Other trial event New source identified and integrated (NCT04883138) Updated 09 Jun 2021
10 May 2021 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 17 May 2021
15 Apr 2021 Other trial event According to a GigaGen media release, this program recently received an IND approval to initiate this study. Updated 16 Apr 2021
09 Mar 2021 Other trial event According to a GigaGen media release, this trial is expected to start in spring 2021. Updated 16 Mar 2021
09 Apr 2020 New trial record New trial record Updated 09 Apr 2020
30 Mar 2020 Other trial event According to a GigaGen media release,company expects to initiate trial in early 2021. Updated 09 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2021;.

    Available from: URL: http://clinicaltrials.gov
  2. GigaGen. GigaGen Initiates Development of Recombinant Polyclonal Antibody Therapy for COVID-19. Media-Rel 2020;.

    Media Release
  3. Grifols. Grifols reinforces its innovation strategy after completing the acquisition of GigaGen to boost a novel method to generate a wide range of immunoglobulins. Media-Rel 2021;.

    Media Release
  4. GigaGen. GigaGen Publishes Research on Companys Recombinant Hyperimmunes in Nature Biotechnology. Media-Rel 2021;.

    Media Release
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