Study in Healthy Volunteers Evaluating Safety and Pharmacokinetics of Zika Virus Immune Globulin (ZIKV-IG)

NCT03624946 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ZK-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there are no licensed therapeutics against Zika virus infection. Due to this unmet medical need, Zika Virus Immune Globulin (ZIKV-IG) is being developed as a therapeutic intervention against Zika virus infection. In this first-in-human study, evaluation of ZIKV-IG safety and pharmacokinetics (absorption, metabolism and excretion) will be conducted in healthy adult volunteers.

Conditions

Zika Virus Infection; Zika Virus Disease

Keywords

Zika virus; Human immune globulin; Hyperimmune; Polyclonal antibodies

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events.

  Number of subjects with of adverse events by severity.

  Up to Day 85

Secondary Outcomes (7)

• Assessment of Zika Virus Immune Globulin (ZIKV-IG) Maximum Concentration (Cmax)

  0-2 hours predose to Day 85 postdose

• Assessment of Zika Virus Immune Globulin (ZIKV-IG) Time to Maximum Concentration (Tmax)

  0-2 hours predose up to Day 85 postdose

• Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Up to Last Quantifiable Concentration (AUC0-t)

  0-2 hours predose to Day 85 postdose

• Assessment of Zika Virus Immune Globulin (ZIKV-IG) Area Under the Curve Extrapolated to Infinity (AUC0-inf)

  0-2 hours predose up to Day 85 postdose

• Assessment of Zika Virus Immune Globulin (ZIKV-IG) Clearance (CL)

  0-2 hours predose up to Day 85 postdose

Study Arms (2)

Zika Virus Immune Globulin (ZIKV-IG)

EXPERIMENTAL

Single dose of 50 mL Zika Virus Immune Globulin (ZIKV-IG) will be administered intravenously over 33 minutes.

Biological: Zika Virus Immune Globulin (ZIKV-IG)

Placebo (Saline Solution)

PLACEBO COMPARATOR

Single dose of 50 mL placebo will be administered intravenously over 33 minutes.

Other: Placebo

Interventions

Zika Virus Immune Globulin (ZIKV-IG) BIOLOGICAL

Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.

Also known as: Anti-Zika Immune Globulin (Human), NP-024

Zika Virus Immune Globulin (ZIKV-IG)

Placebo OTHER

Placebo is a normal saline solution (0.9% sodium chloride).

Also known as: Saline solution

Placebo (Saline Solution)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent voluntarily signed by subject.
• Age: 18-55 years of age.
• Blood type O+ or O-.
• Body mass index (BMI) of 18-30.
• Note: minimum body weight of 50 kg.
• For female subjects (with male partners) that are not surgically sterilized (e.g., did not undergo hysterectomy, bilateral oophorectomy or tubal ligation), use of an effective method of contraception throughout the trial including:
• Using hormonal contraception (oral, injectable or implant) continuously for 3 months prior to screening and willing to continue to use hormonal contraception throughout the entire trial.
• Intrauterine device (IUD) inserted at least 1 month prior to screening.
• Double barrier type of birth control measure (e.g., condoms, diaphragms, cervical sponge with spermicide).
• True abstinence.
• For female subjects who are post-menopausal, documented follicle- stimulating hormone (FSH) ≥40 milli-international units per milliliter (mIU/mL) must be obtained. If the FSH is \<40 mIU/mL, the subject must agree to use an acceptable form of contraception (see above).
• Females of childbearing potential without male sexual partners must be willing to maintain their sexual status as it is throughout the study.
• For male subjects that have not had a vasectomy, use of a condom with spermicide or true abstinence for the duration of the study. Note: female partners (that are of childbearing potential) of male study subjects (that have not had a vasectomy) should use one of the effective contraception methods (eg, hormonal contraception, IUD or barrier type). Also, male subjects must not donate sperm for the duration of the study.
• Males without female sexual partners must be willing to maintain their sexual status as it is throughout the study.
• Healthy as determined by principal investigator or a qualified designate based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening.

You may not qualify if:

• Use of any investigational product within the past 30 days.
• Use of any investigational product during the study.
• Individuals with blood type A, B or AB.
• Recipient of any blood product within the past 12 months.
• Plasma donation within 7 days or significant blood loss or blood donation within 56 days of baseline.
• Blood donation at any time during the study.
• Females with a hemoglobin level ≤120 g/L.
• Males with a hemoglobin level \<130 g/L.
• History of hypersensitivity to blood or plasma products.
• History of allergy to latex or rubber.
• History of immunoglobulin A (IgA) deficiency.
• History of hypercoagulable conditions (e.g., deep vein thrombosis or pulmonary embolism).
• History of myocardial infarction.
• History of stroke.
• History of renal impairment/failure.

Sponsors & Collaborators

• Emergent BioSolutions: lead

Study Sites (1)

Syneos Health, Early Phase

Toronto, Ontario, M5V 2T3, Canada

Location

Related Publications (1)

• White J, Tunga P, Anderson DM, Iledan K, Loreth T, Parrera GS, Astacio H, Drobic B, Richardson JS. Results of a Double-Blind, Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Anti-Zika Virus Immunoglobulin. Am J Trop Med Hyg. 2021 Oct 4;105(6):1552-1562. doi: 10.4269/ajtmh.20-1578.

  PMID: 34610572 DERIVED

MeSH Terms

Conditions

Zika Virus Infection

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Due to the limited number of plasma donors used to generate the plasma pool for manufacture of the ZIKV-IG clinical lot, donor plasma with high isoagglutinin titers (e.g., anti-A antibodies) were not excluded from plasma pools used for the manufacture of ZIKV-IG. Therefore, in this study ZIKV-IG was for use by individuals with blood type O only.

Results Point of Contact

• Title: Jason Richardson, Senior Scientist, Clinical Research
• Organization: Emergent BioSolutions Canada Inc.

jrichardson@ebsi.com

204-275-4266

Study Officials

• Vadim Dreyzin, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

• Michael McDonnell, MD

  Syneos Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: June 27, 2018
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: March 18, 2024
• Results First Posted: July 13, 2020

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)