Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV

NCT04540627 | Completed Phase 1 Results

• 1 other identifier: MB05-P-01-20
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated with Respiratory Syncytial Virus (RSV).

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (3)

• Mean Serum Concentrations (Cmax) for Open-label Palivizumab (Part 1) on Day 12.

  The PK assessment up to and including Day 12 exposure was used as a decision information for the dose to be given to participants in Part 2. Pharmacokinetic exposure data from at least 5 out of 6 participants were required for dose decision making with a projected exposure of ≥40 μg/mL on Day 12 according to the protocol. This was achieved after administration of a single IV dose of Palivizumab at 8 mg/kg. Therefore, a dose of 8 mg/kg was chosen for Part 2.

  In Part 1: before the start of infusion; at end of infusion,15 minutes and 0.5, 1, 4, 8, and 12 hours after infusion; and at 1, 2, 3, 7, and 12 days after infusion.

• Area Under the Viral Load-time Curve (VL-AUC) as Determined by Polymerase Chain Reaction (qRT-PCR) on Nasal Samples, for Double-blind Palivizumab or Placebo (Part 2).

  RSV viral load of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily: Assessment of the Area under the viral load-time curve (VL-AUC)

  From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.

• qRT-PCR Peak Viral Load for Double-blind Palivizumab or Placebo (Part 2).

  Peak viral load of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily.

  From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2

Secondary Outcomes (19)

• Area Under the Viral Load-time Curve (VL-AUC) as Determined by Cell Culture on Nasal Samples, for Double-blind Palivizumab (Part 2).

  From two days post viral challenge (Day 2) to the end of quarantine (Day 12) in Part 2 on nasal samples collected twice daily.

• Cell Culture Peak Viral Load for Double-blind Palivizumab or Placebo (Part 2).

  From Day 2 to Day 12 in Part 2

• Number of Participants With Laboratory-confirmed Infection of RSV-A Memphis 37b in Nasal Samples (Variant 1) for Double-blind Palivizumab or Placebo (Part 2).

  From Day 2 to Day 12 in Part 2

• Number of Participants With Laboratory-confirmed Infection of RSV-A Memphis 37b in Nasal Samples (Variant 2), for Double-blind Palivizumab or Placebo (Part 2).

  From Day 2 to Day 12 in Part 2

• Viral Shedding of RSV-A Memphis 37b in Nasal Samples in Terms of Duration, for Double-blind Palivizumab or Placebo (Part 2).

  From Day 2 to Day 12 in Part 2

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sodium Chloride 0.9% Solution (Normal Saline)

Drug: Placebo; Other: RSV-A Memphis 37b virus

Palivizumab (Synagis™)

ACTIVE COMPARATOR

Sterile vial 50mg/0.5mL

Drug: Palivizumab; Other: RSV-A Memphis 37b virus

Interventions

Palivizumab DRUG

Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg or 15mg/kg, administered at a rate of 1mL/min

Also known as: Synagis™

Palivizumab (Synagis™)

Placebo DRUG

Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min

Placebo

RSV-A Memphis 37b virus OTHER

Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)

Palivizumab (Synagis™); Placebo

Eligibility Criteria

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

You may qualify if:

• An informed consent document signed and dated by the participant and the Investigator.
• Aged between 18 and 55 years old on the day of signing the consent form.
• In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), Electrocardiogram (ECG), and routine laboratory tests as determined by the Investigator.
• A documented medical history prior to enrolment.
• The following criteria are applicable to female participants participating in the study.
• Females of childbearing potential must have a negative pregnancy test prior to enrolment.
• Females of non-childbearing potential:
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• Post- menopausal females; defined as having a history of amenorrhea for \>12 months with no alternative medical cause, and /or by Follicle stimulating hormone (FSH) level \>40mIU/mL, confirmed by laboratory
• Documented status as being surgically sterile (e.g. tubal ligation, hysterectomy, bilateral salpingectomy and bilateral oophorectomy).
• The following criteria apply to female and male participants:
• Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception use must continue until 30 days after the date of viral challenge/last dosing with IMP (whichever occurs last). Highly effective contraception is as described below:
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• Established use of hormonal methods of contraception described below (for a minimum of 2 weeks prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide:
• \. Oral 2. Intravaginal 3. Transdermal b. Intrauterine device (IUD) c. Intrauterine hormone-releasing system (IUS) d. Bilateral tubal ligation e. Male sterilisation (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomised male is the sole partner for that woman.

You may not qualify if:

• Medical History
• History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit.
• a) Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
• b) And/or other major disease that, in the opinion of the Investigator, may put the participant at undue risk, or interfere with a participant completing the study and necessary investigations.
• The following conditions apply:
• Participants with a physician diagnosed underactive thyroid who have been controlled on treatment for at least 6 months with evidence of a normal thyroid function test (TFT) can be included at the discretion of the PI.
• o Participants with a history of psychiatric illness including depression and/or anxiety of any severity within the last 2 years can be included if the Patient Health Questionnaire (PHQ-9) and / or the Generalised Anxiety Disorder Questionnaire (GAD-7) is less than or equal to 4. Participants with a PHQ-9 or GAD-7 score of between 5 and 9 may be included following consultation with a Senior Physician (Clinical Lead for Screening) who may advise further consultation with the PI.
• Participants with physician diagnosed mild Irritable Bowel Syndrome (IBS) not requiring regular treatment can be included at the discretion of the PI.
• Participants who have smoked ≥ 10 pack years at any time \[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\]).
• A total body weight ≤ 50 kg and Body Mass Index (BMI) ≤18 kg/m2 and ≥30kg/m2
• Females who:
• Are breastfeeding, or
• Have been pregnant within 6 months prior to the study.
• History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
• Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (1)

hVIVO Services Limited

London, E1 2AX, United Kingdom

Location

MeSH Terms

Interventions

Palivizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: mAbxience Research SL

susana.millan@mabxience.com

+34917711500

Study Officials

• Sungeen Hill, MD

  hVIVO Services Limited

  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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: September 7, 2020
• Study Start: July 6, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: October 4, 2021
• Results First Posted: October 4, 2021

Record last verified: 2021-09

Locations

GB (1)