Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic

NCT03463551 | Unknown Phase 2 DMC

• 1 other identifier: GN16ST187
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.

Conditions

Acute Ischaemic Stroke

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.

  Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).

  7 days±2

Secondary Outcomes (6)

• Mortality

  30 days

• Incidence of serious adverse events throughout the entire study period.

  30 days±5

• Incidence of adverse events of special interest

  30 days±5

• Incidence of adverse reactions, adverse events, serious adverse events and serious adverse reactions, up to visit 7 (30±5 days) post administration of Investigational medicinal product.

  30 days±5

• Modified Rankin Scale (mRS) distribution at day 30.

  At day 30

Study Arms (2)

ABL-101 IV as per dosing cohort + Supplementary O2 for 24h

EXPERIMENTAL

Patients will receive either ABL-101 or placebo (equivalent volume of 0.9% Sodium Chloride) within ascending dose groups of 6 patients each (4 to ABL-101, 2 to placebo).The starting cohort will be Cohort 1: 0.5mL/kg. In the event that the start dose of Cohort 1 is considered intolerable in the opinion of the iDMC based on incidence of patients experiencing dose-limiting toxicities (DLTs), the iDMC will have the option of recommending a lower dose cohort (Cohort -1) of 0.25ml/kg (to a maximum of 25ml) be undertaken. Cohort 1: 0.5 mL/kg to a maximum of 50ml; Cohort 2: 1.5mL/kg to a maximum of 150ml; Cohort 3: 3.0mL/kg to a maximum of 300ml. All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration.

Drug: ABL-101

IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h

PLACEBO COMPARATOR

Cohort 1: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 2: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 3: Volume matched to the calculation used for ABL-101 using patient weight. All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration.

Other: 0.9% NaCl

Interventions

ABL-101 DRUG

ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration.

ABL-101 IV as per dosing cohort + Supplementary O2 for 24h

0.9% NaCl OTHER

Placebo

IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years.
• Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure.
• Ischaemic stroke \<72h after onset.
• Previous functional independence (estimated mRS \<3).
• Capacity to consent.

You may not qualify if:

• Women of child bearing potential.
• Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media).
• Known allergy to ABL-101 or any of its constituents, (including egg phospholipids).
• Clinical need for, or contraindication to, supplemental oxygen.
• Known impaired renal function (eGFR \<30ml/min) precluding radiological contrast.
• Known thrombocytopaenia (platelet count \<150x109) or history of platelet function disorder.
• Known intercurrent infection.
• Known severe COPD or cardiac failure (eg significantly limiting exercise capacity or requiring hospitalisation within the preceding 12 months).
• Known significant liver disease (eg liver failure or cirrhosis, chronic infectious or autoimmune hepatitis, or transaminases \>3 times upper limit of normal).
• Any current medical condition causing impaired immunity (eg HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days.
• Any medical condition potentially limiting survival within the study follow-up period.
• Participation in another CTIMP within preceding 90 days.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Aurum Biosciences Ltd: collaborator

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Keith Muir

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Travers

CONTACT

+44 1412321813; Maureen.Travers@ggc.scot.nhs.uk

Alicia Murray

CONTACT

Alicia.Murray@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 13, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share