Tolerability of the perfluorocarbon oxygen carrier ABL-101 in patients with acute ischaemic stroke

Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial with GOLD Imaging Theranostic (POST-IT) - POST-IT

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003232-36-GB

Enrollment

Registered

2017-10-23

Start date

2017-12-20

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischaemic stroke MedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: ABL-101 Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: Perfluoro(t-butylcyclohexane) CAS Number: 84808-64-0

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: • 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 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.; Secondary Objective: To investigate the GOLD imaging technique in patients with acute stroke. To provide data on sample size and event rates to inform the design of a phase 2b randomised, controlled trial with clinical end-points. ;Primary end point(s): Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).;Timepoint(s) of evaluation of this end point: Visit 6 (7±2)	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.; Secondary Objective: To investigate the GOLD imaging technique in patients with acute stroke. To provide data on sample size and event rates to inform the design of a phase 2b randomised, controlled trial with clinical end-points. ;Primary end point(s): Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).;Timepoint(s) of evaluation of this end point: Visit 6 (7±2)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Mortality 2. Incidence of serious adverse events 3. Incidence of AEs of special interest 4. Incidence of ARs, AEs, SAEs, and SARs 5. Modified Rankin Scale (mRS) 6. Follow-up infarct volume on MRI brain ; Timepoint(s) of evaluation of this end point: Secondary endpoints 1 -3 will be evaluated throughout the entire study period. The incidence of ARs, AEs, SAEs, and SARs will be collected up to visit 7 (30 ± 5 days) post administration of IMP. Modified Rankin Scale (mRS) distribution at day 30 Follow-up infarct volume on MRI brain will be assessed at visit 4 at 48 hours (40-72 hours)	—

Measure

Time frame

Secondary end point(s): 1. Mortality 2. Incidence of serious adverse events 3. Incidence of AEs of special interest 4. Incidence of ARs, AEs, SAEs, and SARs 5. Modified Rankin Scale (mRS) 6. Follow-up infarct volume on MRI brain ; Timepoint(s) of evaluation of this end point: Secondary endpoints 1 -3 will be evaluated throughout the entire study period. The incidence of ARs, AEs, SAEs, and SARs will be collected up to visit 7 (30 ± 5 days) post administration of IMP. Modified Rankin Scale (mRS) distribution at day 30 Follow-up infarct volume on MRI brain will be assessed at visit 4 at 48 hours (40-72 hours)

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Countries

United Kingdom

Contacts

Public ContactMaureen Travers

NHS Greater Glasgow & Clyde

maureen.travers@ggc.scot.nhs.uk01412321813

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026